Global Cell and Gene Therapy Industry market Report 2020 presents critical information and factual data about the Cell and Gene Therapy Industry market, providing an overall statistical study of this market on the basis of market drivers, market limitations, and its future prospects. The widespread Cell and Gene Therapy Industry market opportunities and trends are also taken into consideration in Cell and Gene Therapy Industry industry. with growth trends, various stakeholders like investors, traders, suppliers, SWOT analysis Opportunities and Threat to the organization and others.

The Cell and Gene Therapy Industry market report comprises of the key trends which influence the industry growth with respect to the regional terrain and competitive arena. The study highlights the opportunities that will support the industry expansion in existing and untapped markets along with the challenges the business sphere will face. Besides this, the report also offers an intricate analysis of case studies including those of COVID-19 pandemic, with the aim to provide a clear picture of this industry vertical to all shareholders.

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Pivotal pointers from COVID-19 impact assessment:

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Analysis of the regional terrain:

Highlights of the Cell and Gene Therapy Industry market report:

Key Coverage of report:

Impact of the latest technological innovations on the Cell and Gene Therapy Industry market

Key growth strategies adopted by the prominent market players to address the challenges and restraints put forward by the COVID-19 pandemic

Historical and current trends likely to affect the overall market dynamics of the Cell and Gene Therapy Industry market

Growth assessment of the various market segments over the forecast timeline

Regional and global presence of major market players in the Cell and Gene Therapy Industry market

Table of Content:

1 Cell and Gene Therapy Industry market Introduction and Market Overview

1.1 Objectives of the Study

1.2 Overview of Cell and Gene Therapy Industry market

1.3 Scope of The Study

1.3.1 Key Market Segments

1.3.2 Players Covered

1.3.3 COVID-19's impact on the Cell and Gene Therapy Industry industry

1.4 Methodology of The Study

1.5 Research Data Source

2 Executive Summary

2.1 Market Overview

2.1.1 Global Cell and Gene Therapy Industry market Size, 2015 - 2020

2.1.2 Global Cell and Gene Therapy Industry market Size by Type, 2015 - 2020

2.1.3 Global Cell and Gene Therapy Industry market Size by Application, 2015 - 2020

2.1.4 Global Cell and Gene Therapy Industry market Size by Region, 2015 - 2025

2.2 Business Environment Analysis

2.2.1 Global COVID-19 Status and Economic Overview

2.2.2 Influence of COVID-19 Outbreak on Cell and Gene Therapy Industry Industry Development

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See more here:
Cell and Gene Therapy Industry Market with manufacturers, Application, regions and SWOT Analysis 2025 - CueReport

Recommendation and review posted by Bethany Smith

The treatment stops the body's own immune system attacking healthy eye cells.

Experts said the breakthrough signalled a "new era" for patients suffering from dry age-related macular degeneration, a type of blindness previously untreatable.

The research, which featured trials in the UK, Europe and the US, found new drugs injected into the eye can preserve sight by slowing the spread of the disease.

Dry macular degeneration is caused when the immune system becomes faulty and destroys healthy cells.

Researchers found two new injectable drugs which are being used to combat this - Pegcetacoplan and Zimura. Both work by introducing proteins which stop the faulty inflammatory process from causing an attack on eye cell membranes.

The monthly injectable treatment has so far been tested in 286 patients.

It saw disease progression slow by up to 29 percent over a year compared with those who received a placebo, or dummy treatment.

Scientists believe the drugs will continue to stop the spread of the disease when used over a longer period.

It is also hoped the revolutionary therapy will be on the market for widespread use within four years.

Professor Paulo Stanga, a worldleading eye surgeon who works at the London Vision Clinic in Harley Street, has been involved with the research. He said: "These results are exciting and fantastic news.

"At present there is no approved treatment for this previously irreversible AMD and over the years patients have been told nothing could be done. We know increasing numbers of patients will end up with complete loss of central vision if we do not find a solution.

"It is essential to treat dry AMD in the early stages before there is more loss of vision.

"The evidence from this trial suggests the treatment preserves vision over time.

"There is already evidence to be confident we can slow progression of dry AMD, potentially saving tens of thousands of people from sight loss, which is fantastic."

Alongside the injection-based trials there are two other potential drug targets for dry AMD for those who have already lost some vision.

The first is a one-time gene therapy surgically delivered into the eye.

This is currently being studied in an early trial known as the Focus Study. It is designed to dampen down the activity of the faulty genes that cause inflammation.

Another study is looking into low level light therapy. This has been shown to stimulate oxygen and blood flow in the eye, reducing inflammation and increasing vision in a trial of 30 subjects.

This study found patients were able to read a smaller line of letters on an eye chart than before treatment.

Macular degeneration currently affects up to 700,000 people in the UK.

There are two types, dry and wet, with a largely equal split in the numbers of cases.

It is estimated there will be 1.3 million people suffering from late stage AMD by 2050 - almost double the number today.

The scientific work was published in the medical journal Ophthalmology.

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Blindness breakthrough as monthly jabs first to half leading cause of sight loss - Express

Recommendation and review posted by Bethany Smith

Impact Analysis of Covid-19

The complete version of the Report will include the impact of the COVID-19, and anticipated change on the future outlook of the industry, by taking into the account the political, economic, social, and technological parameters.

Get Sample PDF Including COVID19 Impact Analysis Of Gene Therapy, https://www.coherentmarketinsights.com/insight/request-pdf/1774

The Gene Therapy Market is expected to have a highly positive outlook for the next five years 2020-2027 according to a recently released Gene Therapy Market research report. The report has been added to his large database by Coherent Market Insights. This report is a guide that covers key strategic developments of the market including acquisitions & mergers, new technology launch, agreements, partnerships, collaborations & joint ventures, research & development, technology, and regional expansion of major participants involved in the market on the global and regional basis.

It also going to elaborate the opportunities out there in micro niches for stakeholders to take a position, step by step investigation of the competitive landscape and even commodity professional services of famous players which include GlaxoSmithKline plc, Bluebird Bio, Inc., Adaptimmune Therapeutics plc, Celgene Corporation, Shanghai Sunway Biotech Co. Ltd., Merck KGaA, Transgene SA, and OncoGenex Pharmaceuticals, Inc.

The key features of the Gene Therapy Market report 2020-2027 are the organization, extensive amount of analysis, and data from previous and current years as well as forecast data for the next five years. Most of the report is made up of tables, charts, and figures that give our clients a clear picture of the market.

The comprehensive value chain analysis of the Gene Therapy market will assist in attaining better product differentiation, along with a detailed understanding of the core competency of each activity involved. The market attractiveness analysis provided in the report measures the potential value of the Gene Therapy providing business strategists with the latest growth opportunities.

Questions have been answered at Gene Therapy Market report:

Economy Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, along with Strategies) The length of the global Gene Therapy market opportunity? How share promote Gene Therapy their worth from different manufacturing brands? Which will be the niches at which players profiling with thorough plans, financials, and also recent advancements should set a presence? Which will be the anticipated growth rates for your own Gene Therapy economy altogether and also for every segment inside? Which will be the Gene Therapy application and types and forecast accompanied closely by producers?

The research report on the Gene Therapy market evaluates the growth trends of the industry through historical study and estimates future prospects based on comprehensive research. The report extensively provides market share, growth, trends, and forecasts for the period 2020-2027. The market size in terms of revenue (USD MN) is calculated for the study period along with the details of the factors affecting the market growth (drivers and restraints).

Key Topics Covered:

Part 01: Executive SummaryPart 02: Scope Of The ReportPart 03: Research MethodologyPart 04: Market Landscape Market Ecosystem Market Characteristics Market Segmentation Analysis

Part 05: Market Sizing Market Definition Market Sizing 2020 Market Size And Forecast 2020-2027

Part 06: Five Forces Analysis Bargaining Power of Buyers Bargaining Power of Suppliers Threat of New Entrants Threat of Substitutes Threat of Rivalry Market Condition

Part 07: Customer LandscapePart 08: Regional Landscape Geographical Segmentation Regional Comparison Americas Market Size And Forecast 2020-2027 EMEA Market Size And Forecast 2020-2027 APAC Market Size And Forecast 2020-2027

Part 09: Decision FrameworkPart 10: Drivers And Challenges Market Drivers Market Challenges

Part 11: Market TrendsPart 12: Vendor Landscape Overview Landscape Disruption Vendors Covered Vendor Classification Market Positioning Of Vendors

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Coherent Market Insights is a global market intelligence and consulting organization focused on assisting our plethora of clients achieve transformational growth by helping them make critical business decisions. We are headquartered in India, having office at global financial capital in the U.S. and sales consultants in United Kingdom and Japan. Our client base includes players from across various business verticals in over 150 countries worldwide. We pride ourselves in catering to clients across the length and width of the horizon, from Fortune 500 enlisted companies, to not-for-profit organization, and startups looking to establish a foothold in the market. We excel in offering unmatched actionable market intelligence across various industry verticals, including chemicals and materials, healthcare, and food & beverages, consumer goods, packaging, semiconductors, software and services, Telecom, and Automotive. We offer syndicated market intelligence reports, customized research solutions, and consulting services.

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Gene Therapy Market Professional Industry Overview 2020 Segmentation and Development Analysis BY 2027 - Science Examiner

Recommendation and review posted by Bethany Smith

Horizon Discovery Group plc

Half Year Trading Update

Cambridge, UK, 29 July 2020:Horizon Discovery Group plc (LSE: HZD) ("Horizon", "the Group" or the Company), a cell engineering company focused on commercialising the application of gene editing and gene modulation to accelerate scientific innovation and biopharmaceutical drug development, today provides an unaudited pre-close trading update for the six months ended 30 June 2020. The Company plans to report its half year 2020 results on 17 August 2020.

Financials

Horizon expects to report half year 2020 revenues of approximately 22.4 million (HY 2019: 26.1 million, c. -13.9%)1, approximately 22.0 million (c. -15.5%) on a constant currency basis. The change was largely due to the rapid reduction of academic research work caused by the COVID-19 pandemic impacting the Groups Research Reagents business unit and was broadly in line with Board expectations. The greatest impact was seen in the second quarter of 2020, most notably in April. This was then followed by a period of sustained recovery, which resulted in large parts of the business regaining momentum and returning towards 2019 levels of revenue by the end of June 2020.

Gross margin from continuing operations1 is expected to be approximately 66.0% (HY 2019: 71.2%). The margin decline is primarily due to the impact of COVID-19 on manufacturing costs and additional provisioning for aged inventory. Adjusted EBITDA is expected to be a loss of 4.6 million (HY 2019: 0.0 million1).

The Groups cash position was bolstered by a successful Placing in April 2020, which raised 6.9 million in gross proceeds, and was further strengthened by the implementation of enhanced cash control measures implemented in April. Taking this into account, the Group had cash and cash equivalents of 23.6 million as of 30 June 2020 (HY 2019: 24.8 million; FY 2019: 18.8 million). The Groups strong balance sheet provides financial flexibility to ensure operational delivery and continued strategic investment to fully benefit from market recovery.

1. In December 2019, the Company completed its divestment of its non-core In Vivo business unit to Envigo RMS LLC. Revenues generated in the period in the financial year that the Company owned In Vivo are excluded from the Companys continuing operations

Terry Pizzie, Chief Executive Officer of Horizon Discovery, commented:

Thanks to the fantastic efforts of our staff, we have continued to operate effectively throughout the crisis and have built stronger and deeper relationships with our biopharma customers based on our ability to add value in difficult conditions. Our customers have increasingly adopted outsourcing as a

solution to their own business challenges and we have become recognised as an invaluable long-term partner.

We expect the trend for increased outsourcing to continue, for these relationships to endure and facilitate high level access within our biopharma customer base that will help lay the foundations for commercialising our new high growth areas.

We are encouraged by our H2 2020 prospects and look forward to the remainder of the year with optimism and confidence about the Groups strategy and prospects.

Performance by Business Unit

Research ReagentsRevenue for the Research Reagents business was 16.0 million, down 15.3% against the same period in the prior year, with trading significantly impacted by COVID-19. Academic and government research labs account for approximately 50% of the Research Reagents business units revenues, and the closure of many of these facilities starting from mid-March, led to a rapid reduction in orders for RNAi and CRISPR reagents and cell line products.

In April, revenues for reagents reduced to a low of 56% of the same period in 2019. Trading started to improve in May as researchers began to return to work and, by the end of June, trading had recovered to 2019 levels.

As a result of the repositioning of the Groups Cell Line Engineering (CLE) business, with a new value proposition, pricing and go-to-market strategy introduced at the end of Q1 2020, demand has increased significantly in Q2. This is not yet reflected in the reported revenues as a result of c. 10-week project delivery and revenue recognition timelines. Given the significant increase in demand, the Group has committed to additional investment in lab equipment and automation of approximately 3.5 million over the next 18 months, to further increase capacity to levels 25 times those of January 2019. To conserve near-term cash, this investment will be largely funded through leasing equipment. More detail on this will be provided at the Groups half year 2020 results. In H2 2020, the Group also expects to benefit from demand for CLE from academic and government research, as most researchers return to work following the loosening of lock-down restrictions.

