CARLSBAD, Calif., Aug. 17, 2023 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, announced today it is partnering with Translational Drug Development (TD2) as the contract research organization (CRO) to conduct the Phase 1 clinical development of lead drug candidate QN-302. Qualigen received US FDA IND clearance earlier this month to initiate a Phase 1 clinical trial of QN-302, a small molecule G-Quadruplex (G4)-selective transcription inhibitor, for the treatment of advanced or metastatic solid tumors.

Tariq Arshad, M.D., M.B.A., Chief Medical Officer, stated: “I am delighted that the FDA has cleared QN-302 to enter the clinic for the proposed Phase 1 clinical trial in patients with advanced or metastatic patients with solid tumors. This furthers our ongoing investigation of a potentially exciting new therapeutic approach for this group of cancer patients with high unmet medical need along with our assessment of corresponding biomarkers relevant to G4 expression. TD2, our CRO partner, has been instrumental in bringing us to this point. Their demonstrated ability to meet critical timelines within budget reinforces its status as an industry leader in preclinical and clinical oncology drug development, maximizing the opportunity for QN-302 to reach the patients who need it the most.”

TD2 is a precision oncology drug development organization integrating preclinical, clinical, and regulatory expertise and providing expert drug development services, including the design and execution of oncology clinical trials. TD2 has a proven track record of obtaining IND clearances and managing complex trial designs, including recruitment for Orphan diseases, to accomplish first patient dosing as quickly as possible.

“The successful IND filing of QN-302 is the result of a strong partnership and shared dedication between Qualigen and TD2 to advance cancer therapeutics into patients who may have run out of options," said Stephen Gately, Ph.D., President and CEO of TD2. "We appreciate the chance to work with Qualigen on this exciting development program and look forward to the upcoming clinical data.”

Qualigen Therapeutics secured exclusive worldwide rights to QN-302 in January 2022 from University College London (UCL). QN-302 was invented and developed by Professor Stephen Neidle and his team from the UCL School of Pharmacy, one of the top ten pharmacy and pharmacology research institutions in the world. Professor Neidle has a distinguished 30+ year history in nucleic acid research and drug design with over 500 published papers and 14 patents and has been a member of Qualigen’s QN-302 Scientific Advisory Board since February 2022.

Professor Neidle stated, “I’m delighted that our novel experimental drug QN-302 is at this very exciting stage of now having FDA clearance for clinical evaluation. We are so pleased that Qualigen has not only shared our vision but has taken QN-302 with remarkable skill and speed to this important milestone. I am proud that we have long been a pioneer of the quadruplex targeting concept and now look forward to the clinical development of QN-302.”

Qualigen plans to initiate activation of the first Phase 1 clinical trial site and enroll the first patient in the Phase 1 dose escalation clinical study later this year. Qualigen will enroll patients with advanced or metastatic solid tumors who have failed prior therapy.

About QN-302

QN-302 is a small molecule G-Quadruplex (G4)-selective transcription inhibitor in Phase 1 clinical development for the treatment of G4-expressing solid tumors, such as pancreatic cancer (PDAC), prostate cancer, sarcomas, and others. QN-302 stabilizes G4 complexes prevalent in the promoter region of oncogenes in many tumor types, impeding transcription of G4-containing cancer genes and may potentially offer a tumor-agnostic clinical approach to treatment. Orphan Drug Designation (ODD) was granted by the FDA in January of this year for QN-302 for the intended indication of pancreatic cancer.

About Qualigen Therapeutics, Inc.

Qualigen Therapeutics, Inc. is a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer. 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 Pan-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.

About Translational Drug Development (TD2)

TD2 is a leader in precision oncology, providing innovative services for improved drug development. Using a dedicated, expert team with broad experience and understanding in cancer medicine, TD2 is uniquely positioned to support accelerated development of novel therapeutics. Rigorous and high-throughput translational preclinical development services, combined with regulatory affairs expertise, enables customized clinical trial design and execution. Our broad suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process with the ultimate goal of accelerating patient access to promising treatments. For more information, visit www.TD2inc.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 development of its therapeutic drug candidates, including the anticipated timeline for initiating the Company’s Phase 1 clinical trial and enrolling and dosing of patients and the identification of a late in vivo candidate. Actual events or results may differ from the Company's expectations. There can be no assurance that the Company will be able to successfully develop any drugs (including QN-302, Pan-RAS and QN-247); that preclinical development of the Company's drugs (including Pan-RAS and QN-247) 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, Pan-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 fail 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 annual report on 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.

For more information about Qualigen Therapeutics, Inc., please visit www.qlgntx.com.

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