Application of ImmTORplus IGANs IgA protease to targetimmunoglobulin A (IgA) deposition, the critical event leading to IgA Nephropathy (IgAN)

Selectas IgA nephropathy program builds upon SEL-212, which has demonstrated ImmTOReffective at tolerizing a highly immunogenic therapeutic enzyme

Investigational New Drug (IND) application expected in Q4 2021

WATERTOWN, Mass., and BOSTON, Oct. 08, 2020 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc.(NASDAQ: SELB) and IGAN Biosciences, Inc. today announced that they have entered into a Research License and Option agreement to study Selectas ImmTORimmune tolerance platform in combination with IGANs immunoglobulin A (IgA) protease for the treatment of IgA Nephropathy (IgAN). In advance of exercising its option to enter into an exclusive license agreement, Selecta will conduct preclinical research to evaluate the utility of the combination of ImmTOR and IGANs IgA protease.

Previous studies in animal models conducted at independent laboratories established the ability of IGANs IgA protease to remove injurious IgA from kidneys and improve markers of renal dysfunction. These results suggest that it is an excellent candidate to decrease the rate of disease progression and possibly even reverse the disease. The barrier to IgA protease commercialization is the bacterial origin of the protease, which makes it immunogenic. Selectas proprietary immune tolerance platform, ImmTOR, has shown in clinical studies the ability to mitigate the formation of anti-drug antibodies (ADAs) to immunogenic enzymes. This has been demonstrated with its phase 3 lead product candidate, SEL-212, which is a combination of ImmTOR and pegadricase, an immunogenic proprietary pegylated uricase for the treatment of chronic refractory gout. Selecta and IGAN intend to combine IGANs IgA protease with Selectas ImmTOR platform to develop a novel combination product to treat IgA nephropathy, a disease with significant unmet medical need.

We are excited to build on our learnings from SEL-212 in combining an immunogenic enzyme with our ImmTOR platform to develop a product candidate for IgA nephropathy, said Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta Biosciences. IGANs IgA protease has shown tremendous promise in preclinical studies and combining it with ImmTOR to prevent ADAs could lead to a transformational product for patients with this debilitating disease.

IGAN is pleased to enter into this agreement with Selecta Biosciences to use their ImmTOR technology with IgA proteases as biological therapy for IgA nephropathy, said Andrew G. Plaut, M.D., Co-Founder and Chief Medical Officer of IGAN Biosciences Inc. In combination, these products offer the prospect of realizing the potential value of IgA proteases to remove kidney IgA deposits, thus reducing progression of renal injury to renal failure.

IgA Nephropathy is characterized by deposition of galactose-deficient IgA1 immunoglobulin in the glomerular mesangium and is a leading contributor to development of chronic kidney disease and renal failure. Genetic or environmental causes that form this abnormal IgA1 and its accumulation in the kidney can result in the development of IgAN. Hypertension, proteinuria and decreased eGFR at the time of diagnosis are associated with poor prognosis. It can result in incremental loss of renal function and results in end stage renal disease (ESRD) in approximately 30 - 40% of patients. There are no approved therapies for the treatment of IgAN.

Under the terms of the research license and option agreement, Selecta will make an initial payment to IGAN. If Selecta exercises its option to enter into an exclusive license agreement, IGAN will receive an additional payment and will be eligible for additional development, regulatory, and commercial milestone payments, as well as tiered royalties on net product sales.

AboutSelecta Biosciences, Inc.Selecta Biosciences Inc. (NASDAQ: SELB) is leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses. With a proven ability to induce tolerance to highly immunogenic proteins, ImmTOR has the potential to amplify the efficacy of biologic therapies, including redosing of life-saving gene therapies, as well as restore the bodys natural self-tolerance in autoimmune diseases. The companys first program aimed at addressing immunogenicity to AAV gene therapies is expected to enter clinical trials in early 2021 in partnership with AskBio for the treatment of methylmalonic acidemia (MMA), a rare metabolic disorder. A wholly-owned program focused on addressing IgA nephropathy driven by ImmTOR and a therapeutic enzyme is also in development among additional product candidates. Selecta recently licensed its Phase 3 clinical product candidate, SEL-212, in chronic refractory gout to Sobi. For more information, please visit http://www.selectabio.com.

About IGAN BiosciencesIGAN Biosciencesis a private biotechnology company advancing IgA protease treatment for IgA deposition diseases. Its founders discovered and characterized IgA proteases during more than forty years of research conducted at Tufts University School of Medicine and Tufts Medical Center, Boston, MA.

Selecta Forward-Looking Statements

This press release, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Selectas plan to participate in upcoming investor conferences. All such forward-looking statements are based on managements 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 such forward-looking statements. Such risks and uncertainties include but are not limited to the companys plans to exercise its option to enter into a licensing agreement, preclinical research and development activities related to IGANs IgA Protease, the ability of the IgA Protease to remove injurious IgA from kidneys and improve markers of renal dysfunction, the companys plans to develop a product candidate to treat IgA Nephropathy or other autoimmune indications, the material impact, if any, of the COVID-19 outbreak on the Companys operations, including supply chain and clinical trials, other COVID-19 related risks and those set forth in the Risk Factors section of Selectas Quarterly Report on Form 10-Q filed with theSecurities and Exchange Commission, orSEC, for the quarter endedMarch 31, 2020, and in other filings thatSelectamakes with theSEC. In addition, any forward-looking statements included in this press release represent Selectas views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date.Selectaspecifically disclaims any obligation to update any forward-looking statements included in this press release.

For more information please contact:

Selecta:

For Investors:Lee M. SternSolebury Trout+1-646-378-2922lstern@soleburytrout.com

For Media: Meredith Sosulski, Ph.D.LifeSci Communications, LLC+1-929-469-3851msosulski@lifescicomms.com

IGAN Biosciences:Donald CollinsIronwood Investment Management+1-617-757-7620dcollins@ironwoodfunds.com

Read the original:
Selecta Biosciences and IGAN Biosciences Enter into Research License and Option Agreement to Study Selecta's ImmTOR Immune Tolerance Platform in...

Comments are closed.