For the first time, the results for this business unit now include Diagnostics due to operational synergies, including e-commerce. Diagnostics revenues were down 8.5% from H1 2019. The Group expects this part of the business to return to growth in H2 2020.

ScreeningOverall revenue of 4.4 million represented a 2.8% increase on the same period in the prior year. In line with typical biopharma spending patterns, the Screening business saw a relatively flat first quarter. However, after the initial slowdown in late March, the Group saw a notable increase in orders from its biopharma customer base, as these companies responded to the challenges of the COVID-19 crisis by prioritising key projects and supplementing their own in-house resources by outsourcing both CRISPR screening and High Throughput Screening (HTS). The Group expects the trend for outsourcing to continue in H2 2020.

BioProductionOverall revenue of 2.0 million for H1 2020 was down 29.7% on the same period in the prior year, with revenues suffering from the impact of COVID-19 restrictions and changes of prioritisation within bioproduction facilities globally, resulting in delays to evaluations of our CHO cell line. Pick-up in activity in May and June indicates a potential road to recovery in H2 2020.

The Group remains excited about its collaboration with Mammoth Biosciences and the development of a suite of next generation engineered CHO lines as these initiatives are progressing well.

Base EditingAfter establishing a new Base Editing business unit in H1 2020, the Group has making good progress working with its early access customers, including a large global pharma company, to assess and shape the development of this technology. The Group believes this technology is well-positioned to benefit both the CAR-T therapy market and the gene therapy market.

Supporting COVID-19 Research

Horizons products and services are being used by our customers in several important areas of COVID-19 research, including in efforts to uncover the virus weaknesses, find targets for potential therapies and help guide vaccine design. The Groups RNAi and CRISPR reagents are being used by high profile organisations such as the Krogan Lab, based at University of California San Francisco. Nevan Krogan, PhD, Professor of Cellular Molecular Pharmacology at UCSF, who leads the facility, has cited Horizons ability to be quick and flexible in meeting the laboratorys needs for CRISPR and siRNA reagents as being instrumental in the rapid progression of its COVID research.

Outlook

The fundamental drivers and demands for Horizons products and services remain strong and the Group is confident of a return to growth in the second half of 2020. Horizon remains focused on executing its strategy, and the management team is excited about the continued expansion of its screening market and the opening-up of new high growth areas that will come from commercialising its investments in BioProduction and Base Editing.

Horizons strong balance sheet position provides financial flexibility to ensure operational delivery and continued R&D investment to fully benefit from market recovery. The Group will continue to prudently manage the business, ensuring operational delivery and focused investment in order to be in a strong position as markets normalise.

Ends

Capital Markets Webcast and conference call today:

Horizon Discovery will host a Capital Markets Webinar for institutional investors and analysts at 15:00pm BST. There will be a simultaneous live conference call. The joining instructions are as follows:

Webinar link: https://www.lsegissuerservices.com/spark/HorizonDiscoveryGroup/events/4ab97991-3d5b-45de-959b-9486da1e2d60

Conference call details for analysts and investors:

The webcast and presentation slides will be available on the Groups website shortly after the event: https://horizondiscoveryplc.com/news-events/presentations-and-recordings/

For further information from Horizon Discovery Group plc, please contact:

Horizon Discovery Group plcTerry Pizzie, Chief Executive OfficerJayesh Pankhania, Chief Financial OfficerJon Davies, Head of Investor RelationsTel: +44 (0) 1223 655 580

Numis Securities Limited (Broker and NOMAD)Freddie Barnfield / Duncan MonteithTel: +44 (0) 207 260 1000

Consilium Strategic Communications (Financial Media and UK Investor Relations)Mary-Jane Elliott / Matthew Neal / Melissa GardinerTel: +44 (0) 20 3709 5700Email:horizon@consilium-comms.com

Zyme Communications (Trade and Regional Media)Lorna CuddonT Tel: +44 (0) 7811 996 942Email:Lorna.cuddon@zymecommunications.com

Westwicke, an ICR Company (US Investor Relations)Stephanie CarringtonTel. +1 646-277-1282Email:horizondiscovery@icrinc.com

About Horizon Discovery Group plc http://www.horizondiscovery.com

Horizon Discovery Group plc (LSE: HZD) ("Horizon") is a cell engineering company focused on commercializing the application of gene editing and gene modulation to accelerate scientific innovation and biopharmaceutical drug development. Horizons portfolio of tools and services is built on decades of experience in altering the expression of genes across mammalian and human cell types to provide cell engineering tools and services to customers in three key areas of the therapeutic ecosystem: basic research, drug discovery and development and therapeutic applications. Horizons offerings support and enable critical elements of the drug development and therapeutic value chain, particularly in the area of precision medicine. Horizons customers include biopharmaceutical and diagnostics companies, contract research and manufacturing organizations and academic researchers across the globe.

Horizon is headquartered in Cambridge, UK with offices in USA and Japan. The Group is listed on the London Stock Exchange's AIM market under the ticker HZD.

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Horizon Discovery Group plc - Horizon Discovery Group plc Half Year Trading Update - GlobeNewswire

Recommendation and review posted by Bethany Smith

Scientists at the University of California-San Diego report that an investigational drug candidate called tipifarnib showed promise in treating head and neck squamous cell carcinoma (HNSCC) tumors with mutations in the HRAS gene. Head and neck cancer is one of the leading causes of cancer-related deaths worldwide, and squamous cell carcinomas account for the majority of these cases.

The study Tipifarnib as a Precision Therapy for HRAS-Mutant Head and Neck Squamous Cell Carcinomas, published in Molecular Cancer Therapeutics, findings shed new light on the HRAS gene, a member of the RAS family of genes that produce proteins that regulate a variety of cellular processes, including growth, movement and differentiation. In 4 to 8 percent of HNSCC tumors, the HRAS gene is mutated.

Tipifarnib is a potent and highly selective inhibitor of farnesyltransferase (FT). FT catalyzes the post-translational attachment of farnesyl groups to signaling proteins that are required for localization to cell membranes. Although all RAS isoforms are FT substrates, only HRAS is exclusively dependent upon farnesylation, raising the possibility that HRAS mutant tumors might be susceptible to tipifarnib-mediated inhibition of FT, write the investigators.

Here, we report the characterization of tipifarnib activity in a wide panel of HRAS mutant and wild type HNSCC xenograft models. Tipifarnib treatment displaced both mutant and wild type HRAS from membranes but only inhibited proliferation, survival and spheroid formation of HRAS mutant cells. In vivo, tipifarnib treatment induced tumor stasis or regression in all six HRAS mutant xenografts tested but displayed no activity in six HRAS wild type PDX models.

Mechanistically, drug treatment resulted in reduction of MAPK pathway signaling, inhibition of proliferation and induction of apoptosis and robust abrogation of neovascularization, apparently via effects on both tumor cells and endothelial cells. Bioinformatics and quantitative image analysis further revealed that FT inhibition induces progressive squamous cell differentiation in tipifarnib-treated HNSCC PDX.

These preclinical findings support that HRAS represents a druggable oncogene in HNSCC through FT inhibition by tipifarnib, thereby identifying a precision therapeutic option for HNSCCs harboring HRAS mutations.

This preclinical research has the potential to extend to the entire HNSCC patient community, whose overall survival rates are limited in recurrent or metastatic disease, and existing therapeutic options that are far from optimal, with response rates of roughly 10 to 20 percent, said senior co-author J. Silvio Gutkind, PhD, Distinguished Professor of Pharmacology and associate director of basic science at UC San Diego Moores Cancer Center.

These preclinical findings support the idea that HRAS represents a druggable oncogene in HNSCC through tipifarnibs inhibition of a key enzyme. It is a precision therapeutic option for HNSCCs harboring HRAS mutations.

In the study, UC San Diego researchers found that cell line- and patient-derived HNSCC models harboring HRAS mutations were highly sensitive to tipifarnib, which the authors said has demonstrated encouraging preliminary clinical activity in patients with relapsed or refractory HRAS-mutant HNSCC to date.

Currently, Kura Oncology, a San Diego-based biopharmaceutical company, is conducting a nationwide clinical trialto assess the safety and efficacy of tipifarnib in head and neck cancer with HRAS mutations. Employees of Kura are co-authors of the new paper. UC San Diego is not part of the trial.

Treatment with tipifarnib, wrote study authors, had a multifaceted effect on the biology of HRAS-mutant HNSCC tumors, reducing oncogenic signaling and proliferation, while increasing apoptosis, blocking angiogenesis, and driving squamous differentiation of tumors.

Head and neck cancer accounts for approximately 650,000 cases and 330,000 deaths annually worldwide. In the United States, approximately 4 percent of all cancers are head and neck, with an estimated 65,630 persons diagnosed each year, two-thirds of them men and 14,500 deaths, according to Cancer.Net.

More here:
Critical Recurring Mutation Identified in Head and Neck Cancers - Genetic Engineering & Biotechnology News

Recommendation and review posted by Bethany Smith

Manufacturing cell therapies is technically and financially demanding; as a result, despite therapy developers gradually strengthening their in-house expertise, they are also becoming increasingly reliant on contract service providers

Roots Analysis is pleased to announce the publication of its recent study, titled, Cell Therapy Manufacturing Market (3rd Edition), 2019 2030.

The report features an extensive study of the current market landscape and future opportunities associated with cell therapy manufacturing. It focuses on both contract manufacturers, as well as developers with in-house manufacturing facilities, offering in-depth analyses of the various business entities that are engaged in this domain, across different global regions. Amongst other elements, the report includes:

Read Detailed Analysis: https://www.rootsanalysis.com/reports/view_document/cell-therapy-manufacturing/285.html

A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)

Type of therapy

Source of cells

Scale of operation

Purpose of manufacturing

Key geographical regions

Key companies covered in the report

For more information, please click on the following link:

https://www.rootsanalysis.com/reports/view_document/cell-therapy-manufacturing/285.html

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If youd like help with your growing business needs, get in touch at [emailprotected]

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

[emailprotected]

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Cell Therapy Manufacturing Market is estimated to reach close to USD 11 Billion by 2030, predicts Roots Analysis - Market Research Posts

Recommendation and review posted by Bethany Smith

Cancer Gene Therapy Market Report 2020-26: COVID-19 Impact Analysis, Growth, and Change by Facts and Factors provide the strategists, marketers, and senior management with the critical information they need to assess the Cancer Gene Therapy market.

Leading market research company Facts & Factors (FnF) published the latest research report on "Cancer Gene Therapy Market By Type (Ex-vivo and In-vivo) and By Product (Viral Vectors, Non-viral Vectors, and Others): Global Industry Outlook, Market Size, Business Intelligence, Consumer Preferences, Statistical Surveys, Comprehensive Analysis, Historical Developments, Current Trends, and Forecasts, 20202026" in its database which covering in-depth analysis of size, segmentation market growth, and market share, competitive Landscape, Detailed List of Key Buyers and End-Users.

This report focuses on the Cancer Gene Therapy market which is experiencing strong growth. The report gives a guide to the Cancer Gene Therapy market which will be shaping and changing our lives over the next six years and beyond, including the market's response to the challenge of the global pandemic.

Request an Exclusive Free Sample Report of Cancer Gene Therapy Market: http://www.fnfresearch.com/sample/cancer-gene-therapy-market-by-type-ex-vivo-898

(The sample of this report is readily available on request).

Benefits of Requesting a FREE Sample Report Before Purchase:

(Note: The sample of this report is updated with COVID-19 analysis before delivery)

Spreadsheet Chapters May include

Market Consumption in US$ by Country by Product/Service by Year. Market, Financial, Competitive, Market Segmentation, Industry, Critical Parameters, Marketing Costs, Markets, Decision Makers, Performance, Product Launch.

Some of Following Top Market Players Profile Included in This Report:

Cancer Gene Therapy Market Analysis by Leading Market Players

Leading top market players in the Cancer Gene Therapy market are analyzed in the report along with their business overview, operations, geographical locations, financial analysis, SWOT profile, and Carbon Black products & services.

COVID-19- Current Scenario, Potential Impact, and Strategic Situation Analysis

Various communities and companies are doing their best to function and perform, and eventually cope with the challenges raised by COVID-19 pandemic. The COVID-19 pandemic had a negative impact on the market size for the year 2020, with small and medium scale companies struggling to sustain their businesses in the near term future. Industry leaders are now focusing to create new business practices to deal with crisis situations like COVID-19 pandemic.

Enquire About COVID-19 Updates for This Report: http://www.fnfresearch.com/inquiry/cancer-gene-therapy-market-by-type-ex-vivo-898

The report covers market characteristics, market size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the markets historic and forecast market growth by geography. It places the market within the context of the wider Cancer Gene Therapy market, and compares it with other markets.

