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, CA, USA I July 22, 2020 I 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/.  

SOURCE: Qualigen Therapeutics

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