Investigational New Drug (IND) clearance transitions Qualigen Therapeutics from preclinical to clinical-stage company and demonstrates leadership in G4-targeting therapies for areas of high unmet need in oncology

CARLSBAD, Calif., Aug.  01, 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, announces today that the U.S. Food and Drug Administration (FDA) has cleared the Company's IND application for QN-302, a potential best-in-class small molecule G-Quadruplex (G4)-selective transcription inhibitor. Based on this clearance, the Company plans to initiate the Phase 1 clinical trial in the second half of 2023 and will enroll patients with advanced or metastatic solid tumors.

Michael Poirier, Qualigen's Chairman and CEO, commented, "This is a pivotal milestone for our therapeutics pipeline as it transitions us into a clinical-stage company. The IND clearance for QN-302 brings us closer to our objective of developing best in class treatments that can potentially provide new therapeutic options for patients with advanced or metastatic solid tumors. Our clinical team has worked diligently to prepare for this milestone and is now dedicated to start enrolling patients, anticipated to take place in the second half of 2023."

The proposed Phase 1 trial is a multicenter, open-label, dose escalation, safety, pharmacokinetic, and pharmacodynamic study with dose expansion to evaluate safety, tolerability, and antitumor activity of QN-302 in patients with advanced solid tumors that have not responded to or have recurred following treatment with available therapies. The Company anticipates the dosing of at least 24 patients in the Phase 1 trial can be completed in 2024, funded in part by proceeds received by the divestiture of the Company's diagnostics business in July 2023.

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 potentially offering 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.