The report contains a deep analysis of the Cancer Gene Therapy market with size in terms of both value and volume. The report provides a clear insight into current and future developments of the Cancer Gene Therapy market. It provides essential insights into Cancer Gene Therapy market revenue for the top 21 regional and national, and forecast until 2026.

Request Customized Copy of Report @ http://www.fnfresearch.com/customization/cancer-gene-therapy-market-by-type-ex-vivo-898

(We customize your report according to your research need. Ask our sales team for report customization.)

Free Customization

This report includes Free Customization which generally involves a breakout of particular industries or country data at no additional charge. An analyst call can be arranged as part of this which is included in the free customization offering. The Cancer Gene Therapy Market can be customized to the country level or any other market segment.

The report concludes with the profiles of the key players in the Cancer Gene Therapy market. The key players are evaluated on various parameters such as business overview, development, sales value analysis, and recent development. The emerging players are evaluated on various parameters such as business overview, promising vaccines in the clinical development with phase, platform technology, and recent development.

For More Report Details, Visit: http://www.fnfresearch.com/cancer-gene-therapy-market-by-type-ex-vivo-898

KEY REPORT POINTERS & HIGHLIGHTS:

About Us:

Facts & Factors is a leading market research company and offers customized research reports and consulting services. Facts & Factors aims at management consulting, industry chain research, and advanced research to assist our clients by providing planned revenue model for their business. Our report and services are used by prestigious academic institutions, start-ups, and companies globally to understand the international and regional business background. Our wide-ranging database offers statistics and detailed analysis of different industries worldwide that help the clients in achieving sustainable progress. The well-organized reports help clients in developing strategies and making informed business decisions.

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Cancer Gene Therapy Market Size & Trends 2020 Analysis and Growth Forecast till 2026 | Updated Report With COVID-19 Impact Analysis - Northwest...

Recommendation and review posted by Bethany Smith

Roots Analysis has announced the addition of Non-Viral Transfection Reagents and Systems Market, 2020-2030 report to its list of offerings.

Over time, innovative approaches surrounding the development of potential therapies using non-viral transfection systems have prompted several companies to commercialize proprietary technologies to facilitate gene transfer into cells, via a variety of physical, chemical and other non-viral methods. The growing demand for safe and effective genetically engineered ATMPs is likely to further propel the opportunity for non-viral transfection system developers.

To order this 220+ page report, which features 100+ figures and 125+ tables, please visit this link

Key Market Insights

More than 110 companies claim to offer different types of non-viral transfection systems

The majority of players engaged in the development and commercialization of non-viral transfection systems offer reagents (52%), followed by companies offering electroporation-based transfection systems (17%) and other non-viral transfection systems (31%).

13,000+ patents related to non-viral transfection systems filed in the last three years

Over 50% of patents were filed in North America, and were primarily focused on novel transfection methods and affiliated technologies for use in therapy development, cellular reprogramming and gene editing.

300+ registered trials, as of January 2020, claim to involve non-viral transfection systems

Majority of the abovementioned clinical studies are / were focused on the evaluation of gene therapies, most of which are / were being evaluated for the treatment of oncological disorders. Further, it is worth noting that close to 50% of these trials were initiated in the last five years alone.

Over 500 cell / gene therapy developers are likely to enter into partnership with non-viral transfection system providers

It is worth noting that most of the players that are likely to enter into partnership with companies engaged in this domain are based in North America (52%), followed by those headquartered in Asia-Pacific (29%) and Europe (19%).

Revenues from the sales of non-viral transfection systems intended for research purposes, currently represent majority of the market share

By 2030, the contribution (in terms of sales-based revenues) of non-viral transfection systems for clinical applications, is anticipated to increase to 30% of the overall market. Further, the analysis presented in the report demonstrates that, in the foreseen future, around 50% of the markets revenues are likely to come in from the sales of electroporation-based transfection systems.

To request a sample copy / brochure of this report, please visit this link

Key Questions Answered

The USD 1.4 billion (by 2030) financial opportunity within the non-viral transfection reagents and systems market has been analyzed across the following segments:

Type of Transfection System

End-User

Application Area

Key Geographical Regions

The report features inputs from eminent industry stakeholders, according to whom, a significant increase in adoption of non-viral transfection systems is anticipated in clinical applications, in the foreseen future. The report includes detailed transcripts of the discussions held with the following experts:

The research includes detailed profiles of key players engaged in this domain; each profile features an overview of the company, its financial information (if available), recent developments and an informed future outlook.

For additional details, please visit

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Non-Viral Transfection Reagents And Systems Market is projected to be worth USD 1.4 billion by 2030, growing at a CAGR of 9.2%, claims Roots Analysis...

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The Protein Expression Market report 2020 covers all the significant developments which are recently being adopted across the global market. The prime objective of the Protein Expression market report is to provides an in-depth analysis of all market dynamics including drivers and restraints, and trends, and opportunities. The Protein Expression market report covers both the demand and supply aspects of the market. The report also highlighted the future trends in the Protein Expression market that will impact the demand during the forecast period.

Scope of the Report:

As per the , protein expression is the way in which proteins are modified, synthesized, and regulated in living organisms. The term is applicable to either the object of study or the laboratory techniques required to manufacture proteins. Proteins are regulated and synthesized depending upon the functional need in the host cell. The translation, transcription, and post-translational modifications are the three processes involved in protein expression.

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Market Overview:

Some of the Top Key Players of Protein Expression Market Report Are:

Report Highlights:

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Key Market Trends:

Cell Free Expression is the Largest Segment Under Expression System that is Expected to Grow During the Forecast Period

The cell-free protein expression is well-established in the market, due to the acceptance of it and this protein expression is performed without the use of living cells. This technique has many advantages over other protein expression techniques and because of its advantages, it is widely used. Due to the advantages of cell-free protein techniques, such as increased speed, ability to express toxic proteins, ease of amino acid type selective labeling, among others, these are making the cell expression market to grow.

Therefore, the unique technology may increase the growth of the cell-free expression market, which in turn, is expected to boost the protein expression market.

North America is the Largest Growing Market that is Expected to Continue the Same Trend Over the Forecast Period

North America is the largest market for protein expression and is expected to dominate the overall protein expression market due to factors like the presence of well-established healthcare infrastructure in these regions combined with the intense R&D activities carried out. The United States protein expression market is driven by factors, such as an increase in the usage of protein technologies, the rapid evolution of the pharmaceutical industry in the region, and the presence of several companies in the region itself.

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Detailed TOC of Protein Expression Market Report 2020-2024:

1 INTRODUCTION1.1 Study Deliverables1.2 Study Assumptions1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS4.1 Market Overview4.2 Market Drivers4.2.1 Rise in the R&D Activity in the Pharma Sector4.2.2 Opportunities in the Field of Proteomics4.2.3 Advancements in the Biologics Market set to Boost the Market Growth4.2.4 Increasing Incidences of Chronic Diseases4.3 Market Restraints4.3.1 High Cost of Protein Expression Reagents and Instruments4.3.2 Increasing Consolidation and High Barriers for New Entrants4.4 Porters Five Forces Analysis4.4.1 Threat of New Entrants4.4.2 Bargaining Power of Buyers/Consumers4.4.3 Bargaining Power of Suppliers4.4.4 Threat of Substitute Products4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION5.1 By Expression System5.1.1 Cell-Free Expression5.1.2 Bacterial Expression5.1.3 Yeast Expression5.1.4 Algal Expression5.1.5 Insect Expression5.1.6 Mammalian Expression5.1.7 Other Expression Systems5.2 By Product5.2.1 Instrument5.2.2 Reagent5.2.3 Service5.2.4 Other Products5.3 By End User5.3.1 Academia5.3.2 Industry5.3.3 Other End Users5.4 Geography5.4.1 North America5.4.1.1 US5.4.1.2 Canada5.4.1.3 Mexico5.4.2 Europe5.4.2.1 Germany5.4.2.2 UK5.4.2.3 France5.4.2.4 Italy5.4.2.5 Spain5.4.2.6 Rest of Europe5.4.3 Asia-Pacific5.4.3.1 China5.4.3.2 Japan5.4.3.3 India5.4.3.4 Australia5.4.3.5 South Korea5.4.3.6 Rest of Asia-Pacific5.4.4 Middle East & Africa5.4.4.1 GCC5.4.4.2 South Africa5.4.4.3 Rest of Middle East & Africa5.4.5 South America5.4.5.1 Brazil5.4.5.2 Argentina5.4.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE6.1 Company Profiles6.1.1 Agilent Technologies Inc.6.1.2 Bio-Rad Technologies6.1.3 EMD Millipore6.1.4 Takara Bio Inc.6.1.5 New England Biolabs Inc.6.1.6 Oxford Expression Technologies Ltd6.1.7 Promega Corporation6.1.8 Qiagen NV6.1.9 Sigma-Aldrich Corporation6.1.10 Thermo Fisher Scientific Inc.

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

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Novato Aug 1, 2020 (Thomson StreetEvents) -- Edited Transcript of Ultragenyx Pharmaceutical Inc earnings conference call or presentation Thursday, July 30, 2020 at 9:00:00pm GMT

* Camille L. Bedrosian

Ultragenyx Pharmaceutical Inc. - Chief Medical Officer & Executive VP

* Emil D. Kakkis

Ultragenyx Pharmaceutical Inc. - President, CEO & Director

Ultragenyx Pharmaceutical Inc. - Executive VP & Chief Commercial Officer

Ultragenyx Pharmaceutical Inc. - CFO & Executive VP

* Andrea R. Tan

* Swapnil A. Malekar

Sanford C. Bernstein & Co., LLC., Research Division - VP

Ladies and gentlemen, thank you for standing by, and welcome to the Ultragenyx Second Quarter of 2020 Financial Results and Corporate Update Conference Call. (Operator Instructions)

And without further ado, I would like to hand the conference over to Mr. Joshua Higa. Thank you. Please go ahead, sir.

Good afternoon, and welcome to the Ultragenyx Financial Results and Corporate Update Conference Call for the Second Quarter 2020. We have issued a press release detailing our financial results, which you can find on our website at ultragenyx.com. I am Joshua Higa, Director of Investor Relations. Joining me on this call are Emil Kakkis, Chief Executive Officer and President; Shalini Sharp, Chief Financial Officer; Camille Bedrosian, Chief Medical Officer; and Erik Harris, Chief Commercial Officer.

I would like to remind investors that this call will include forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the types of statements identified as forward-looking in our 2019 annual report on Form 10-K that was filed on February 14, 2020, our quarterly report on Form 10-Q that will be filed soon and our subsequent periodic reports filed with the SEC, which will all be available on our website in the Investors section. These forward-looking statements represent our views only as of the date of this call and involve substantial risks and uncertainties, including many that are beyond our control. Please note the actual results could differ materially from those projected in any forward-looking statement. For a further description of the risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements as well as risks related to our business, see our periodic reports filed with the SEC.

I will now turn the call over to Emil.

Emil D. Kakkis, Ultragenyx Pharmaceutical Inc. - President, CEO & Director [3]

--------------------------------------------------------------------------------

Good afternoon, and thank you, everyone, for joining us on today's call. I'll start with our -- our call with a general update on our progress, and then turn it over to Erik, Shalini and Camille to provide more detailed updates on their

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Second quarter was highly productive for Ultragenyx. In the span of just 2 weeks in June, we received our third and fourth FDA approval in our first 10 years as a company. The first was Crysvita for tumor-induced osteomalacia, or TIO, which is now the second indication of the product after its approval for XLH in 2018. The second was Dojolvi for long-chain fatty acid oxidation defect or LC-FAOD, a group of 6 distinct inborn errors of metabolism. These are the first approved treatments for either of these debilitating diseases. In both cases, we were able to secure full FDA approval based on our Phase II study, supplemented by data from expanded access programs. This significantly reduced the time to develop for these therapies for patients with no other FDA options.

Our established approved products continued to perform well, Crysvita in XLH, and Mepsevii continued to grow as we enter the third year post approval. We've developed a great team and strong relationships in both medical genetics and in endocrinology fields with these earlier launches, and this will enable efficient launches in both TIO and LC-FAOD, despite some expected impact from COVID-19.

Moving to our gene therapy platform and programs. There have been significant recent clinical data updates for all 3 programs. At ASGCT, we presented data on both our GSDIa and OTC deficiency program. For GSDIa, all patients across all 3 cohorts in the Phase I/II study have responded to DTX401 gene therapy with the patients in the latest cohort more rapidly tapering their use of cornstarch and oral glucose replacement therapy that is enabled now by the expression of the transgene in our vector.

For OTC, we've now confirmed that 6 out of 9 patients in the study are responders to DTX301 gene therapy, including all 3 of the patients in the highest dose cohort. These updates further solidify our confidence in both programs as Phase III planning continues.

