Qualigen Therapeutics Extends Research Agreement with University of Louisville Research Foundation on RAS Program

Rhea-AI Summary

Qualigen Therapeutics, Inc. (Nasdaq: QLGN) announced the extension of its research agreement with the University of Louisville Research Foundation. This collaboration aims to further develop the RAS-F platform, targeting solid tumors. The partnership enhances efforts to identify candidates for IND-enabling studies by late 2022. The RAS-F program involves small molecules designed to inhibit mutated RAS proteins, which are prevalent in various cancers. Mutant RAS is implicated in 25% of cancers, and targeting its pathways may provide new therapeutic avenues.

Positive

• Extension of research agreement with University of Louisville enhances RAS-F platform development.
• Potential identification of lead candidates for IND-enabling studies by late 2022.
• Unique RAS-F program targets broad range of RAS mutations, applicable to multiple cancer types.

Negative

• No guarantee of successful drug development or favorable clinical trial results.
• Uncertainty regarding future regulatory approvals and market demand.
• Forward-looking statements indicate potential risks that may impact stock performance.

CARLSBAD, Calif., March 15, 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 announces the mutual extension of a research agreement with University of Louisville Research Foundation (ULRF). The revised agreement expands the Company’s collaboration with the research institution to develop its ongoing RAS-F platform currently in the discovery stage for solid tumors through Q1 of 2023.

“This extension of our agreement with ULRF represents our continued commitment to develop our exciting RAS-F platform by leveraging the ongoing relationship with this prestigious research institution,” commented Michael Poirier, Qualigen’s CEO. “We are both proud to be associated with ULRF and confident that our further collaboration may serve to identify the lead candidate for IND-enabling studies by late 2022.”

Geoffrey Clark, Ph.D., Professor of Pharmacology and Toxicology at University of Louisville (UofL), stated, “The partnership with Qualigen Therapeutics has been very important to us. The expanded agreement gives our team the opportunity to generate and select additional compounds, fully explore mechanisms within the RAS pathway, and drive the program towards a lead clinical candidate.”

Mutant RAS is the most common cancer oncogene, present in one quarter of all cancers. It acts as a “hub” that activates multiple effector pathways to promote cancer growth. Targeting the downstream PI3K-AKT and RAF-MEK-ERK signaling pathways has been a promising therapeutic approach to date. However, approved therapeutic options are limited to cancers exhibiting specific RAS mutations, such as KRAS G12C. Exploring additional downstream effectors of the RAS pathway such as the RAL GTPase family are areas of active research as there are no FDA-approved pan-mutational RAS protein inhibitors.

Qualigen’s RAS-F program is a family of small molecules designed to prevent mutated RAS gene proteins from binding to their effector proteins. Exclusively in-licensed from UofL, compounds from this discovery engine have been shown to inhibit a broad range of RAS mutations and are active against the growth of multiple in vivo tumor models. Qualigen is evaluating promising compounds generated from this partnership in various RAS-driven advanced solid tumors such as pancreatic, colorectal and lung cancers.

About Qualigen Therapeutics, Inc.

Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for 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 Qualigen’s 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 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 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.

Investor Relations:
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com

Source: Qualigen Therapeutics, Inc.

FAQ

What is the recent announcement from Qualigen Therapeutics regarding QLGN?

Qualigen announced an extension of its research agreement with the University of Louisville Research Foundation to develop its RAS-F platform.

How does the RAS-F platform benefit cancer treatment?

The RAS-F platform aims to inhibit mutated RAS proteins, which are present in about 25% of cancers, potentially offering new treatment options.

When is Qualigen Therapeutics planning to identify lead candidates for their RAS-F platform?

Qualigen aims to identify lead candidates for IND-enabling studies by late 2022.

What risks are associated with Qualigen's drug development initiatives?

Risks include uncertainties in successful drug development, clinical trial outcomes, and regulatory approvals.