Epitopea doses first patient in OVACT ovarian cancer vaccine trial

Trial scope for HRP-positive and BRCA-wildtype patients

Researchers plan to enroll up to 30 women across as many as 10 clinical centres located in the United Kingdom.

Eligibility for the trial is restricted to patients with advanced high-grade serous ovarian cancer whose tumours meet specific genetic criteria. These patients must be HRP-positive and BRCA-wildtype to participate in the study.

CryptiVax™-1001 and dark genome technology

CryptiVax™-1001 is an mRNA-based treatment developed by Epitopea to address advanced ovarian cancer. The company uses a proprietary discovery engine called CryptoMap™ to identify tumor-specific antigens known as Cryptigens™ from the dark genome.

These antigens are designed to stimulate an immune response against the cancer. Because these antigens are shared across multiple patients, the company can develop these vaccines as off-the-shelf treatments. This approach removes the need to manufacture individual treatments for each patient.

Addressing the therapeutic gap in HGSOC

It is considered a difficult-to-treat solid tumor.

While most women respond to initial platinum-based chemotherapy, nearly all patients eventually experience recurrence. Patients frequently progress to platinum-resistant disease following this relapse.

Existing maintenance therapies for ovarian cancer are effective in only half of the patient population. This limitation creates a therapeutic gap for HRP-positive and BRCA-wildtype patients.

Expert leadership and clinical commentary

She acts as the Chief Investigator for the OVACT trial.

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". She added, "The CryptiVax™-1001 vaccine has the potential to meaningfully extend remission for women where currently available maintenance therapies deliver limited durable benefit".

Klaus Edvardsen, the Chief Medical Officer of Epitopea, said, "HGSOC is the most common and aggressive subtype of ovarian cancer". He noted that "Treating the first patient with CryptiVax™-1001 in our OVACT Phase 1/1b trial for HGSOC is a major milestone for Epitopea".

Edvardsen said, "Epitopea’s approach targets a novel repertoire of tumour-specific antigens that have been selected to provide broader patient benefit". He also said, "We are motivated by the potential to provide meaningful durable treatment options for this underserved patient population".

Epitopea company profile

Epitopea is a clinical-stage biotech company that develops off-the-shelf RNA-based cancer vaccines. The company operates from locations in Cambridge, UK, and Montreal, Canada.

Its research and development focus is on creating RNA-based immunotherapies for solid tumours.

Early clinical development status

The clinical trial is a Phase 1 study evaluating the safety and early effectiveness of the vaccine. The treatment is currently in early clinical development.

Its safety and effectiveness in patients have not yet been established.