The third gene therapy update was for hemophilia A program led by our partner, Bayer. The [PI] on the ongoing Phase I/II presented data at ISTH on the third cohort from the study. As with prior cohorts, these latest data show sustained and clinically meaningful Factor VIII increases competitive with other hem A program and a near complete reduction in spontaneous bleeds. As a reminder, the Bayer program is our first partner gene therapy program and first-to-use material from our large-scale HeLa producer cell line system.

In the first quarter of this year, we initiated a gene therapy platform partnership with Daiichi Sankyo, in which they have nonexclusive access to our HeLa and HEK293 manufacturing system. Technology transfer related to that license has since been initiated, and we will receive $25 million in milestone payments when it is complete.

So with multiple collaborations in place, 3 products demonstrating positive clinical results, our gene therapy platform is on very solid footing as a source of multiple potential treatments.

I'll now turn the call over to Erik to go into more detail on the launches of Dojolvi in LC-FAOD and Crysvita in TIO as well as progress with our other commercial programs.

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Erik Harris, Ultragenyx Pharmaceutical Inc. - Executive VP & Chief Commercial Officer [4]

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Thank you, Emil. I will start with recapping our launch plans for Dojolvi then cover Crysvita. As you saw last week, Dojolvi is now commercially available to U.S. patients with LC-FOAD. Dojolvi is the first approved therapy for LC-FAOD, which is a severe, lifelong and life-threatening disease. We have initiated the process of working with commercial and government payers to ensure that Dojolvi is accessible for all LC-FAOD patients as indicated in the broad FDA label.

In the first week of launch, we received start forms from multiple doctors and centers of excellence, and we have shipped commercial therapy to our first patients. Just this week, the first reimbursements were approved for patients. We also had one newborn already prescribed Dojolvi whose older sibling had died at a very young age with FAOD. It is important to recognize that the reimbursement process does take time as various payers establish their new market policies. As a result, we expect the Dojolvi launch to build gradually over time and most of our 2020 revenue for the product to come from EU-named patient sales.

In the early stages of the U.S. launch, we are focused on transitioning the approximately 80 patients currently on clinical drug in the U.S. to reimburse commercial therapy. Our team has started conversations with these physicians at our clinical sites to provide information about these transitions, which we expect to complete in the upcoming months, dependent on payers' new-to-market coverage policies. Overall, we estimate that there are approximately 2,000 to 3,500 patients with LC-FAOD. The vast majority of these patients are seen at approximately 160 metabolic genetic centers. We are very familiar with these centers and their physicians based on our experiences with Mepsevii, Crysvita and our OTC and GSDIa programs. As a result, our incremental commercial investment will be minimal for this new launch.

And while launching in the midst of the COVID-19 pandemic is not ideal, the work that we have done to adapt to the current situation for Mepsevii and Crysvita will be extremely helpful as we launch Dojolvi. These adaptations, coupled with the patient's ability to take Dojolvi at home since it is an oral therapy, along with a high unmet need, give us confidence that we will be able to have a successful launch.

Turning now to Crysvita, which we are also launched -- currently launching it in U.S. for tumor-induced osteomalacia, or TIO, and have begun to treat our first commercial TIO patients. Many of the potential prescribers are the same group of endocrinology specialists that have become familiar with Crysvita for XLH over the last couple of years, so we are able to leverage our current commercial infrastructure. TIO, however, is much less common than XLH, affecting about 500 to 1,000 Americans, and it can take a long time to diagnose. Our initial focus is on conversion of clinical trials and compassionate use patients.

Similar to Dojolvi, we expect payers to update their policies for Crysvita to add the TIO indication over time. Good news is that the J-code for Crysvita remains the same for both XLH and TIO indications, which will simplify the buy-and-bill process for payers. To date, we have had multiple starts and patient reimbursements for Crysvita in TIO. We expect a gradual and steady revenue build in this new approved indication.

Crysvita for XLH continues to do well in spite of COVID-19-related challenges. Our patient support services team has reached out proactively to all of our existing patients individually to ensure continuity of care. Since the COVID-19 pandemic, we continue to receive new start forms and increase the number of patients on reimbursed therapy. Our field teams have done a noteworthy job in adjusting to this environment with our ATPs and have started to effectively use virtual platforms to engage with them. We expect to further build momentum as the country begins to reopen.

Across Latin America, there is a strong patient community that has driven a lot of awareness and demand for Crysvita. In Brazil, the region's largest market, this is seen in the steadily growing numbers of injunctions that are being granted and funded by both state and federal governments. Similarly, in Colombia and Argentina, the number of patients on reimbursed named patient treatment increases. Over time, we expect Latin America to provide a more meaningful contribution to revenue as the launch in this region progresses.

Because of the team's efforts to maintain continuity of care while also finding new and creative ways to reach patients, Crysvita's performance through the second quarter of 2020 has been strong. We are maintaining our revenue guidance of $125 million to $140 million for Crysvita revenue in the Ultragenyx territories. As a reminder, this range includes Crysvita and XLH and TIO and covers both profit share, revenue in North America as well as product sales in other regions.

With that, I'll turn the call over to Shalini who will walk through our financial results.

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Shalini Sharp, Ultragenyx Pharmaceutical Inc. - CFO & Executive VP [5]

--------------------------------------------------------------------------------

Thank you, Erik, and good afternoon, everyone. We issued a press release earlier today that included a financial update, which I will briefly summarize.

Total revenue for the 3 months ending June 30, 2020, was $61.7 million. For the quarter ended June 30, 2020, Crysvita revenue in the Ultragenyx territories was $32.4 million. This includes $29.8 million in collaboration revenue in the North American profit share territory and net product sales in other regions of $2.5 million.

Total royalty revenue related to the sales of Crysvita in the European territory was $5 million, which includes $1.5 million for sales in the region prior to January 1, 2020, from a change in estimate and release of reserves by our collaboration partner.

Mepsevii products revenue for the second quarter of 2020 was $4.2 million, and UX007 named patient revenue was $1.3 million. We also recognized $18.9 million of revenue related to the collaboration and license agreement with Daiichi Sankyo that was executed in March of 2020.

Our total operating expenses were $124.8 million for the second quarter of 2020, which includes research and development expenses of $80.7 million and SG&A expenses of $42.3 million. We expect our R&D costs to continue increasing over time as we advance additional product candidates from preclinical development into early and pivotal clinical studies. We also expect SG&A to modestly increase over the coming quarters as we support the expansion of our existing commercial programs and the launch of Dojolvi for LC-FAOD and Crysvita for TIO. We expect the split of R&D versus SG&A expense to remain fairly consistent.

In 2020 to date, approximately 17% of our operating expenses are noncash.

In the second quarter of 2020, we reported net income of $25.3 million or $0.42 per basic share and $0.41 per diluted share. This compares to a net loss of $93.7 million or $1.59 per share basic and diluted for the second quarter of 2019. The net income for the second quarter of 2020 includes a $95.2 million unrealized gain from the fair value adjustment on the investment in the Arcturus equity and the $18.9 million of collaboration revenue related to our agreement with Daiichi Sankyo. These were partially offset by $8.4 million in noncash interest expense on the liability related to the sale of future royalties.

Recall in the second quarter, we exercised our option to purchase 600,000 shares of Arcturus common stock at $16 per share. Upon completion of the additional equity purchase, Ultragenyx owns 3 million shares and continues to be Arcturus' largest shareholder.

For the first half of 2020, cash use in operations was $7.8 million, which includes $134.9 million of operating cash received from Daiichi Sankyo related to the collaboration and license agreement. We ended the second quarter of 2020 with $817.5 million in cash, cash equivalents and available for sale investments.

Moving to our guidance for 2020. We are currently maintaining the guidance range that we shared at the beginning of the year and affirmed on our first quarter earnings call. We anticipate Crysvita revenue to Ultragenyx in our territories to be between $125 million and $140 million. Those territories include North America, Latin America and Turkey and exclude the European royalty, as this was monetized in the transaction that was completed with Royalty Pharma that was announced in December of 2019. We continue to monitor the situation as the COVID pandemic persists.

I would now like to turn the call to Camille who will provide an update on our clinical programs.

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Camille L. Bedrosian, Ultragenyx Pharmaceutical Inc. - Chief Medical Officer & Executive VP [6]

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Thank you, Shalini, and good afternoon, everyone. I will review our 2 new FDA approvals and progress with our Angelman syndrome program before handing back to Emil to provide more detail on our recent gene therapy clinical updates.

Starting with Dojolvi for long-chain fatty acid oxidation disorders, or LC-FAOD, a devastating disease with significant morbidities despite newborn screening and use of available management options. On June 30, we received the first-ever FDA approval of a treatment for patients with LC-FAOD. The approval spans all 6 types of LC-FAODs and applies to both pediatric and adult patients. As Erik's team works to make Dojolvi broadly available to patients living with this debilitating and dangerous disorder, the clinical and regulatory teams will be focused on 2 areas of next steps for the program.

First, we are seeking approval for Dojolvi in other regions around the world. We had previously submitted a marketing application to Anvisa in Brazil and more recently made a new drug submission in Canada where we have been granted priority review. Our discussions with the European Medicines Agency are ongoing. And in the meantime, we will continue to make the product available to the more than 70, 7-0, patients with LC-FAOD, who are receiving it based on requests from physicians seeking the product for reimbursed named patient treatment in France and Italy.

The development team's other area of focus going forward for Dojolvi is the implementation of our disease monitoring program or DMP. As a reminder, the DMP is a long-term, fully sponsored observational study of Dojolvi in LC-FAOD in at least 300 patients for a target of 10 years. The DMP will encompass all post-marketing requirements from the FDA in the single study.

Disease monitoring programs are just one development in innovation we are employing at Ultragenyx. For example, the DMP we initiated for XLH in 2018 has enrolled very rapidly. As a reminder, patients in the LC-FAOD DMP may or may not be receiving Dojolvi. Those patients who receive therapy in our DMPs all receive commercial reimbursed drug. This enables us to minimize post-marketing requirement costs while generating robust, high-quality data from these very large and very long-term studies.

Moving on to Crysvita for tumor-induced osteomalacia, or TIO, a rare debilitating disease for which approximately half of patients have tumors that cannot be surgically removed, leaving them with no other current treatment options. We've received FDA approval of the Crysvita supplemental BLA less than 2 weeks before the Dojolvi approval. The FDA approval for both pediatric and adult patients was based on data from 2 single-arm Phase II study that followed 27 patients with TIO for up to 144 weeks. In these studies, Crysvita was associated with increases in serum phosphorus and improvements in osteomalacia and healing of bone lesions. Similar to our other approved therapies, we will be implementing a long-term, fully sponsored observational DMP that will enroll at least 20 patients and who will be followed for over a 10-year period.

Shifting to Crysvita for X-linked hypophosphatemia, or XLH, which is approved by the U.S. FDA and Health Canada for the treatment of adult and pediatric patients 6 months of age and older with this rare bone disease. Recall also that Crysvita is approved in Brazil with a slightly different indication. Our partner, Kyowa Kirin, recently announced a positive opinion from the Committee for Medicinal Products for Human Use, or CHMP, in Europe to expand the XLH European approval to now include adults and, therefore, is labeled now for all patients at least 1 year of age. The initial EU approval only covered pediatric and adolescent patients who are still growing. Kyowa Kirin expects a final European Commission decision in the second half of this year.

Our first approved therapy, Mepsevii, which is approved for the treatment of mucopolysaccharidosis type 7 or Sly Syndrome occurring in approximately 200 pediatric and adult patients around the world, recently received a positive opinion from the CHMP on the type 2 variation. This variation would expand the EMA approval information to include long-term effects of Mepsevii on the reduction of urinary glycosaminoglycans, or uGAGs, and improvements in the multi-domain Clinical Responder Index as well as 6-minute walk test. We anticipate a formal decision from the European Commission in the second half of 2020.

I will now turn to our program with GeneTx Biotherapeutics to advance GTX-102, an antisense oligonucleotide for the treatment of Angelman syndrome. Angelman syndrome, as you know, affects approximately 60,000 patients worldwide and is a devastating neurogenetic disorder with a broad spectrum of disease manifestations, including speech and cognitive impairment, ataxia or balance issues, sleep dysfunction and seizures. There are no approved treatment options. This disease is a neurodevelopmental disorder and not neurodegenerative. So there is the possibility to reverse some of the manifestations.

Our partner GeneTx initiated the Phase I/II study of GTX-102 earlier this year, marking the first ASO to move into the clinic for Angelman syndrome. The first 2 cohorts have been fully enrolled, and patients have received multiple doses. Safety and efficacy data from the first 2 dose-escalating cohorts are currently being evaluated, and enrollment and dosing at the next dose levels are expected to resume shortly. To

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all we have achieved so far in 2020, and we will drive continued progress for the programs going forward. I want to commend our internal teams for successfully pushing through 2 concurrent FDA reviews as well as the joint team with GeneTx for its impressive progress with a potential therapy for Angelman syndrome. And importantly, I want to again thank the patients, families, caregivers and physicians who participated in the clinical program in LC-FAOD and TIO and those currently participating in the Angelman program, particularly in light of COVID-19.

