14 Dec CV6 Receive MHRA Approval for UK-Wide Trials
Congratulations to portfolio company, CV6 Therapeutics, (NI) Ltd. and, in particular, Robert D. Ladner, Ph.D. on this significant commercial milestone.
We look forward to following developments with interest as the company commences its first-in-human clinical trial.
Article taken from:
CV6 Therapeutics Receives MHRA Approval for Novel Cancer Therapy Phase 1a Clinical Trial (yahoo.com)
CV6 Therapeutics Thu, December 14, 2023 at 8:00 AM GMT
BELFAST, United Kingdom, Dec. 14, 2023 (GLOBE NEWSWIRE) — CV6 Therapeutics (‘CV6’), a drug development biotechnology company that specializes in innovative small molecule therapeutics for cancer and inflammatory diseases, announces it has received approval from the UK’s medicines regulator, the MHRA, for the company’s first-in-human Phase 1a clinical trial of its lead oncology therapeutic, CV6-168, in patients with colorectal and other cancers.
CV6-168 is a first-in-class DNA uracilation agent that selectively targets the enzyme dUTPase. Cancer cell DNA uracilation by CV6-168 is aided by combination with standard cancer therapies including thymidylate synthase (TS) inhibitors such as 5-fluorouracil (5-FU). These CV6-168 drug combinations result in targeted uracil-based DNA damage and cancer cell death while simultaneously stimulating the immune system to further enhance the anticancer effect. DNA uracilation is a novel therapeutic strategy that has demonstrated effectiveness and safety in pre-clinical models with no added toxicity when combined with standard-of-care anti-cancer drugs.
The UK multi-centre Phase 1a clinical trial will combine CV6-168 with 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. It will focus on safety, measuring how CV6-168 is absorbed by the body, identifying optimal dosing levels, and gathering initial indications of anti-cancer activity. The initial trial is for up to 50 patients, taking part at leading cancer hospitals in Belfast, Glasgow, Newcastle, and the Royal Marsden in London that are within the UK Experimental Cancer Medicine Centre (ECMC) network. The trial is expected to have dosed its first patient in Q1 2024, with trial read-outs expected in H1 2025.
CV6 CEO and Founder Dr Robert Ladner said, “This regulatory approval is a key milestone as we progress CV6-168 into a first-in-human Phase 1a clinical trial. Our innovative oncology therapeutic unlocks the potential of DNA uracilation as a promising new therapeutic approach to cancer treatment, with the opportunity to significantly improve outcomes for patients across multiple cancer types. CV6-168 is a specific, first-in-class dUTPase inhibitor that has a value-driven therapeutic approach, is globally scalable, and can potentially treat many millions of patients annually across multiple high-incidence cancer types.”
The Chief Investigator for this trial is Richard Wilson, who is Professor of Gastrointestinal Oncology in the University of Glasgow and specialises in early and late phase cancer clinical trials. He said, “Despite recent advances, there is still huge unmet need for new treatments for colorectal and many other cancers. CV6-168 in combination with 5-FU has the potential to improve on existing treatments, where 5-FU and similar drugs are currently used, in over 8 million people with cancer annually across the world. What sets CV6-168 apart is that the DNA uracilation mechanism selectively damages cancer cell DNA but also triggers signals to the immune system opening up the potential to unleash our natural immunity against the cancer cells. CV6-168 is given by mouth which makes it very easy to combine with other drugs and lessens the burden on patients receiving it. If CV6-168 fulfils its’ promise, then this will give us a new therapeutic option that is easy to take alongside existing standard anti-cancer drugs, and with minimal additional side-effects.”
CV6 Therapeutics, originally founded in Los Angeles, is now headquartered in the Patrick G. Johnston Centre for Cancer Research at Queen’s University Belfast.
About CV6 Therapeutics
CV6 Therapeutics, (NI) Ltd., is a drug development biotechnology company that specializes in value-based, first-in-class, small molecule therapeutics that are scalable to address global unmet medical needs for cancer and inflammatory diseases.
Its lead oncology drug candidate CV6-168 has successfully completed all pre-clinical development milestones. The company has UK regulatory approval to start a first-in-human phase 1a clinical trial of CV6-168 in advanced cancers in 2024. The company’s inflammatory disease asset CV6-1271 is in preclinical-development.
CV6 has a Grant for R&D from Invest Northern Ireland to support the Phase 1a trial. (1).
Investors include QUBIS, the commercialization arm of Queen’s University in Belfast, Invest Northern Ireland, CoFund NI, managed by Clarendon Fund Managers, Techstart Ventures as well as US and UK-based private investors.
CV6 Therapeutics, originally founded in Los Angeles, is now headquartered in the Patrick G. Johnston Centre for Cancer Research at Queen’s University Belfast.
For more information see our website here and LinkedIn here.
References
(1) Invest Northern Ireland’s R&D support is part financed by the European Regional Development Fund under the EU Investment for Growth and Jobs Programme 2014–2020.
Media Contacts
CV6 Therapeutics
Dr Robert Ladner, CEO
+44 (0) 7500 444287
rladner@cv6t.com