Epitopea wins UK approval for therapeutic vaccine trial

Epitopea has received approval from the UK medicines regulator and the Regional Ethics Committee for OVACT, its first-in-human trial of lead candidate CryptiVax-1001 in advanced high-grade serous ovarian cancer. The biotech with offices in the UK and Canada is developing off-the-shelf RNA-based cancer immunotherapies and is now moving its lead programme into the clinic.

OVACT is a Phase I/Ib dose-escalation and expansion study designed to evaluate the safety, tolerability, immunogenicity and early clinical activity of CryptiVax-1001 in HRP+/BRCA-wildtype high-grade serous ovarian cancer. That is a particularly relevant patient group because many women with advanced disease relapse after first-line chemotherapy and still have limited maintenance options.

Epitopea’s approach is built on its CryptoMap discovery engine, which identifies tumour-presented antigens arising from the dark genome and feeds them into its Cryptigen antigen platform. The company says these tumour-specific targets could support true off-the-shelf mRNA immunotherapies with broad patient coverage rather than highly bespoke treatment design.

High-grade serous ovarian cancer remains one of the hardest solid tumours to treat, with most patients diagnosed at an advanced stage and nearly all eventually developing resistance or relapse. In that context, even an early clinical entry is a meaningful step, although the real test will be whether the vaccine can generate a durable immune response and translate that into clinical benefit.

“There is a substantial unmet need in homologous recombination proficient (HRP) ovarian cancer, where available maintenance therapies deliver limited durable benefit,” explained Susana Banerjee a Consultant Medical Oncologist and Research Lead for the Gynaecology Unit at The Royal Marsden NHS Foundation Trust and Professor in Women’s Cancers at the Institute of Cancer Research, who was appointed Chief Investigator of the trial. “Epitopea’s CryptiVax-1001 vaccine, which targets a novel repertoire of tumor-specific antigens, has the potential to meaningfully extend remission for patients with few effective treatment options.”