I will now turn it back to Emil who will provide more detail on our gene therapies in development.

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Emil D. Kakkis, Ultragenyx Pharmaceutical Inc. - President, CEO & Director [7]

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Thank you, Camille. As mentioned in my opening remarks, we had important data read outs from all 3 clinical gene therapy programs during Q2. Starting with DTX401 for Glycogen Storage Disease Type Ia. GSDIa is a life-threatening disease that requires patients to take cornstarch every 3 to 4 hours to avoid severe hypoglycemia and the risk of death as well as long-term complications. We presented at ASGCT the first data from a confirmatory cohort 3 on 6e12 dose as well as longer-term data from the earlier cohort. All cohort 3 patients responded to DTX401, as we saw in the earlier cohort. Cohort 3 patients, though, reduced their cornstarch usage at a faster rate by an average of 57% at week 12 versus 38% and 14%, at the same time point for the other 2 cohorts.

Looking at the longer-term data from cohorts 1 and 2, these patients reduce cornstarch use by an average of 83% with 4 of 6 patients discontinued daytime cornstarch use altogether. 2 patients have completely terminated all cornstarch use. These results suggest that DTX401 is dramatically changing the lives of these patients who, prior to gene therapy, would have been at risk for death with such significant reductions in cornstarch use. We continue to follow all patients in the study and expect to put out additional data on cohort 3 in the second half of this year. We plan to have an end of Phase II meeting with FDA in the same time frame as we gear up for our Phase III study in early 2021, depending on the impact of COVID-19.

Moving on to DTX301, a gene therapy for the treatment of ornithine transcarbamylase deficiency or OTC. OTC is the most common of the urea cycle disorders caused by an inability to detoxify ammonia into urea. And OTC patients can experience metabolic crisis that can result in neurologic issues, hospitalizations and coma. It sometimes results in death. The ASGCT data was an update to the initial cohort 3 data from January. ASGCT included 3 major updates. First, patient 9 is now confirmed as a responder to DTX301, following multiple sustained ureagenesis increases. His volume levels have remained stable at normal range over that time. 6 of 9 patients in the study are now confirmed responders, including all 3 patients in the highest-dose cohort 3.

Second, patient 8, a previous responder, is now along the path of becoming a complete responder after discontinuing scavenger therapy and starting to relax their diet. Third, all 3 of the previously disclosed complete responders remained stable through up to 2 years of follow-up. They remained well despite discontinuation of alternative therapies and the restricted diet for more than 1 year now.

The next step for this program is to treat 3 more patients at the cohort 3 dose with prophylactic steroids. Due to COVID-19, we have not yet dosed a patient in the prophylactic steroid cohort, but we are aiming to have data by the end of 2020. We intend to hold an end of Phase II meeting with the FDA and plan to start the Phase III in the first half of 2021.

In addition to these ASGCT updates, data was presented at the recent ISTH meeting on the hemophilia A gene therapy developed by our partner, Bayer. The new data covered the third dose cohort of 2e13 GC for HeLa in 2 patients in the Phase I/II study. DTX201 led to Factor VIII expression levels of 72% and 12.9% of normal at weeks 28 and 26. Of note, there were no spontaneous bleeds after reaching peak expression, including discontinuation of prophylaxis. One of the patients experienced a traumatic bleed but without the need for Factor VIII replacement therapy.

An update on the first 4 patients treated at the lower dose cohort showed stable Factor VIII expression after up to 16 months of follow-up. This provides further validation of Bayer's hemophilia program, including a relatively low dose, as well as Ultragenyx's HeLa production system. The safety and efficacy is competitive with other hem A programs with good safety so far.

To close out with the prepared remarks, as you can see, we made substantial progress so far in 2020 and expect the same through the second half of the year. I'm proud that the company has been able to make all of this progress in the midst of the ongoing COVID-19 pandemic. The team has adapted and found creative ways to continue working with and supporting patients, their families and their health care providers.

With 4 approved programs, a strong balance sheet and one of the most experienced rare development organizations and an exceptional commercial team globally, Ultragenyx is poised for substantial progress in our development and commercial goals as a next-generation rare disease company. While we have accomplished a great deal in our first decade, we will continue to pursue the smart, efficient and effective development, setting the bar for effective rare disease development and commercialization using the exceptional team and company we've built to bring even more therapies to patients. We will do so with great urgency and dynamic development and commercialization as required to overcome the inevitable challenges, especially in the first-ever treatment for rare diseases.

Thank you for joining us today, and let's move on to your questions.

================================================================================

Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question is from Tazeen Ahmad of Bank of America.

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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [2]

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Emil, just a little bit of color on Crysvita for the quarter. It seems like KHK have provided some commentary that COVID had some bit of an effect on new patient adds and might have even had some interruptions for continuing patients. Can you give us a little bit of color on -- to the extent you can on -- the level of impact that we've seen in 2Q? And then as it relates to TIO, how are you thinking about the initial ramp? Or how should we be thinking about expectations as it would still be launching into the COVID environment?

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Emil D. Kakkis, Ultragenyx Pharmaceutical Inc. - President, CEO & Director [3]

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Very good. So on Crysvita in the U.S., I think we've been managing it very well. And we did -- we talked a little about the proactive effort, and I'll let Erik finish with that in a moment a little bit about the impact. We are probably not seeing the same impact they're seeing, but our territories are different. And so I think it has to be a factor in thinking through.

TIO is a relatively small indication that is slowly diagnosed, so we expect it's going to take time to build slowly as we continue to add patients.

Erik, maybe you can add a little bit on the Crysvita impact and our management of it in the second quarter.

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Read more from the original source:
Edited Transcript of RARE.OQ earnings conference call or presentation 30-Jul-20 9:00pm GMT - Yahoo Finance

Recommendation and review posted by Bethany Smith

Roots Analysis has done a detailed study on Biopharma Contract Manufacturing Market (3rd Edition), 2019-2030, covering key aspects of the industrys evolution and identifying potential future growth opportunities.

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Read Detailed Analysis: https://www.rootsanalysis.com/reports/view_document/biopharma-contract-manufacturing-market-3rd-edition-2019-2030/250.html

The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:

Commonly Outsourced Business Operations

Types of Expression System

Company Size

Scale of Operation

Key Geographical Region

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The Biopharmaceutical Contract Manufacturing Market (3rd edition), 2019 2030 report features an extensive study on the contract service providers...

Recommendation and review posted by Bethany Smith

Roots Analysis has announced the addition of Global Stem Cells Market: Focus on Clinical Therapies, 20202030 (Based on Source (Allogeneic, Autologous); Origin (Adult, Embryonic); Type (Hematopoietic, Mesenchymal, Progenitor); Lineage (Amniotic Fluid, Adipose Tissue, Bone Marrow, Cardiosphere, Chondrocytes, Corneal Tissue, Cord Blood, Dental Pulp, Neural Tissue Placenta, Peripheral Blood, Stromal Cells); and Potency (Multipotent, Pluripotent)) report to its list of offerings.

There is a growing body of evidence supporting the vast applicability and superiority of treatment outcomes of stem cell therapies, compared to conventional treatment options. In fact, the unmet needs within this domain have spurred the establishment of many start-ups in recent years.

To order this 500+ page report, which features 185+ figures and 220+ tables, please visit this link

Key Market Insights

Over 280 stem cell therapies are under development, most of which are allogeneic products

More than 50% of the pipeline candidates are in the mid to late phase trials (phase II and above), and allogenic therapies (majority of which are derived from the bone marrow) make up 65% of the pipeline.

70% of pipeline candidates are based on mesenchymal stem cells

It is worth highlighting that the abovementioned therapies are designed to treat musculoskeletal (22%), neurological (21%) and cardiovascular (15%) disorders. On the other hand, hematopoietic stem cell-based products are mostly being evaluated for the treatment of oncological disorders, primarily hematological malignancies.

Close to 85% stem cell therapy developers are based in North America and Asia-Pacific regions

Within these regions, the US, China, South Korea and Japan, have emerged as key R&D hubs for stem cell therapies. It is worth noting that majority of the initiatives in this domain are driven by small / mid-sized companies

Over 1,500 grants were awarded for stem cell research, since 2015

More than 45% of the total amount was awarded under the R01 mechanism (which supports research projects). The NCI, NHLBI, NICHD, NIDDK, NIGMS and OD emerged as key organizations that have offered financial support for time periods exceeding 25 years as well.

Outsourcing has become indispensable to R&D and manufacturing activity in this domain

Presently, more than 80 industry / non-industry players, based in different regions across the globe, claim to provide contract development and manufacturing services to cater to the unmet needs of therapy developers. Examples include (in alphabetical order) Bio Elpida, Cell and Gene Therapy Catapult, Cell Tech Pharmed, GenCure, KBI Biopharma, Lonza, MEDINET, Nikon CeLL innovation, Roslin Cell Therapies, WuXi Advanced Therapies and YposKesi.

North America and Asia-Pacific markets are anticipated to capture over 80% share by 2030

The stem cell therapies market is anticipated to witness an annualized growth rate of over 30% during the next decade. Interestingly, the market in China / broader Asia-Pacific region is anticipated to grow at a relatively faster rate.

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Key Questions Answered

The USD 8.5 billion (by 2030) financial opportunity within the stem cell therapies market has been analyzed across the following segments:

The report features inputs from eminent industry stakeholders, according to whom stem cell therapies are currently considered to be a promising alternatives for the treatment of a myriad of disease indications, with the potential to overcome challenges associated with conventional treatment options. The report includes detailed transcripts of discussions held with the following experts:

The research covers brief profiles of several companies (including those listed below); each profile features an overview of the company, financial information (if available), stem cell therapy portfolio and an informed future outlook.

For additional details, please visit

https://www.rootsanalysis.com/reports/view_document/stem-cells-market/296.html or email [emailprotected]

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With over 280 therapies under evaluation, the stem cell therapy market is estimated to be worth USD 8.5 Billion by 2030, claims Roots Analysis -...

Recommendation and review posted by Bethany Smith

New Delhi: Cancer takes innumerable lives each year, and so does the unavailability of cancer treatment due to lack of funds. 33-year-old Nushafreen Palsetia, a software engineer based in Mumbai, was recently diagnosed with a very aggressive form of cancer. Despite a relapse, what helped was life-saving support pouring from over 1,700 donors.

Nushafreen was first diagnosed with Non-Hodgkin Lymphoma in April 2019. After a year of enduring aggressive treatment, she tried to get back to her normal life and work. Unfortunately, Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL), cancer relapsed in her liver in May 2020 which was an unexpected major shock, leaving her and all of her family overwhelmed.

Doctors planned to perform an autologous (her own stem cells) bone marrow transplant in India after the chemotherapy but further tests showed involvement of the bone marrow as well. Hence, her treating doctor recommended the modern CAR-T Cell therapy treatment, available only in the USA, UK, Israel, and a few European countries.

Nushafreens family found Israel as the most affordable option as compared to all other countries offering the treatment. They reached out to Sheba Medical Centre in Israel which estimated the medical expenses as 200,000 USD (approximately Rs 1.5 crore). The treatment will require Nushafreen to be hospitalized for a month or more for the response to treatment and immediate follow up.

As Nushafreens family couldnt afford the high medical expenses, an ImpactGuru crowdfunding campaign was initiated. In two weeks, Nushafreens ImpactGuru.com Page has raised over Rs 1 crore from 1750 donors. The platform raises money online for medical expenses via crowdfunding such as cancer, transplants, and accidents.

According to the co-founder and CEO of the healthcare crowdfunding platform, Piyush Jain, Crowdfunding is driven by a culture of generosity, it allows people to raise money quickly in a hassle free manner without any payback liability. This is a new record for our platform with a single patients family being able to raise more than Rs 1 crore. We hope Nushafreen recovers soon and more patients come forward to utilize our platform in their time of need to get the best available treatment for critical illnesses.

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Crowdfunding to the rescue for this cancer patient - Telangana Today

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DetailsCategory: AntibodiesPublished on Sunday, 02 August 2020 16:34Hits: 344

COPENHAGEN, Denmark I July 31, 2020 I Genmab A/S (Nasdaq: GMAB) announced today that the European Myeloma Network (EMN) in collaboration with Janssen Research & Development, LLC (Janssen) reported positive results from the Phase 3 APOLLO (MMY3013) study of the subcutaneous (SC) formulation of daratumumab in combination with pomalidomide and dexamethasone (Pd) versus Pd alone as treatment for patients with relapsed or refractory multiple myeloma who have previously been treated with lenalidomide (an immunomodulatory drug) and a proteasome inhibitor (PI). The study met the primary endpoint of improving progression-free survival (PFS). Overall, the safety profile of daratumumab SC in combination with Pd was consistent with the safety profile for each therapy separately.

