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CARLSBAD, Calif., Nov. 14, 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,today provides a corporate update for the third quarter ending September 30, 2023 and to date:
Highlights:
QN-302
Pan-RAS
Dear Shareholders:
In the third quarter to date this year, we completed our transition from a diversified life science company to a streamlined clinical stage therapeutics company focused on execution and judicious capital deployment toward our differentiated oncology pipeline for the benefit of patients worldwide. In July we announced the divestiture of our FastPack® diagnostics business for approximately $5 million in an all-cash transaction to support advancement of our therapeutics pipeline.
Our team and collaborators have worked diligently to advance our QN-302 program on time and within budget. We are excited to announce the initiation of dosing of not only our first patient, but of our first cohort of three patients in the Phase 1a dose escalation portion of our clinical trial of QN-302, an investigational G4-selective transcription inhibitor. This follows the announcement of QN-302 receiving US FDA Investigational New Drug (IND) clearance to initiate the clinical trial in July and the announcement of first patient dosed last week. Our Pan-RAS inhibitor platform continues to present compelling in vivo data in multiple cancer models as we make progress toward identifying a lead candidate for IND-enabling studies under our sponsored research collaboration with the University of Louisville, Kentucky.
About Our Phase 1 Clinical Trial for QN-302
As stated above, our focus in 2023 has been the swift execution of business priorities. We initiated IND-enabling studies for QN-302 in January 2022, when the technology package was exclusively in-licensed from the University College London, having been discovered and developed by Dr. Stephen Neidle's group at the School of Pharmacy. We enlisted our CRO, TD2, and within 18 months of initiating IND-enabling studies we received IND clearance to initiate Phase 1 clinical trials by the US FDA. In January 2023 we obtained Orphan Drug Designation for the potential treatment of pancreatic cancer.
Details of our Phase 1 study are as follows:
Title: A Phase I, Multicenter, Open-label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacodynamics, and Pharmacokinetics of Intravenous QN-302 in Patients With Advanced or Metastatic Solid Tumors
Pending the Company's ability to secure additional capital, up to 36 patients will be enrolled in the dose escalation (Phase 1a) portion of the study. The exact number of patients to be enrolled will depend on the observed safety profile. The dose expansion (Phase 1b) cohort may enroll up to an additional 20 patients with advanced, metastatic solid tumors. The expansion cohort will further evaluate safety and assess for antitumor effect of QN-302.
The primary objectives of this Phase 1a study are:
The secondary objectives of the Phase 1a study are:
About Our Pan-RAS Inhibitor Platform
We continue to build our data package for our lead optimization stage Pan-RAS inhibitor platform. Along with our team at the University of Louisville, we presented a poster in June at the American Society of Clinical Oncology's (ASCO) 2023 Annual Meeting highlighting the ability of our pre-lead compounds to potentially overcome emerging resistance and limited clinical durability of commercially approved KRAS G12C inhibitors. This is an exciting development that we are actively exploring under our sponsored research agreement. More recently, in September our collaborator Dr. Geoff Clark presented at the American Association of Cancer Research: Advances in Breast Cancer Special Meeting describing data supporting how new pre-lead Pan-RAS candidates suppressed RAS signaling pathways (MAPK and RAL pathways) via anti-tumor activity in a breast cancer vivo model.
We believe RAS continues to be a promising target. RAS is the most common cancer oncogene and activating mutations occur in one of the three human RAS gene isoforms (KRAS, HRAS, or NRAS) are present in about one-fourth of all cancers. In fact, mutant KRAS is found in 98% of pancreatic ductal adenocarcinomas, 52% of colon cancers, and 32% of lung adenocarcinomas. We believe a Pan-RAS inhibitor can complement other therapeutic approaches in development and are looking to advance potential partnerships for this compelling platform. Our goal is to select a lead compound for IND-enabling studies in the first quarter of 2024 and to present new data at major conferences throughout the year.
We are proud of what our team and collaborators have accomplished in the third quarter this year and beyond. For the remainder of the fourth quarter and into 2024 our plan is to continue to execute and deploy capital judiciously on what we believe will be the highest return on investment activities without sacrificing quality, and most importantly, activities for patients who are relying on new therapeutic treatment options. We are encouraged by the feedback we have received at our two active clinical trial sites and welcome potentially adding additional sites next year. We plan to share updates with our QN-302 program and Pan-RAS inhibitor platform in Q1 next year, as well as provide an update on safety and preliminary efficacy for our Phase 1a study for QN-302 in the first half of 2024.
Thank you again for your support.
Sincerely,
Michael S. Poirier, CEO, Chairman of the Board, and Founder
Posted In: QLGN