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Data Highlights In Vivo Research and the Potential Mechanism of Action in Pancreatic and Prostate Cancers

CARLSBAD, Calif., April 12, 2022 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today highlights three posters presented during the American Association of Cancer Research (AACR) held in New Orleans from April 8-13, 2022.

Qualigen Chairman and CEO Michael Poirier commented, Our lead therapeutic program QN-302 may have the potential to ultimately treat multiple tumor types that are characterized by genomic quadruplexes (G4) which are overrepresented in numerous cancer-related genes. The findings reported in these posters illustrate promising in vivo anti-proliferative activity against pancreatic cancer and metastatic prostate cancer. We are encouraged by the results of these studies as we progress toward our goal to benefit the lives of cancer patients, and are on-track to initiate IND-enabling studies.

Pancreatic cancer remains a high unmet medical need with limited treatment options. According to the American Cancer Society, about 62,210 will be diagnosed with pancreatic cancer in the United States. in 2022, and more than 49,830 patients will die from the disease -- the highest mortality rate of all major cancers. For advanced disease, chemotherapy (sometimes along with a targeted drug therapy) may lengthen survival.1

Poster 2926, Structure-based design of quadruplex-binding small molecule compounds: The essential role of water molecules (Dr. Stephen Neidle) Crystal structures and computer modelling were utilized to characterize the details of the interactions of substituted naphthalene diimides targeted against human DNA quadruplexes, and in particular the role of water molecules in the binding site. It is concluded that information on conserved water molecules is important for drug design and has been used in the design of a current lead compound QN-302.

1 https://pancreatic.org/pancreatic-cancer/pancreatic-cancer-facts/

VIEW AACR POSTER

Session Category: ChemistrySession Title: Structural and Chemical BiologySession Date and Time: Tuesday Apr 12, 2022 9:00 AM - 12:30 PMLocation: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 40

Poster 4068, The potent quadruplex-binding compound QN-302 shows potent anti-proliferative activity in a prostate cancer cell panel and anti-tumor activity in anin vivomodel of metastatic prostate cancer (Dr. Stephen Neidle) demonstrated bioavailability and toleration at therapeutic doses in a prostate cancer cell line, PC3, which is derived from castration-resistant prostate cancer and is therefore relevant to the situation when hormone therapies are no longer effective. The in vivo study, which included the commonly used drug abiraterone, showed that QN-302 had statistically significant anti-tumor activity in this model (p=0.0008) relative to the controls, and was superior to abiraterone.VIEW AACR POSTER

Session Category: Experimental and Molecular TherapeuticsSession Title: New Chemotherapy AgentsSession Date and Time: Wednesday Apr 13, 2022 9:00 AM - 12:30 PMLocation: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 27

Poster 4069, The potent quadruplex-binding compound QN-302 shows anti-tumor activity in patient-derived in vivo models of pancreatic cancer (Dr. Stephen Neidle) outlined a study in which QN-302 displayed substantial anti-tumor activity in three patient-derived xenograft (PDX) models for pancreatic ductal adenocarcinoma (PDAC). Immunocompromised mice were subcutaneously implanted with PDX tumor fragments. Mice intravenously received either QN-302, a vehicle, or in some models, gemcitabine. In three of these models, significant changes in tumor growth were observed in those that received QN-302, together with good tolerance and bioavailability at therapeutic doses.

VIEW AACR POSTER

Session Category: Experimental and Molecular TherapeuticsSession Title: New Chemotherapy AgentsSession Date and Time: Wednesday Apr 13, 2022 9:00 AM - 12:30 PMLocation: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 27

QN-302 is the Companys genomic quadruplex (G4)-selective transcription inhibitor being developed as a potential treatment for PDAC, in addition to other tumors of high unmet clinical need. The abstracts accepted by AACR outline the potential binding to a quadruplex target for the compound, as well as significant anti-tumor activity in relevant animal models.

The AACR Conference, being held in New Orleans from April 8-13, 2022, is a focal point of the scientific cancer community where scientists, clinicians, other health care professionals, survivors, and patients review the latest advances in cancer science and medicine.

About Qualigen Therapeutics, Inc.

Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for adult and pediatric cancer, as well as maintaining and expanding its core FDA-cleared FastPack System, which has been used successfully in diagnostics for over 20 years. Our investigational QN-302 compound is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing the G4s against unwinding, help inhibit cancer cell proliferation. Our investigational QN-247 compound inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells; QN-247 may thereby be able to inhibit the cells proliferation. QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (AML). The investigational compounds within Qualigens RAS-F family of RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. In addition to its oncology drug pipeline, Qualigen has an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid blood testing systems to physician offices and small hospitals for the management of prostate cancer and other diseases and health conditions.

For more information about Qualigen Therapeutics, Inc., please visit http://www.qualigeninc.com.

Forward-Looking Statements

This news release contains forward-looking statements by Qualigen that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to the Company's prospects and strategy for the development of therapeutic drug candidates. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that the Company will successfully develop any drugs (including QN-302, QN-247 and RAS-F); that preclinical development of the Company's drugs (including QN-302, QN-247 and RAS-F, and the deprioritized infectious-disease drug candidate QN-165) will be completed on any projected timeline or will be successful; that any clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline, or at all; that any future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs will receive required regulatory approvals (or Fast Track designation or Orphan Drug status) or that they will be commercially successful; that patents will issue on the Company's owned and in-licensed patent applications; that such patents, if any, and the Company's currently owned and in-licensed patents would prevent competition; that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company's prospective therapeutic products (including QN-302, QN-247 and RAS-F, and QN-165); or that the Company will be able to maintain or expand market demand and/or market share for the Company's diagnostic products. The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business can be found in the Company's prior filings with the Securities and Exchange Commission, including its most recent Form 10-K, all of which are available at http://www.sec.gov.

The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:

Jules AbrahamJQA Partners, Inc.917-885-7378jabraham@jqapartners.com

Source: Qualigen Therapeutics, Inc.

AACR POSTER

Structural and Chemical Biology

AACR POSTER - CHART 1

New Chemotherapy Agents

AACR POSTER - CHART 2

Tumor Volumes for CTG-1128

AACR POSTER - CHART 3

Tumor Volumes for CTG-0952

AACR POSTER - CHART 4

Tumor Volumes for CTG-2184

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Qualigen Therapeutics Presents Three Posters of QN-302 at American Association of Cancer Research Conference - StreetInsider.com

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