We are pleased with these positive results for daratumumab, administered as a subcutaneous formulation, in combination with pomalidomide and dexamethasone. The corresponding intravenous regimen was previously approved by the U.S. FDA based on the Phase1 single-arm EQUULEUS study, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Janssen Biotech, Inc., which obtained an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab in 2012, intends to discuss the data with health authorities in preparation for regulatory submissions and plans to submit the data for presentation at an upcoming medical conference.

The APOLLO study was designed to confirm the results from the Phase 1 EQUULEUS (MMY1001) study, which investigated intravenous (IV) daratumumab plus Pd in the same indication. In June 2017, the U.S. Food and Drug Administration (U.S. FDA) approved the use of DARZALEX in combination with Pd for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and aPI based on the results of the EQUULEUS study.

About the APOLLO (MMY3013) studyThis Phase 3 (NCT03180736), randomized, open-label, multicenter study included 304 patients with multiple myeloma who have previously been treated with lenalidomide and a PI. Patients were randomized 1:1 to either receive daratumumab in combination with Pd or Pd alone. In the original design of the study, patients in the daratumumab plus Pd arm were treated with the IV formulation of daratumumab. As of Amendment 1, all new subjects in the experimental arm were dosed with the SC formulation of daratumumab and patients who had already begun treatment with IV daratumumab had the option to switch to the SC formulation. The primary endpoint of the study was PFS. The study was conducted in Europe under an agreement between Janssen, EMN and Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON).

About multiple myelomaMultiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,000 new patients were estimated diagnosed with multiple myeloma and approximately 13,650 people were expected to have died from the disease in the U.S. in 2018.3 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About DARZALEX (daratumumab)DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy7. Daratumumab is the first subcutaneous CD38-directed antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.8 DARZALEX FASPRO is the first subcutaneous CD38-directed antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,9,10,11,12

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of three approved antibodies: DARZALEX (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Arzerra (ofatumumab, under agreement with Novartis AG), for the treatment of certain chronic lymphocytic leukemia indications in the U.S., Japan and certain other territories and TEPEZZA (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in the U.S., has been approved in the U.S. and Europe for the treatment of adult patients with certain multiple myeloma indications. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development by Novartis for the treatment of relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

1 American Cancer Society. "Multiple Myeloma Overview." Available at http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma.Accessed June 2016.2 National Cancer Institute. "A Snapshot of Myeloma." Available at http://www.cancer.gov/research/progress/snapshots/myeloma. Accessed June 2016. 3 Globocan 2018. United States of America Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/840-united-states-of-america-fact-sheets.pdf.4 Globocan 2018. World Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed December 2018.5 American Cancer Society. "How is Multiple Myeloma Diagnosed?" http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis. Accessed June 20166 DARZALEX Prescribing information, September 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s024lbl.pdf Last accessed September 20197 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed June 20208 DARZALEX FASPRO Prescribing information, May 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf Last accessed May 20209 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.10 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.11 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.12 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974.

SOURCE: Genmab

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Genmab Announces European Myeloma Network and Janssen Achieve Positive Topline Results from Phase 3 APOLLO Study of Daratumumab in Combination with...

Recommendation and review posted by Bethany Smith

The MSK expert explained that pre- and post-test educatin on genetic testing could help patients and providers alike to better understand the results.

Pre- and post-test education on genetic testing may help patients disseminate information more easily to their health care providers, according to Kelly Morgan, MS, CGC.

In a recent study, presented at the 2020 ASCO Virtual Scientific Program, the BRCA Founder OutReach (BFOR) offered pre-testing online education with posttest engagement of primary care providers, which appeared to be effective in educating both patients and providers alike.

So, in terms of the participant experience, we found satisfaction to be high both after this pre-test education and also after genetic testing. Knowledge was high after the pre-test education, which was very important from our perspective to make sure our participants were able to adequately receive the information they need to make a decision like this, said Morgan, a genetic counselor at Memorial Sloan Kettering Cancer Center.

In an interview with CancerNetwork, Morgan explained how these results can affect health care providers knowledge of genetic testing moving forward.

Transcription:

From our perspective, we really see this model as a way to more effectively disseminate information. So whether that be to patients but also importantly to their doctors. So you're absolutely right in terms of having a multidisciplinary team and the more that we can engage not only a patient, but their community and their providers to build the biggest sort of network of resources we can, I think that's important. And these digital tools I think, can create a centerpiece for patients and their physicians to come together and both learn

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Kelly Morgan, MS, CGC, on Genetic Testing Education Aiding in Disseminating Information - Cancer Network

Recommendation and review posted by Bethany Smith

Genetic testing may be a helpful tool in diagnosing autism and intellectual disability, but published data does not adequately support its use as a standard predictor of antidepressant response, James B. Potash, MD, MPH, said during a session at the virtual 2020 Psych Congress Elevateconference on the role of genetic testing in psychiatry.

There is ample reason to think that genetic variation ought to predict antidepressant response but research has shown mixed results, said Dr. Potash, who is the Henry Phipps Professor, Director and Psychiatrist-in-Chief, at Johns Hopkins Medicine, Baltimore, Maryland, and has been working in the field of genetics of mood disorders for more than 20 years.

Dr. Potash is a member of the American Psychiatric Association Council on Research, which had a task force analyze the issue in recent years. In a systematic review of pharmacogenetic tests of antidepressants, the task force found that the quality of the data provided by the tests on pharmacodynamicshow a drug affects the brainwas low, he said. However, the study, published in The American Journal of Psychiatry, found the tests provided higher-quality data on regarding particular genes related to how a drug is metabolized in the liver.

Their conclusion was at present there are insufficient data to support the widespread use of combinatorial pharmacogenetic testing in clinical practice, although there are clinical situations in which the technology may be informative, particularly in predicting side effects, Dr. Potash explained.

Similarly, an International Society of Psychiatric Genetics committee on genetic testing last year reached the conclusion that evidence to support widespread use of pharmacogenetic tests is inconclusive. But the statement also says when pharmacogenetic testing results are already available, providers are encouraged to integrate this information into their medication selection and dosing decisions, he said.

As for the future direction of genetic testing in psychiatry, Dr. Potash said there is ongoing research into its use in bipolar disorder.

A study involving 2500 people with bipolar disorder, published in Lancet by the International Consortium on Lithium Genetics, found some genetic variations were statistically significantly associated with response to lithium treatment. People with the highest Polygenic Risk Score (PRS) for schizophrenia had the lowest response to lithium treatment, and people with the lowest schizophrenia PRS had the highest response to lithium treatment. In addition, a paper recently published in Molecular Psychiatry found that people with bipolar disorder who had the lowest PRS for depression were 75% more likely to respond favorably to lithium, compared with those with the highest depression PRS scores.

Dr. Potash also spoke about the importance of a more traditional genetic research tool: collecting a detailed family history from a patient.

It has been known for a long time but its not always implemented, he said, noting that familial recurrence risk has been analyzed for more than 100 years.

For example, he explained, if one parent has schizophrenia and no siblings or second-degree relatives do, a child has a 6% risk of developing schizophrenia. But if one parent, two siblings, and a second-degree have the disorder, the relative the risk of a child inheriting it is 36%.

That kind of information is important, he said. Very important. Its valuable.

Terri Airov

References

Amare AT, Schubert KO, Hou L.,et al.Association of polygenic score for major depression with response to lithium in patients with bipolar disorder.Molecular Psychiatry. 2020 March 16;[Epub ahead of print].

Genetic Testing Statement. International Society of Psychiatric Genetics. Accessed July 15, 2020.

Hou L, Heilbronner U, Degenhardt F, et al. Genetic variants associated with response to lithium treatment in bipolar disorder: a genome-wide association study. Lancet. 2016;387(10023):1085-1093.

The role of genetic testing in psychiatry. Presented at Psych Congress Elevate: Virtual; July 26, 2020.

Zeier Z, Carpenter LL, Kalin NH, et al. Clinical implementation of pharmacogenetic decision support tools for antidepressant drug prescribing. The American Journal of Psychiatry. 2018;175:873886.

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The Limitations and Promise of Genetic Testing in Psychiatry - Psych Congress Network

Recommendation and review posted by Bethany Smith

This article was originally published here

J Gen Intern Med. 2020 Jul 27. doi: 10.1007/s11606-020-06064-x. Online ahead of print.

ABSTRACT

BACKGROUND: Prior studies suggest that referral to genetic counseling and completion of genetic testing vary by race/ethnicity; however, the data are limited.

OBJECTIVE: We sought to evaluate patterns of genetic testing and clinical outcomes across race/ethnicity at a hereditary breast and ovarian cancer center.

DESIGN: The medical records for all patients undergoing genetic assessment at a hereditary breast and ovarian cancer center were reviewed and stratified by self-reported race/ethnicity (non-Hispanic White, Hispanic, non-Hispanic Black, and Asian).

PARTICIPANTS: A total of 1666 patients met inclusion criteria (non-Hispanic Whites, 1367; Hispanics, 85, non-Hispanic Blacks, 101; Asians, 113).

MAIN MEASURES: Demographics, patient characteristics, and referral patterns for patients who underwent genetic testing were analyzed using Kruskal-Wallis tests, chi-square test, or Fishers exact tests, stratifying by self-reported race/ethnicity. Pathogenic mutations and variants of unknown significance (VUS) were reviewed. Outcomes of patients with genetic mutations and personal history of breast and/or gynecologic malignancies were compared.

KEY RESULTS: Non-Hispanic Whites were more likely to be referred due to family cancer history compared to all other ethnicities while Non-Hispanic Blacks, Hispanics, and Asians were more likely to be referred due to personal history of cancer (p < 0.001). Non-Hispanic Blacks and Hispanics were more likely to have advanced-stage cancer at the time of genetic testing (p < 0.02). Rates of mutations did not differ by race/ethnicity when Ashkenazi Jewish patients were excluded (p = 0.08). Among patients found to have a BRCA1/2 mutation, Non-Hispanic Whites were more likely to undergo cancer screening and risk-reducing surgery compared with all other ethnicities (p = 0.04).

CONCLUSIONS: Minority patients were more likely to utilize genetic services following a cancer diagnosis and less likely due to family cancer history, suggesting a missed opportunity for mutation detection and cancer prevention in this population. Efforts to eradicate racial/ethnic disparities in early access to genetic testing and guided cancer prevention strategies are essential.

PMID:32720237 | DOI:10.1007/s11606-020-06064-x

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Racial and Ethnic Disparities in Genetic Testing at a Hereditary Breast and Ovarian Cancer Center - DocWire News

Recommendation and review posted by Bethany Smith

The Global At Home Genetic Testing Market Research Report provides customers with a complete analytical study that provides all the details of key players such as company profile, product portfolio, capacity, price, cost, and revenue during the forecast period from 2020 to 2027. The report provides a full assessment. At Home Genetic Testing market with future trends, current growth factors, meticulous opinions, facts, historical data and statistically supported and industry-validated market data.

This At Home Genetic Testing market research provides a clear explanation of how this market will impress growth during the mentioned period. This study report scanned specific data for specific characteristics such as Type, Size, Application and End User. There are basic segments included in the segmentation analysis that are the result of SWOT analysis and PESTEL analysis.

To Learn More About This Report, Request a Sample Copy:https://www.worldwidemarketreports.com/sample/339093* The sample copy includes: Report Summary, Table of Contents, Segmentation, Competitive Landscape, Report Structure, Methodology.

23andMe, MyHeritage, LabCorp, Myriad Genetics, Ancestry.com, Quest Diagnostics, Gene By Gene, DNA Diagnostics Center, Invitae, IntelliGenetics, Ambry Genetics, Living DNA, EasyDNA, Pathway Genomics, Centrillion Technology, Xcode, Color Genomics, Anglia DNA Services, African Ancestry, Canadian DNA Services, DNA Family Check, Alpha Biolaboratories, Test Me DNA, 23 Mofang, Genetic Health, DNA Services of America, Shuwen Health Sciences, Mapmygenome, Full Genomes are some of the major organizations dominating the global market.(*Note: Other Players Can be Added per Request)

Key players in the At Home Genetic Testing market were identified through a second survey, and their market share was determined through a primary and second survey. All measurement sharing, splitting, and analysis were solved using a secondary source and a validated primary source. The At Home Genetic Testing market report starts with a basic overview of the Industry Life Cycle, Definitions, Classifications, Applications, and Industry Chain Structure, and when used together, how key players can meet market coverage, offered characteristics, and customer needs It helps to understand.

The report also makes some important suggestions for new At Home Genetic Testing market projects before evaluating their feasibility. Overall, this report covers At Home Genetic Testing market Sales, Price, Sales, Gross Profit, Historical Growth,and Future Prospects. It provides facts related to the widespread merger, acquisition, partnership, and joint venture activities on the market.

