Qualigen Therapeutics Signs Exclusive License Agreement with the University of Louisville for RAS Interaction Inhibitor Drug Candidates

RAS is the most common oncogene implicated in human cancer

KRAS, HRAS or NRAS mutations are present in approximately one-third of all cancer patients

CARLSBAD, Calif. , July 22, 2020 /PRNewswire/ -- Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (Qualigen or the Company) announced today the signing of an exclusive worldwide license agreement with the University of Louisville (UofL) for the intellectual property covering the "RAS-F" family of RAS oncogene protein-protein interaction inhibitor small molecule drug candidates. Qualigen will evaluate these patent-pending compounds in order to identify a lead drug candidate for further development against one or more cancers.

This license agreement builds upon the Company's April 2019 sponsored research agreement with UofL for the development of RAS protein-protein interaction inhibitor small-molecule drug candidates. Under this new agreement, Qualigen has in-licensed this "RAS-F" compound family of drug candidates and will seek to identify and develop a lead drug candidate from the compound family and, upon commercialization, would pay UofL royalties in the low-to-mid-single-digit percentages on net sales of RAS protein-protein interaction inhibitor licensed products.

"The RAS oncogenes comprise the most frequently mutated class of genes in human cancers, which is why targeting RAS has been fiercely pursued for decades," said Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen.  "New strategies, such as the one we are developing, have recently emerged with the potential for success that may translate into significantly improved therapies and hope for patients with pancreatic, lung, colorectal and other RAS-driven cancers, who currently have limited treatment options. We look forward to working with the University of Louisville, and to advancing this important clinical program with the goal of developing an effective treatment for this unmet need."

Cells can proliferate uncontrollably when hyper-activating mutations occur in one of the three human RAS gene isoforms (KRAS, HRAS or NRAS).  These RAS mutations are present in approximately one-third of all cancers, including a high percentage of pancreatic, colorectal and lung cancers. Although drugs that target downstream signaling of RAS are available, they have shown limited clinical activity (most likely because RAS acts like a hub that activates multiple effectors). As such, blocking any single pathway, or even two, typically provides disappointing clinical effect. By contrast, the RAS-F small molecules' intended mechanism of action is to inhibit or block the binding of mutated RAS to their effector proteins, thereby leaving the proteins from mutated RAS unable to cause further harm. 

"We look forward to working with Qualigen to further develop this dramatic new approach to treating cancer," said Geoffrey Clark, Ph.D., Professor at UofL and co-inventor of the technology, along with UofL's Drs. John Trent and Joe Burlison.

Qualigen has multiple license agreements with UofL for cancer and antiviral drug candidates.  In June 2020, the Company signed an agreement for the exclusive license to AS1411, a DNA aptamer that targets and binds with nucleolin, for the treatment of COVID-19.  Under another technology license agreement with UofL, Qualigen has been developing ALAN (the AS1411 aptamer attached to a gold nanoparticle) as a drug candidate against cancer.

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 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. The FastPack System menu includes 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/.  

Qualigen 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 potential future development, testing and launch of product candidates. Actual events or results may differ from our expectations. For example, there can be no assurance that any of the RAS-F compounds will be safe and effective against cancer in humans; that patents will issue on the Company's in-licensed RAS-F composition-of-matter and use patent applications; that such patents, if any, would prevent competition; ; 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 clinical trials will be approved to begin by or will actually begin by or will proceed as contemplated by any projected timeline; 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 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; that adoption and placement of FastPack PRO System instruments (which are the only FastPack instruments on which the Company's SARS-CoV-2 IgG and cFN test kits can be run) will be widespread; that the Company will be able to manufacture the FastPack PRO System instruments and the SARS-CoV-2 IgG and cFN test kits successfully; or that any commercialization of the FastPack PRO System instruments and SARS-CoV-2 IgG and cFN test kits will be profitable.  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.