Pharma Focus America

Qualigen Therapeutics Granted US FDA IND Approval to Initiate Phase 1 Clinical Trial of QN-302 for Advanced or Metastatic Solid Tumors Treatment

Wednesday, August 02, 2023

Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a clinical-stage biotech company specializing in cancer treatments for both adult and pediatric patients, has announced that the U.S. Food and Drug Administration (FDA) has approved its IND application for QN-302. This drug is a potential leading-edge small molecule G-Quadruplex (G4)-selective transcription inhibitor.

With this clearance, Qualigen is now preparing to commence a Phase 1 clinical trial in the latter half of 2023, enrolling individuals who suffer from advanced or metastatic solid tumors.

Michael Poirier, Chairman and CEO of Qualigen, expressed his enthusiasm, stating that the IND clearance marks a pivotal milestone for their therapeutics pipeline, as they transition into the clinical-stage phase. He further added that the approval for QN-302 brings them closer to their goal of developing top-tier treatments that may offer new therapeutic options for patients with advanced or metastatic solid tumors. The company's clinical team has diligently prepared for this milestone and is focused on initiating patient enrollment, anticipated to take place in the second half of 2023.

The proposed Phase 1 clinical trial will be a multicenter, open-label study that includes dose escalation, safety, pharmacokinetic, and pharmacodynamic assessments. The trial will also have dose expansion to evaluate the safety, tolerability, and antitumor activity of QN-302 in patients with advanced solid tumors that have not responded to or have relapsed after receiving available therapies. Qualigen expects to dose at least 24 patients during the Phase 1 trial, which is projected to be completed in 2024. Funding for the trial will, in part, come from proceeds received by divesting the company's diagnostics business in July 2023.

QN-302 is a small molecule G-Quadruplex (G4)-selective transcription inhibitor that is currently in Phase 1 clinical development. It aims to treat G4-expressing solid tumors, such as pancreatic cancer (PDAC), prostate cancer, sarcomas, and other tumor types. The drug functions by stabilizing G4 complexes, which are prevalent in the promoter region of oncogenes in various cancer types, thereby inhibiting the transcription of G4-containing cancer genes. This mechanism of action holds promise for providing a tumor-agnostic clinical approach to treatment. In January of the same year, the FDA granted Orphan Drug Designation (ODD) to QN-302 for the intended indication of pancreatic cancer.

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