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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.
Posted In: QLGN
