La MHRA approuve un essai clinique pour une thérapie contre le cancer de l’ovaire
Par Bruno Quinney, 24 avril 2026
Cet article continue en anglais...
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved a clinical trial application for a therapy targeting advanced high-grade serous ovarian cancer.
CryptiVax-1001, developed by biotechnology company Epitopea, is an off-the-shelf mRNA therapeutic vaccine. It is designed to drive targeted immune responses using a set of tumour-specific antigens chosen for broad patient coverage.
The OVACT Phase I/Ib dose escalation and expansion trial will evaluate the safety, tolerability, immunogenicity, and early clinical activity of CryptiVax-1001 in HRP+/BRCA-wildtype high-grade serous ovarian cancer patients.
The trial will be led by Chief Investigator Professor 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.
“There is a substantial unmet need in homologous recombination proficient (HRP) ovarian cancer, where available maintenance therapies deliver limited durable benefit,” Banerjee said.
“Epitopea’s CryptiVax-1001 vaccine, which targets a novel repertoire of tumour-specific antigens, has the potential to meaningfully extend remission for patients with few effective treatment options.”
“We are excited by the achievement of this significant regulatory milestone, which is a credit to our dedicated clinical and wider Epitopea team,” added Dr Klaus Edvardsen, Chief Medical Officer of Epitopea.
“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.”
