CV6 Therapeutics Begins Patient Dosing in Phase 1a Trial for dUTPase Inhibitor CV6-168

CV6 Therapeutics (NI) Ltd., a pharmaceutical company focused on cancer and inflammatory diseases, has recently dosed its second patient in a Phase 1a clinical trial for its drug candidate CV6-168. This trial aims to evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of CV6-168 when combined with 5-fluorouracil (5-FU) in patients with various advanced solid tumors, including colon, gastric, breast, ovarian, and lung cancers.

The Phase 1a trial is a multicenter, open-label, dose-escalation study involving patients with advanced metastatic solid tumors that are resistant to standard treatments. Key objectives of this study are to assess the safety profile, determine the potentially optimal biologically relevant doses, establish the maximum tolerated dose, and measure the anti-tumor activity of CV6-168.

CV6-168 operates through a novel mechanism known as DNA Uracilation. This process induces the misincorporation of uracil into cancer cell DNA, leading to DNA damage, immune response modulation, and eventually cell death. According to Dr. Robert D. Ladner, the founder and CEO of CV6, CV6-168 has the potential to treat a wide range of common cancers in combination with existing therapies that currently treat millions of patients worldwide. The successful dosing of the second patient in this initial clinical trial represents a significant milestone for the company.

Preclinical studies of CV6-168 have shown promising results, demonstrating robust anti-tumor activity in both cell lines and animal models without added toxicity. The drug is a dUTPase-specific inhibitor that targets the nucleotide metabolism enzyme dUTPase with high specificity. This specificity helps avoid drug-drug interactions with other treatment partners, such as thymidylate synthase (TS) inhibitors like 5-FU.

CV6 Therapeutics is deeply invested in the development of its lead oncology drug candidate, CV6-168, which is currently in its Phase 1a clinical trial. The company's primary focus is on developing and commercializing innovative therapeutic agents to improve the lives of patients battling cancer and inflammatory diseases. Their research is rooted in targeting dUTPase and Uracil-DNA metabolism, a pioneering area of study led by the company’s founder.

The company’s 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. Private investors from the US, UK, Europe, and Australia have also contributed to the company's funding.

CV6 Therapeutics is headquartered in Belfast, Northern Ireland, with research facilities located at Queen’s University Belfast in the Patrick G Johnston Centre for Cancer Research. The company remains committed to advancing their first-in-class small molecules to offer new, effective treatments for patients suffering from challenging, treatment-resistant cancers.