Qualigen Therapeutics Receives Positive Pre-IND Response from FDA for the Clinical Development of AS1411 as a Treatment for COVID-19

Plans to File IND Application and Initiate Phase 2a Study in First Half of 2021

CARLSBAD, Calif., Oct. 28, 2020 /PRNewswire/ -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN) today announced receipt of written feedback to its Type B Pre-IND (Pre-Investigational New Drug application) meeting request from the U.S. Food and Drug Administration (FDA) that is in general agreement with the Company's planned clinical development of AS1411, a nucleolin-targeting DNA aptamer drug candidate, for the treatment of COVID-19.

The FDA's response solidifies Qualigen's intention to reprioritize its clinical development program and to first advance AS1411 into clinical trials (for treatment of COVID-19) in the first half of calendar 2021, to be followed next by seeking to advance ALAN into clinical trials against acute myeloid leukemia.  ALAN is AS1411 attached to a gold nanoparticle.

"We are delighted with the FDA's thoughtful and thorough response to our Pre-IND meeting request which provides a pathway for us to move forward with filing the IND application and initiation of a clinical trial in the first half of calendar 2021," stated Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen. "We are in agreement with the FDA's additional recommendations and believe their responses provided the clarity needed to move forward to get AS1411 into clinical trials for the treatment of hospitalized patients with COVID-19. In addition, we look forward to further investigating the potential use of AS1411 as a broader spectrum antiviral therapeutic."

In its Pre-IND meeting request, the Company requested regulatory guidance on its planned randomized, multicenter study to evaluate the safety and efficacy of AS1411 in hospitalized patients with COVID-19.  The FDA's recommendation is to commence with a Phase 2a proof-of-concept study to evaluate safety and initial efficacy in determining the appropriate dose with outcomes assessed at Day 28. The Company and the FDA agree that a Phase 1 clinical trial is not needed here, because in a previous clinical trial against cancer AS1411 has already been shown to meet Phase 1 safety requirements.

"There continues to be a need for novel treatments for COVID-19," stated Paula Bates, PhD, Professor of Medicine at the University of Louisville, who co-invented the technology. "We know that nucleolin plays an important role in the infectivity of viruses and were able to demonstrate in our AS1411 preclinical studies, the aptamer was effective against the SARS-CoV-2 virus at doses indicated to be safe in humans by previous research. As a result, we believe AS1411 has the potential to be a promising therapeutic for COVID-19, as well as for other viral infections."  

Extensive preclinical research conducted at the University of Louisville has demonstrated that AS1411 has potent anti-viral activity against SARS-CoV-2 infection, the novel coronavirus responsible for COVID-19. Qualigen has held an exclusive license to AS1411 since 2018, and in June 2020 Qualigen entered into an exclusive license agreement for the University of Louisville's pending U.S. patent for the use of AS1411 for inhibiting or treating COVID-19. 

About Qualigen Therapeutics, Inc.
Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack® System, which has been used successfully in diagnostics for almost 20 years. The Company's cancer therapeutics pipeline includes ALAN (AS1411-GNP), RAS-F and STARS™. ALAN (AS1411-GNP) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects. The foundational aptamer of ALAN, AS1411, is also being studied for use in treating or even preventing viral-based infectious diseases, including COVID-19.   RAS-F is a family of RAS oncogene protein-protein interaction inhibitor small molecules for preventing mutated RAS genes' proteins from binding to their effector proteins; preventing this binding could stop tumor growth, especially in pancreatic, colorectal and lung cancers. STARS is a DNA/RNA-based treatment device candidate for removal from circulating blood of precisely targeted tumor-produced and viral compounds. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test kits, used in physician offices, clinics and small hospitals around the world. The FastPack System menu includes rapid point-of-care diagnostic tests for cancer, men's health, hormone function, vitamin D status and antibodies against SARS-CoV-2.  Qualigen's facility in Carlsbad, California is FDA and ISO Certified and its FastPack product line is sold worldwide by its commercial partner Sekisui Diagnostics, LLC. For more information on Qualigen Therapeutics, Inc., please visit https://www.qualigeninc.com/.  

Forward-Looking Statements
This news release contains forward-looking statements by the Company 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 timing of the filing and (if any) acceptance of an IND application for AS1411 as a therapy against COVID-19 and the timing of the related clinical trials (if any), and the possible effectiveness of AS1411 against COVID-19 or other viral infections. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline; that the Company will successfully develop any drugs or therapeutic devices; that preclinical or clinical development of the Company's drugs or therapeutic devices will be successful; that 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 or therapeutic devices will receive required regulatory approvals 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 current 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; that the Company will be able to maintain or expand market demand and/or market share for the Company's diagnostic products generally, particularly in view of COVID-19-related  deferral of patients' physician-office visits and FastPack reimbursement pricing challenges; that adoption and placement of FastPack PRO System instruments (which are the only FastPack instruments on which the Company's SARS-CoV-2 IgG test kits can be run) will be widespread; that the Company will be able to manufacture the FastPack PRO System instruments and SARS-CoV-2 IgG test kits successfully; that any commercialization of the FastPack PRO System instruments and SARS-CoV-2 IgG test kits will be profitable; or that the FDA will ultimately approve an Emergency Use Authorization for the Company's SARS-CoV-2 IgG test.  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 (including events beyond the Company's control, such as epidemics and resulting changes) can be found in the Company's prior filings with the Securities and Exchange Commission, available at 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.

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SOURCE Qualigen, Inc.