Epitopea receives MHRA approval for first-in-human trial of RNA vaccine for ovarian cancer
The company has received regulatory approval from the MHRA and Regional Ethics Committee to initiate its OVACT Phase I/Ib clinical trial of CryptiVax-1001, an off-the-shelf mRNA immunotherapy targeting high-grade serous ovarian cancer.
Biotech company Epitopea has 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 first-in-human clinical trial (OVACT) of its lead programme, CryptiVax-1001, targeting advanced high-grade serous ovarian cancer.
The firm also announced the appointment of Professor Susana Banerjee from The Royal Marsden NHS Foundation Trust as Chief Investigator of the OVACT trial.
Dr Klaus Edvardsen, Chief Medical Officer of Epitopea, 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.”
OVACT is a Phase I/Ib trial that will evaluate the safety, tolerability, immunogenicity and early clinical activity of CryptiVax-1001 in HRP+/BRCA-wildtype patients with high-grade serous ovarian cancer (HGSOC).
HGSOC is a challenging solid tumour, with around 80% of patients presenting at an advanced or metastatic stage.
While many respond to initial platinum chemotherapy, most ultimately relapse and become platinum-resistant.
There is a significant therapeutic gap for HRP+/BRCA-wildtype patients, who represent about 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 targets novel tumour-specific antigens and, the company says, may significantly extend remission for patients with limited treatment options.
Powered by CryptoMap, a proprietary discovery engine, the firm identifies tumour-presented antigens from the dark genome. These high-sharing antigens, known as Cryptigens, then enable the development of off-the-shelf mRNA immunotherapies.
