CV6 Announces Initiation of Patient Dosing in Phase 1a Clinical Trial Evaluating the Investigational First-In-Class, Specific dUTPase Inhibitor CV6-168

Belfast, UK, 15 August 2024 –

CV6 Therapeutics (NI) Ltd. (“CV6”), a clinical-stage pharmaceutical company dedicated to improving the lives of patients with cancer and inflammatory diseases by developing novel, first-in-class, small molecules targeting Uracil-DNA metabolism, today announced the successful dosing of the second patient in its Phase 1a study evaluating CV6-168 + infusional 5-fluorouracil (5-FU) in cancer patients.

This Phase 1 part of this modular, first-in-human Phase 1a clinical trial (ISRCTN12434145) is a multicenter, open-label, dose-escalation study of CV6-168 in patients with advanced metastatic solid tumors refractory to standard treatment. The primary objectives of the study are to determine the following parameters for CV6-168: safety profile, potential optimal biologically relevant doses, maximum tolerated dose, and anti-tumor activity.

“CV6-168 induces DNA Uracilation, a novel mechanism of action, and is our first drug candidate to enter the clinic. CV6-168 has the potential to treat a variety of commonly occurring cancers in combination with cornerstone therapies that are used to treat millions of patients per year globally,” said Dr Robert D. Ladner, founder, and chief executive officer at CV6. “CV6-168 accelerates the translation of Uracil-DNA biology by inducing the misincorporation of uracil into cancer cell DNA resulting in repair-mediated DNA damage, immune modulation and cell death into clinical applications. The dosing of the second patient in our first clinical trial marks an important milestone as CV6 works to deliver new and effective first-in-class small molecules with a novel mechanism of action to patients facing common, difficult-to-treat cancers.”

CV6-168 is a novel, targeted, small molecule, dUTPase-specific inhibitor in development for the treatment of multiple, high-incidence cancers. In preclinical studies, it has demonstrated robust anti-tumor activity in cell line and animal models with no added toxicity. CV6-168 targets the nucleotide metabolism enzyme dUTPase, with high specificity, avoiding drug-drug interactions with its drug combination partners that include thymidylate synthase (TS) inhibitors like 5-fluorouracil (5-FU).

About CV6 Therapeutics

CV6 is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutic agents for patients with cancer and inflammatory diseases. CV6 develops innovative, first-in-class therapies with a novel mechanism of action by targeting dUTPase and Uracil-DNA Metabolism – an area of research that its founder helped pioneer. Its lead oncology drug candidate CV6-168 is in a Phase 1a clinical trial in advanced cancers.

Investors include QUBIS, the commercialization arm of Queen’s University in Belfast, Invest Northern Ireland, CoFund NI, managed by Clarendon Fund Managers, and Techstart Ventures, as well as US, UK, European, and Australian-based private investors.

CV6 is headquartered in Belfast, Northern Ireland, UK, with research facilities at Queen’s University Belfast in the Patrick G Johnston Centre for Cancer Research.

For additional information, please visit CV6’s website at www.cv6t.com and follow us on Linkedin.

Photo. CEO and Founder of CV6, Dr Robert Ladner (right) with CV6-168 Phase 1a clinical trial lead investigator Prof. Richard Wilson, University of Glasgow (left) and Prof. Udai Banerji, lead investigator at the Institute for Cancer Research (middle) at the Clinical Trials in Progress session at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago in June 2024.

CV6 Therapeutics

Dr Robert Ladner, CEO / rladner@cv6t.com / +447500444287

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