Qualigen Therapeutics Initiates Good Laboratory Practice (GLP) Toxicology Studies on QN-302

CARLSBAD, Calif., Jan. 24, 2023 (GLOBE NEWSWIRE) — Qualigen Therapeutics, Inc. (“Qualigen” or “the Company,” 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 initiation of Good Laboratory Practice (GLP) toxicology studies of its lead oncology program, QN-302, a G4-selective transcription inhibitor currently in development for the treatment of G4 (G-Quadruplex) expressing solid tumors, including pancreatic cancer.

The study will be conducted by WuXi AppTec, a leading provider of R&D and manufacturing services that enable the pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients.

GLP toxicology studies are a core component of QN-302’s Investigational New Drug (IND) submission package, which is expected to occur in the first half of 2023, and will be followed by human clinical trials once the IND is cleared by the US FDA.

“Among the key steps in establishing safety of QN-302 as a targeted anti-cancer therapy is to determine its preclinical toxicity profile to ensure that patients who receive the drug can safely do so. These GLP toxicity studies will generate important data as we develop our submission to the U.S. Food and Drug Administration to initiate Phase 1 clinical trials for QN-302,” commented Tariq Arshad, M.D., M.B.A., Qualigen’s Chief Medical Officer.

Qualigen President and Chief Strategy Officer, Amy Broidrick added, “Embarking on these studies is a critical milestone and a testament to our team’s focus on execution within our stated timeline. We are pleased with the progress of our lead program, QN-302, and are steadfast in our commitment to develop much-needed treatments for cancer patients with unmet medical needs.”

Pancreatic cancer is a highly lethal disease and the third most common cause of cancer death in the United States. In-vitro and in-vivo pre-clinical studies of QN-302 have shown that G4 stabilization may result in inhibition of target gene expression and cessation of cell growth in a variety of cancers, including pancreatic ductal adenocarcinoma (“PDAC”), which represents 98% of pancreatic cancers.

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. The investigational compounds within Qualigen’s 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. 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). 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, including statements related to the development of QN-302, including the anticipated timing for our IND application submission, and the Company’s other 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 be able to successfully develop any drugs (including QN-302, RAS, and QN-247); that preclinical development of the Company’s drugs (including QN-302, RAS, and QN-247, 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; or 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, RAS, and QN-247). 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.


Jules Abraham
JQA Partners, Inc.

Source: Qualigen Therapeutics, Inc.

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