A tumour-busting drug developed at UCL in London, which scientists say could improve the current “dismal outlook” for people with pancreatic cancer, is set to be trialled in patients following U.S regulatory approval.
Pancreatic cancer is one of the most lethal forms of cancer, with a five-year survival rate of less than 8%, according to data from Public Health England. In the UK alone, approximately 11,000 new cases are diagnosed annually.
Professor Neidle (Emeritus Professor, UCL School of Pharmacy) and his group, with support from the UCL Technology Fund and the UCL Drug Discovery Group, have used his approach to invent and then develop a novel experimental drug “QN-302” for the treatment of pancreatic and other cancers.
QN-302 was licensed by UCL Business at the beginning of 2022 to Qualigen Therapeutics, Inc., a clinical-stage company specialising in developing treatments for adult and paediatric cancers, including those with potential for Orphan Drug Designation. Qualigen has now announced that a significant milestone has been reached in the development of QN-302.
The U.S. Food and Drug Administration (FDA) has granted clearance for the company’s Investigational New Drug (IND) application for QN-302, which the company believes could be a potential best-in-class drug. With this regulatory clearance in hand, Qualigen plans to initiate Phase 1 clinical trials in the second half of 2023 and will enrol patients with advanced or metastatic solid tumours.
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 tumours. 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.”
Professor Stephen Neidle, the leader of the UCL team, commented: “I’m extremely delighted that our novel experimental drug QN-302 is at this very exciting stage of now having FDA approval for clinical evaluation. We are so pleased that Qualigen Therapeutics has not only shared our vision but has taken QN-302 with remarkable skill and speed to this important milestone. I am proud that my team has long been a pioneer of the quadruplex targeting concept and now look forward to the clinical development of QN-302. I shall continue, with my collaborators, to further our understanding of the basic science involved in its action.”
Dr Sara Garcia Gomez, Senior Business Manager, UCL Business, said: “This is great news from Qualigen, our licensee, taking this UCL technology to the next level on the translation pathway. We‘re looking forward to seeing the potential of this new therapy in the clinic very soon.”