This report includes market size estimates of value (million US $) and trading volume (K MT). The top-down and bottom-up approaches are used to estimate and validate the market size of the At Home Genetic Testing market, estimating the size of various other subordinate markets in the overall market. All ratio sharing, splitting, and analysis were determined using the secondary source and the identified primary source.

What At Home Genetic Testing Market report offers:

Remarkable Attributes of At Home Genetic Testing Market Report:

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At Home Genetic Testing Market: an Increase in Revenue That Will Change the Game After COVID 19: 23andMe, MyHeritage, LabCorp - Market Research Posts

Recommendation and review posted by Bethany Smith

By Dr. Lynn Webster, PNN Columnist

Millions of Americans order DNA test kits to determine their ancestries. Knowing where you come from can be entertaining. However, DNA testing can also help identify your risk of developing some diseases, including chronic pain.

Prenatal testing for genetic disorders is common. But genetic testing is also increasingly used to determine the risk of developing certain diseases or potential responses to specific drugs.

Currently, little is known about how to use genes to make an individual more or less sensitive to pain, or to learn the likelihood that someone will respond in a particular way to an analgesic based on their genetics. The good news is that we are on the cusp of gaining more information about the genes that control pain and pain treatments, and that knowledge should allow us to develop targeted pain therapies.

Most physicians still believe that everyone experiences pain in the same way. Research recently published in Current Biology discovered a genethe so-called "Neanderthal gene"that is associated with increased sensitivity to pain. Recognizing that a mutation of a specific gene can influence pain perception may be illuminating for many members of the medical profession.

Pain specialists have known for a long time that given the same stimulus, some people feel more pain than others. The truth is, there are several genes besides the Neanderthal gene that determine how an individual experiences pain. Some genes increase our sensitivity to pain, while other genes decrease it. Some genes influence how pain is processed, while other genes determine an individual's response to an analgesic.

The ability for an analgesic to provide pain relief in an individual is partially determined by the genetics of the receptor to which the pain medication binds. These genes are different from pain-sensitivity genes. For example, oxycodone may be very effective in relieving pain for one individual, but only partially effective for another.

Optimal pain relief requires recognition that each individual responds uniquely to a given analgesic. Doctors are beginning to provide gene therapy for cancer patients. Advancements in research may someday allow us to do the same for patients with pain.

The array of pain responses to the same stimulus is a major reason why one-size-fits-all dosing of pain medications is flawed. A given dose may leave some patients undertreated and others over-treated. Unfortunately, regulators who set arbitrary dose limits fail to understand or consider this biologic variability.

Differing clinical responses to pain stimuli and medications underscore the need to individualize therapy. Knowing more about the biology of pain can help us to understand each individuals response to painful stimuli and the variable response to any therapy.

How we experience pain is a result of both environmental and genetic features. The genetic factors are what we inherit. Environmental factors which we develop rather than inherit include cultural attitudes, emotions, and individual responses to stress. Our personality and lifes experiences are included in the environmental factors that contribute to our experience of pain. Therefore, pain is a result of genetic and environmental interactions. Both can make an individual more or less sensitive to stimuli or analgesia. It is a complex and dynamic process.

The so-called Neanderthal gene is not a new discovery but was newly recognized in Neanderthals. The discovery is interesting, because it implies the gene has an evolutionary purpose. The gene is known as SCN9. There are several pain syndromes associated with the genetic mutations of the SCN9 gene, including some types of back pain and sciatica. Mutations of this gene can result in the total absence of pain or a heightened pain expression. The type of mutation determines the phenotype (or personal characteristics) of our response to a painful stimulus.

It is unclear how Neanderthals benefited biologically from increased pain sensitivity. As we know, acute pain elicits an alarm and is considered protective. It teaches us to avoid dangers that can threaten our life, and prevents us from walking on a broken leg until it heals sufficiently to bear our weight.

Evolution may not have been concerned about the effects of chronic pain. The Neanderthals' limited life expectancy, and the fact that their survival depended on strong physical conditioning, may have made chronic pain a non-issue. Chronic pain may have made survival difficult, or even impossible, for the Neanderthals.

The recent discovery that Neanderthals had the SCN9 gene should not be surprising, given the fact that modern humans shared a common ancestor with Neanderthals. The Neanderthal gene study is of particular interest to me, because I am working with several companies that are exploring potential drugs to affect the function of the SCN9 gene. The companies have different approaches, but they all are trying to find a way to dial down an individual's sensitivity to painful stimuli.

Since the SCN9 gene can be responsible for the total absence of all pain, as well as several extreme forms of pain, it may be reasonable to target the SCN9 gene to modulate pain.

My hope is that manipulation of the SCN9 gene will reduce pain sensitivity, making it easier to control pain by adjusting the dose and type of drug we prescribe.

It is possible one or more drugs that target the SCN9 gene will be available within the next 4-6 years. If that occurs, it could be game changer for people in pain. We can then thank our Neanderthal ancestors for the evolutionary gift.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, The Painful Truth, and co-producer of the documentary, It Hurts Until You Die. You can find Lynn on Twitter: @LynnRWebsterMD

Continue reading here:
Genetic Studies Could Pave the Way to New Pain Treatments - Pain News Network

Recommendation and review posted by Bethany Smith

The Europe Genetic Testing Market report 2020 covers all the significant developments which are recently being adopted across the global market. The prime objective of the Europe Genetic Testing market report is to provides an in-depth analysis of all market dynamics including drivers and restraints, and trends, and opportunities. The Europe Genetic Testing market report covers both the demand and supply aspects of the market. The report also highlighted the future trends in the Europe Genetic Testing market that will impact the demand during the forecast period.

Scope of the Report:

As per the scope of this report, genetic testing is a test performed to identify the presence of a particular gene/s with a particular sequence of the genome. The gene/s can be identified either directly through sequencing or indirectly through various methods.

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Market Overview:

Some of the Top Key Players of Europe Genetic Testing Market Report Are:

Report Highlights:

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Key Market Trends:

Diagnostic testing is the segment under type of testing that is expected to grow fastest during the forecast period

Predictive and presymptomatic testing dominated the European genetic testing market system, as it is utilized for the detection of gene mutations related to disorders that appear after birth, frequently in later stages of life. Such tests can be of assistance to individuals having a family member with a genetic disorder, though they are free of any features of the disorder while testing.

Diagnostics testing is expected to register a CAGR of 14.29%, as it is used to diagnose or rule out a specific genetic condition. In most cases, genetic testing is used to confirm a diagnosis when a particular condition is suspected based on physical mutations and symptoms. Furthermore, companies, such as Centogene and NIMGenetics, offer a wide range of genetic diagnostic services in Europe, which is further accelerating the growth of the market.

The Report Covers:

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Detailed TOC of Europe Genetic Testing Market Report 2020-2024:

1 INTRODUCTION1.1 Study Deliverables1.2 Study Assumptions1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS4.1 Market Overview4.2 Market Drivers4.2.1 Increasing Emphasis on Early Disease Detection and Prevention4.2.2 Increasing Demand for Personalized Medicine4.2.3 Increasing Application of Genetic Testing in Oncology4.3 Market Restraints4.3.1 High Costs of Genetic Testing4.3.2 Social and Ethical Implications of Genetic Testing4.4 Porters Five Forces Analysis4.4.1 Threat of New Entrants4.4.2 Bargaining Power of Buyers/Consumers4.4.3 Bargaining Power of Suppliers4.4.4 Threat of Substitute Products4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION5.1 Type5.1.1 Carrier Testing5.1.2 Diagnostic Testing5.1.3 Newborn Screening5.1.4 Predictive and Presymptomatic Testing5.1.5 Prenatal Testing5.1.6 Nutrigenomic Testing5.2 Disease5.2.1 Alzheimers Disease5.2.2 Cancer5.2.3 Cystic Fibrosis5.2.4 Sickle Cell Anemia5.2.5 Duchenne Muscular Dystrophy5.2.6 Thalassemia5.2.7 Huntingtons Disease5.2.8 Special Disease5.2.9 Other Diseases5.3 Technology5.3.1 Cytogenetic Testing5.3.2 Biochemical Testing5.3.3 Molecular Testing5.4 Geography5.4.1 Europe5.4.1.1 Germany5.4.1.2 United Kingdom5.4.1.3 France5.4.1.4 Italy5.4.1.5 Spain5.4.1.6 Rest of Europe

6 COMPETITIVE LANDSCAPE6.1 Company Profiles6.1.1 Illumina Inc.6.1.2 Abbott Laboratories6.1.3 23andMe Inc.6.1.4 F. Hoffmann-La Roche Ltd6.1.5 Qiagen6.1.6 Blueprint Genetics Oy6.1.7 Eurofins Scientific6.1.8 Centogene AG6.1.9 Thermo Fisher Scientific6.1.10 Elitech Group

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

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Europe Genetic Testing Market 2020 | Research Objectives and Methodology, Growth Analysis, Top Manufacturers Sales, and Cost Structures Forecast 2024...

Recommendation and review posted by Bethany Smith

A 23andMe Inc. DNA genetic testing kit.

Photographer: Cayce Clifford/Bloomberg

Photographer: Cayce Clifford/Bloomberg

U.K. drugmaker GlaxoSmithKline Plc and genetic-testing giant 23andMe Inc. have begun their first joint human clinical trial as part of a collaboration to leverage the Silicon Valley firms DNA database to develop drugs.

The companies said that they enrolled their first patientthis month in early-stage trials for a drug that targets human tumors. The drug is an antibody that works to block CD96, a proteinthat plays a role in modulating the bodys immune responses. The theory is that blocking it will help control the activity of another molecule in the body called CD155 that is often over-expressed in malignant human tumors.

GSK took a $300 million stake in 23andMe in 2018in a deal to share its data and collaborate on drug development.The idea was to comb DNA data and health information volunteered by 23andMes more than 12 million customersto hunt for clues as to the role genetics playin different diseases and then translate those insights into potential new drugs.

This is a new way of thinking about drug development, Hal Barron, GSKs chief scientific officer and president of research and development, said in an interview. And the concept is coming to bear.

There is much enthusiasm in the pharmaceutical world for the pathway that these companies are targeting. Prior to teaming up, both had their own programs to explore CD96. 23ndMe tapped into its database to validate GSKs approach, using an algorithm that compared potential drug targets to a data set that included genetic information along with other health data shared by customers in order to identify genetic patterns.

Its an important target, Barron said. Hopefully well find out in the clinic that it helps patients fight cancer, and maybe even aids the immune system in eradicating it. That would be the ideal situation.

The two companies have nearly 30 programs underway exploring potential drug targetsin oncology, immunology, neurology, cardiovascular and metabolic disease. The vast majority are still in the early stages of validating those molecular pathways; for a few, drug discovery efforts are already underway.

What has surprised me the most is how well this approach has worked, how productive its been, said 23andMe Chief Executive Officer Anne Wojcicki.

Identifying a molecular pathway that plays a role in a disease is only part of the hurdle in developing a drug. Even once its clear that a target is involved in a disease, altering it could have other negative health impacts or simply be difficult to design a drug due to the intricacies of human biology.

While its unlikely all thosewill make it to clinical trials, Barron said thatusing genetics to find potential drug targets will hopefully lead to a higher probability thoseultimately result in effective medicines.

23andMe launched its therapeutics program five years ago, and its become an increasingly large focus of the company. In January, it licensed an antibody it had developed to treat inflammatory diseases to Spanish drugmaker Almirall SA. The company is individually pursuing other drug candidates, some of which it may put through clinical trials itself rather than licensing out to other companies.

Before it's here, it's on the Bloomberg Terminal.

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23andMe and GSK Head to Clinical Trials With Cancer Drug - Bloomberg

Recommendation and review posted by Bethany Smith

Exercise can help prevent excess fatigue for survivors of cancer and other issues are explored in this summer issue of CURE.

Unlike tiredness from a hard day at work or a vigorous workout, cancer fatigue can be unrelated to a persons activities yet all encompassing. The phenomenon can be difficult for those who have never had cancer to understand.

(Friends) really do not get it when I need to go home and climb into bed immediately or am unable to take one more step or have to cancel an engagement, Jane Biehl, a CURE Voices contributor, wrote in a May 15 blog. Before cancer, willpower carried me through fatigue, but no more. That weight all over my body frankly kicks my butt.

In this issue of CURE, we take an in-depth look at cancer fatigue, its causes and a variety of treatment options. Perhaps counterintuitively, experts point out that the most effective therapy for this condition is exercise, a remedy that could seem daunting. Research consistently supports this idea, and our article describes the kinds of programs that work best.

In another feature, we tackle the topic of radiopharmaceuticals, radioactive drugs with an expanding role in both treatment and diagnosis. The expectation is that more of these drugs will be discovered over the next decade, and additional uses will be found for those already on the market. Our article discusses the fascinating area called theranostics or using the same radiopharmaceutical to both diagnose and treat a specific cancer.

