Qualigen Therapeutics partners with TD2 for Phase 1 development of QN-302

Qualigen Therapeutics is partnering with Translational Drug Development as the contract research organization 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-selective transcription inhibitor, for the treatment of advanced or metastatic solid tumors. 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. Qualigen Therapeutics secured exclusive worldwide rights to QN-302 in January 2022 from University College London. 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. 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.