UCL School of Pharmacy


Novel approach to cancer therapy pioneered by UCL scientists given US FDA IND clearance

9 August 2023

Stephen Neidle has long been a pioneer of a novel approach to cancer therapy. Using specially designed compounds, this approach targets the unusual signal sequences present in elevated levels in many cancer-associated genes, including those involved in pancreatic cancer.

Two researchers working in a lab using pipettes

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.”

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Researchers at UCL School of Pharmacy working in a laboratory. Image by David Bishop.