Biotechnology company Epitopea has announced that the first patient has received its experimental cancer vaccine, CryptiVax™-1001, in a Phase 1/1b clinical trial investigating a potential new approach to treating advanced high-grade serous ovarian cancer.
The trial, known as OVACT, is the first human clinical study of the company’s lead vaccine candidate. It will evaluate the treatment in women with advanced high-grade serous ovarian cancer who have homologous recombination proficient (HRP-positive) and BRCA-wildtype tumours, a patient group with limited options for long-term disease control.
The study will enrol up to 30 women across as many as 10 clinical centres in the United Kingdom. Researchers will assess the vaccine’s safety, tolerability and ability to stimulate an immune response, alongside early indicators of clinical activity.
The trial is led by Professor Susana Banerjee, Consultant Medical Oncologist and Research Lead for the Gynaecology Unit at The Royal Marsden NHS Foundation Trust. She is also Professor in Women’s Cancers at The Institute of Cancer Research in London.
Commenting on the milestone, Professor Banerjee said:
“It is exciting to offer patients the option of the OVACT trial and I am delighted that we are underway with the first patient treated. The CryptiVax™-1001 vaccine has the potential to meaningfully extend remission for women where currently available maintenance therapies deliver limited durable benefit.”
High-grade serous ovarian cancer is the most common and aggressive subtype of ovarian cancer. According to Epitopea, around 80 per cent of patients are diagnosed with advanced or metastatic disease. Although many women initially respond to platinum-based chemotherapy, recurrence and the development of treatment resistance remain significant challenges.
CryptiVax™-1001 is an experimental RNA-based therapeutic cancer vaccine designed to stimulate the immune system to recognise and attack tumour-specific targets. Its development is supported by Epitopea’s proprietary CryptoMap technology, which identifies tumour-associated antigens originating from regions of the genome sometimes referred to as the dark genome.
These targets, known as Cryptigens, are selected for their ability to stimulate immune responses and their potential to be shared across different patients. This approach is intended to support the development of off-the-shelf cancer vaccines rather than requiring an individually manufactured treatment for every patient.
Dr Klaus Edvardsen, Chief Medical Officer of Epitopea, described the first patient dosing as a major milestone for the company, highlighting the potential of its approach to address an underserved patient population.
Epitopea operates from Cambridge in the United Kingdom and Montreal in Canada. The company is developing RNA-based immunotherapies for difficult-to-treat solid tumours, with the aim of creating treatments that can be made available to broader groups of patients.
The start of the OVACT trial represents an important step in translating the company’s research into clinical development. However, CryptiVax™-1001 remains experimental, and the study will need to establish its safety and assess whether it can deliver meaningful clinical benefits.
For women affected by advanced ovarian cancer, the research adds to ongoing efforts to develop more durable treatment options and address areas of unmet need in gynaecological oncology.