Elsewhere in the treatment arena, we bring highlights from Junes annual meeting of the American Society of Clinical Oncology, including findings in colorectal, bladder, ovarian and non-small cell lung cancers. This issue also covers investigational treatments for chronic lymphocytic leukemia and kidney cancer.

At the other end of the spectrum, we look at the time before cancer develops and how people can protect themselves. With the help of a Northwestern University expert in epidemiology and cancer prevention, we examine recommended strategies for avoiding the disease. A separate piece explores whether those who had genetic testing years ago should repeat the process using todays more sophisticated tests to get a more comprehensive picture of whether they have any inherited cancer-causing genes.

Finally, we come full circle with another article on easing a side effect, in this case hair loss during chemotherapy. In an interview, an oncology expert answers our questions about the safety, effectiveness and availability of cold caps.

We hope that these articles, which span the cancer journey from prevention to survivorship, leave you better informed about strategies that can help you lead a healthier and more comfortable life. As always, thank you for reading.

Original post:
Exercise Can Help Ease Excessive Fatigue in Survivors of Cancer - Curetoday.com

Recommendation and review posted by Bethany Smith

In its recently published report, Report Ocean has provided unique insights about the Direct-To-Consumer (DTC) Genetic Testing Market. The main objectives of this research report is to categorize the various dynamics of the market and to offer latest updates such as mergers and acquisitions, various technological developments, new entrants in the market, which make an impact on different segments of the Direct-To-Consumer (DTC) Genetic Testing Market.

This research report offers in-depth study about Market Size and Share, Product and Services, Company Profile, Regional Forecast, Consumer Preference, Market Competition, and Industry Chain Structure.

This research report represents the statistical data in the form of TABLES, CHARTS, and infographics to assess the market, its growth and development, and market trends of the Direct-To-Consumer (DTC) Genetic Testing Market during the forecasted period.

COVID 19 Impact on Direct-To-Consumer (DTC) Genetic Testing Market

The Coronavirus Pandemic (COVID-19) has affected every aspect of life worldwide. Under COVID-19 Outbreak, how the Direct-To-Consumer (DTC) Genetic Testing Market will develop is also analyzed in detail in Chapter 1.7 of the report.

In Chapter 2.4, we analyzed industry trends in the context of COVID-19.

In Chapter 3.5, we analyzed the impact of COVID-19 on the product industry chain based on the upstream and downstream markets.

In Chapters 6 to 10 of the report, we analyze the impact of COVID-19 on various regions and major countries.

In chapter 13.5, the impact of COVID-19 on the future development of the industry is pointed out.

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Competitive Landscape:

Key players in the global Direct-To-Consumer (DTC) Genetic Testing market covered in Chapter 4:Myriad GeneticsMD RevolutionDeCODEme23andMeGenetrainerGeneByGeneDNA DTCGenecodebook OyNavigenicsThis report also outlines the Major companies or players involved in the Direct-To-Consumer (DTC) Genetic Testing Market, along with product specifications, revenue generated, pricing strategies, contact information, information related to raw materials, equipment and demands. With the help of tables and figures, valuable insights on production, value, price, and gross margin of each player are offered.

Market Segmentation:

The segmentation study is considered as the key section to decide the target market with keen study of segments or smaller sections such as geographical regions, application and product type to optimize advertising technique and marketing strategies at regional as well as global level of the Direct-To-Consumer (DTC) Genetic Testing Market.

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2020-2026) of the following regions are covered in Chapter 5, 6, 7, 8, 9, 10, 13:

North America (Covered in Chapter 6 and 13)

United States

Canada

Mexico

Europe (Covered in Chapter 7 and 13)

Germany

UK

France

Italy

Spain

Russia

Others

Asia-Pacific (Covered in Chapter 8 and 13)

China

Japan

South Korea

Australia

India

Southeast Asia

Others

Middle East and Africa (Covered in Chapter 9 and 13)

Saudi Arabia

UAE

Egypt

Nigeria

South Africa

Others

South America (Covered in Chapter 10 and 13)

Brazil

Argentina

Columbia

Chile

Others

Some of the Major Highlights of TOC covers:

Report Overview

Study Scope

Key Market Segments

Regulatory Scenario by Region/Country

Market Investment Scenario Strategic

Global Market Growth Trends

Industry Trends

SWOT Analysis

Porters Five Forces Analysis

Potential Market and Growth Potential Analysis

Industry News and Policies by Regions

Industry News

Industry Policies

Industry Trends Under COVID-19

Value Chain of Direct-To-Consumer (DTC) Genetic Testing Market

Value Chain Status

Direct-To-Consumer (DTC) Genetic Testing Market Manufacturing Cost Structure Analysis

Production Process Analysis

Manufacturing Cost Structure of Direct-To-Consumer (DTC) Genetic Testing Market

Labor Cost of Direct-To-Consumer (DTC) Genetic Testing Market

Labor Cost of Direct-To-Consumer (DTC) Genetic Testing Market Under COVID-19

Sales and Marketing Model Analysis

Downstream Major Customer Analysis (by Region)

Value Chain Status Under COVID-19

Direct-To-Consumer (DTC) Genetic Testing Market Production, Revenue (Value), Price Trend by Type

Production and Market Share by Type

Revenue and Market Share by Type

Price by Type

Direct-To-Consumer (DTC) Genetic Testing Market Production, Consumption, Export, Import by Region

Production, Consumption, Export, Import by Region

Production, Consumption, Export, Import by Country

Production, Revenue, Price and Gross Margin

Industrial Chain, Sourcing Strategy and Downstream Buyers

Direct-To-Consumer (DTC) Genetic Testing Market Industrial Chain Analysis

Raw Materials Sources of Direct-To-Consumer (DTC) Genetic Testing Market major Players in 2019

Downstream Buyers

Direct-To-Consumer (DTC) Genetic Testing Market Forecast

Direct-To-Consumer (DTC) Genetic Testing Market Sales, Revenue and Growth Rate

Direct-To-Consumer (DTC) Genetic Testing Market Production, Consumption, Export and Import Forecast by Region

Direct-To-Consumer (DTC) Genetic Testing Market Production, Revenue and Price Forecast by Type

Direct-To-Consumer (DTC) Genetic Testing Market Consumption Forecast by Application

Direct-To-Consumer (DTC) Genetic Testing Market Forecast Under COVID-19

Years considered for this report:

Historical Years: 2015-2019

Base Year: 2019

Estimated Year: 2020

Forecast Period: 2020-2026

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COVID-19 Impact on Direct-To-Consumer (DTC) Genetic Testing Market 2020- future development, manufacturers, trends, share, size and forecast details...

Recommendation and review posted by Bethany Smith

SALT LAKE CITY, July 29, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced today that the company has launched its proprietary AMPLIFY technology, which further increases the performance of its Prequelnoninvasive prenatal screening (NIPS) test. The proprietary AMPLIFY process increases the fetal fraction of a NIPS sample by preferentially sequencing the fetal cell-free DNA fragments that circulate in a mothers blood. AMPLIFY technology enables more accurate detection of fetal chromosome abnormalities. In the analytical validation involving samples from more than 1,000 pregnant women, fetal fraction is 2.3 times greater on average with AMPLIFY than with standard NIPS. This improvement reduces false positive and false negative resultsincluding for common aneuploidies, expanded aneuploidies, microdeletions and a babys sex. For instance, false negative performance in common aneuploidies improves 45x with AMPLIFY technology. Additionally, no samples powered by AMPLIFY technology had a fetal fraction below four percent. Other laboratories may fail samples with less than four percent fetal fraction.

Prequel already provided highly accurate results and this proprietary technology further increases the sensitivity of our test, said Nicole Lambert, president of Myriad International, Oncology and Womens Health. With AMPLIFY, Prequel maintains an industry-leading low rate of failed samplesdelivering results to 99.9 percent of patients. The important clinical benefits are that each woman who receives the test can expect highly accurate NIPS results, regardless of body mass index (BMI), race, or ethnicity.

Up to 50 percent of pregnant women present with high BMI to their healthcare provider. Studies have demonstrated that BMI is not evenly distributed across ethnicities, and up to 24 percent of women with high BMI will not receive a result on standard NIPS platforms due to low fetal fraction. Women who dont receive a result may do no further prenatal screening at all; they may go through subsequent rounds of NIPS, or they may undergo invasive procedures such as an amniocentesis or chorionic villus sampling, which can increase the risk of miscarriage and add unnecessary expense to the US healthcare system. Prequel with AMPLIFY technology overcomes the limitations of standard NIPS in order to provide equity of care to pregnant women.

About Prequel Prenatal ScreenThe Myriad Prequel Prenatal Screen is a non-invasive prenatal screen (NIPS) that uses cell-free DNA (cfDNA) to determine if a pregnancy is at an increased risk for chromosome abnormalities, such as Down syndrome. Compared to screening methods which use maternal age, ultrasound and serum screening, Prequel has been shown to be superior than by achieving a lower false-positive rate and false-negative rate than these other methods. Among other NIPS, Prequel has an industry leading test failure rate of 0.1 percent. The Prequel Prenatal Screen can be ordered with the Foresight Carrier Screen and offered to all women, including those with high body mass index, and ovum donor or a twin pregnancy.

About Myriad GeneticsMyriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to launch of the Companys proprietary AMPLIFY technology; and the Companys strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Assn for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Intl, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2019, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

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Myriad Launches Proprietary AMPLIFY Technology, Further Increasing the Performance of its Prequel NIPS Test - GlobeNewswire

Recommendation and review posted by Bethany Smith

Insights on the Global Stem Cell-Derived Cells Market

PMR is one of the leading market research companies in India. Our team of research analysts have a deep understanding and knowledge related to the latest market research techniques and use their analytical skills to curate insightful and high-quality market reports. The presented data is collected from credible primary sources including marketing heads, sales managers, product managers, industry experts, and more.

As per the report, the global Stem Cell-Derived Cells market reached a value of ~US$ XX in 2018 and is likely to surpass a market value of ~US$XX by the end of 2029. Further, the report reveals that the Stem Cell-Derived Cells market is set to grow at a CAGR of ~XX% during the forecast period (2019-2029)

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Critical doubts related to the Stem Cell-Derived Cells market addressed in the report:

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Segmentation of the Stem Cell-Derived Cells market

The report bifurcates the Stem Cell-Derived Cells market into different segments to provide a clear understanding of the various aspects of the market.

Regional Outlook

The regional outlook section of the report includes vital data such as the current trends, regulatory framework, The Stem Cell-Derived Cells market study offers critical data including, the sales volume, sales growth, and pricing analysis of the different products in the Stem Cell-Derived Cells market.

key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.

The increasing approval for new stem cell-derived cells by the FDA across the globe is projected to propel stem cell-derived cells market revenue growth over the forecast years. With low entry barriers, a rise in number of companies has been registered that specializes in offering high end quality human tissue for research purpose to obtain human induced pluripotent stem cells (iPS) derived cells. The increase in product commercialization activities for stem cell-derived cells by leading manufacturers such as Takara Bio Inc. With the increasing rise in development of stem cell based therapies, the number of stem cell-derived cells under development or due for FDA approval is anticipated to increase, thereby estimating to be the most prominent factor driving the growth of stem cell-derived cells market. However, high costs associated with the development of stem cell-derived cells using complete culture systems is restraining the revenue growth in stem cell-derived cells market.

The global Stem cell-derived cells market is segmented on basis of product type, material type, application type, end user and geographic region:

Segmentation by Product Type

Segmentation by End User

The stem cell-derived cells market is categorized based on product type and end user. Based on product type, the stem cell-derived cells are classified into two major types stem cell-derived cell kits and accessories. Among these stem cell-derived cell kits, stem cell-derived hepatocytes kits are the most preferred stem cell-derived cells product type. On the basis of product type, stem cell-derived cardiomyocytes kits segment is projected to expand its growth at a significant CAGR over the forecast years on the account of more demand from the end use segments. However, the stem cell-derived definitive endoderm cell kits segment is projected to remain the second most lucrative revenue share segment in stem cell-derived cells market. Biotechnology and pharmaceutical companies followed by research and academic institutions is expected to register substantial revenue growth rate during the forecast period.

North America and Europe cumulatively are projected to remain most lucrative regions and register significant market revenue share in global stem cell-derived cells market due to the increased patient pool in the regions with increasing adoption for stem cell based therapies. The launch of new stem cell-derived cells kits and accessories on FDA approval for the U.S. market allows North America to capture significant revenue share in stem cell-derived cells market. Asian countries due to strong funding in research and development are entirely focused on production of stem cell-derived cells thereby aiding South Asian and East Asian countries to grow at a robust CAGR over the forecast period.

Some of the major key manufacturers involved in global stem cell-derived cells market are Takara Bio Inc., Viacyte, Inc. and others.

The report covers exhaustive analysis on:

Regional analysis includes

Report Highlights:

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Important insights present in the report:

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Stem Cell-Derived Cells Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2019 2029 - Bulletin Line

Recommendation and review posted by Bethany Smith