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 that it has received feedback from the FDA following a pre-Investigational New Drug (pre-IND) interaction regarding the development pathway to a Phase 1 clinical trial of QN-302 for the treatment of G4-targeted advanced solid tumors. The purpose of the pre-IND interaction was to inform the proposed content of the Company’s IND application and request guidance from the Division on specific questions prior to submission of the IND application. The FDA’s response provides Qualigen with clear guidance for formally submitting an IND application for QN-302 after accounting for the agency’s comments and suggestions.
“We are pleased to have received the feedback from the FDA that informs our plans for the proposed Phase 1 study intended for patients with advanced solid tumors as well as the proposed content of the initial IND application. We remain on track to submit the IND application around the first half of 2023,” said Tariq Arshad, M.D., M.B.A., Qualigen’s Chief Medical Officer.
Qualigen Chairman and CEO, Michael Poirier added, “We value the input we received from the Agency and will ensure that our development team takes into account the FDA’s guidance as we continue our preparations toward IND filing, with input from our Scientific Advisory Board of world class oncology experts from leading cancer research institutions. We look forward to providing updates on our lead therapeutics program, QN-302 as we advance toward the clinic.”
