The trial is scheduled to begin in the first quarter of 2024 with sites including Belfast, Glasgow, Newcastle, and the Royal Marsden in London.

CV6-168 will be one of the first novel cancer drugs to be developed and trialed in Northern Ireland. This announcement will significantly boost the region’s credibility and visibility in cancer drug development, and further strengthen it as a global leader in the health and life sciences sector.

Pre-clinical studies have already shown that CV6-168 works alongside standard cancer therapies to activate a unique action that induces cancer cell DNA damage and cell death while at the same time activating the patient’s own immune system to further enhance its anti-cancer effect.

This UK multi-centre clinical trial will further test the drug and will combine CV6-168 with a chemotherapy drug, infusional 5-FU, to treat gastrointestinal cancer patients, such as colon, gastric, and pancreatic cancers, as well as other tumor types such as melanoma, lung, and ovarian cancers.

Commenting on the announcement, Dr Robert Ladner, Founder and CEO of CV6 Therapeutics said: “This regulatory approval is a key milestone as we progress CV6-168 into a first-in-human Phase 1 clinical trial. This trial will focus on safety, measuring how the drug is absorbed by the body, identifying optimal dosing levels and gathering initial indications of anti-cancer effectiveness.

“Our innovative oncology drug is a promising new therapeutic approach to cancer treatment, with the opportunity to potentially treat many millions of patients annually across multiple high-incidence cancer types.”

CV6 Therapeutics, originally founded by CEO Dr Robert Ladner in Los Angeles, relocated to Northern Ireland from the USA in 2015, attracted by the research capabilities here and the opportunity to collaborate with Queen’s University. It is now headquartered in the Patrick G. Johnston Centre for Cancer Research at the University and employs a team of researchers who specialise in leading edge cancer research.

Queen’s University Belfast Vice-Chancellor, Professor Sir Ian Greer said: "Thanks to collaboration with key players in health and business across Queen’s, we are delighted that this drug developed by CV6 at Queen’s has been approved to enter the clinical trial stage. Tackling cancer is an integral part of the University’s ‘One Health Strategy’ and this success highlights our ability to lead and deliver high quality research with real patient impact."

Professor Dan Longley, Director of the Patrick G. Johnston Centre for Cancer Research at Queen’s University Belfast said: “This is a landmark achievement for cancer research at the Patrick G. Johnston Centre for Cancer Research at Queen’s: a cancer drug developed in Belfast that will be used to treat patients in Belfast.

“This is a day that Paddy Johnston, after whom our cancer research centre is named, would be very proud. Paddy was a leader in the field of research that has led to this breakthrough and was instrumental in recruiting the CV6 team to Belfast, where they have developed this highly promising new anti-cancer drug CV6-168. Today’s announcement puts Queen’s at the forefront of world-class cancer research.”

Media

Media inquiries to Sian Devlin at s.devlin@qub.ac.uk