Epitopea Announces Approval of OVACT Clinical Trial Application for CryptiVax-1001 in Advanced High-Grade Serous Ovarian Cancer

Appoints Leading Oncologist Professor Susana Banerjee of The Royal Marsden as Chief Investigator 

CAMBRIDGE, UK and MONTREAL, CANADA, 23 April 2026 – Epitopea, a transatlantic biotech developing off-the-shelf, durable, RNA-based cancer immunotherapies, today announced that it has received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Regional Ethics Committee (REC) for its clinical trial application (CTA) for its first-in-human clinical trial (OVACT) of its lead program, CryptiVax™-1001, targeting advanced high-grade serous ovarian cancer. 

Epitopea also announces the appointment of Professor Susana Banerjee (MBBS MA PhD FRCP), 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, as Chief Investigator of the OVACT trial. 

Dr. Klaus Edvardsen, MD, Chief Medical Officer of Epitopea, commented, “We are excited by the achievement of this significant regulatory milestone, which is a credit to our dedicated clinical and wider Epitopea team. We also welcome Professor Banerjee to her role as Chief Investigator of our first clinical trial. Her world-class expertise in ovarian cancer and leadership in global clinical development will bring invaluable insights as we transition to a clinical-stage company.”

OVACT is a Phase 1/1b dose escalation and expansion trial designed to evaluate the safety, tolerability, immunogenicity, and early clinical activity of CryptiVax™-1001 in HRP+/BRCA-wildtype high-grade serous ovarian cancer patients. 

High-Grade Serous Ovarian Cancer (HGSOC) remains one of the most difficult-to-treat solid tumors, with most patients (~80%) presenting with advanced or metastatic disease. While most women respond to first-line platinum chemotherapy, nearly all ultimately relapse and progress to platinum-resistant disease. Existing maintenance options leave a major therapeutic gap among HRP+/BRCA-wildtype patients, who represent roughly half of the ovarian cancer population. 

Professor Banerjee added: “There is a substantial unmet need in homologous recombination proficient (HRP) ovarian cancer, where available maintenance therapies deliver limited durable benefit. 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.” 

Epitopea’s pipeline is enabled by CryptoMap^TM, a proprietary discovery engine that identifies tumor-presented antigens arising from the dark genome, a previously inaccessible source of novel, tumor-specific targets. These antigens, known as Cryptigens^TM, demonstrate high inter-patient sharing, enabling development of true off-the-shelf mRNA immunotherapies. 

Caption: Professor Susana Banerjee, Chief Investigator, Epitopea