Qualigen Therapeutics, Inc. announced 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. 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. QN-302 is a small molecule G-Quad Truplex (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.