Epitopea has secured approval from the Medicines and Healthcare products Regulatory Agency (MHRA) and the Regional Ethics Committee (REC) in the UK for its OVACT clinical trial application (CTA) targeting advanced high-grade serous ovarian cancer.
The first-in-human trial will evaluate the lead programme, CryptiVax-1001, a ribonucleic acid (RNA)-based immunotherapeutic vaccine.
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The company has also confirmed The Royal Marsden NHS Foundation Trust Gynaecology Unit Consultant Medical Oncologist and Research Lead, and Institute of Cancer Research Professor in Women’s Cancers Susana Banerjee as chief investigator of the OVACT trial.
Epitopea chief medical officer Dr Klaus Edvardsen said: “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.”
The OVACT Phase I/Ib trial is structured to assess immunogenicity, tolerability, safety, and early clinical data of CryptiVax-1001 in patients with homologous recombination proficient (HRP) / BRCA-wildtype high-grade serous ovarian cancer.
This patient group has few effective treatment options, as nearly 80% present with advanced or metastatic disease and most relapse after initial platinum chemotherapy.
Banerjee continued: “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 tumour-specific antigens, has the potential to meaningfully extend remission for patients with few effective treatment options.”
The company’s technology platform, CryptoMap, identifies tumour-presented antigens, named Cryptigens, from the dark genome. These are shared across patients, providing a foundation for developing off-the-shelf mRNA immunotherapies.
Epitopea’s focus lies in deploying RNA-based immunotherapies for hard-to-treat solid tumours, with CryptiVax-1001 advancing as an off-the-shelf mRNA vaccine engineered to provide broad patient applicability.
