Epitopea doses first patient in UK ovarian cancer vaccine trial

The first patient has received an experimental ovarian cancer vaccine in a UK clinical trial assessing its safety and early signs of effectiveness.

The Phase 1/1b study will enrol up to 30 women with advanced high-grade serous ovarian cancer (HGSOC) at up to 10 clinical centres across the UK.

Researchers will assess the vaccine’s safety, tolerability and ability to trigger an immune response, alongside early signs of clinical activity.

The trial is being led by professor Susana Banerjee, 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, London.

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.”

Biotechnology company Epitopea announced that the first patient had received CryptiVax™-1001, its lead RNA-based cancer vaccine, in the OVACT trial.

The first-in-human study will test increasing doses of the treatment in women with advanced HGSOC whose tumours meet the trial’s HRP-positive and BRCA-wildtype genetic criteria.

According to Epitopea, HGSOC is the most common and aggressive subtype of ovarian cancer.

Around 80 per cent of patients present with advanced or metastatic disease, meaning the cancer has reached an advanced stage or spread to other parts of the body.

Although most women initially respond to first-line platinum-based chemotherapy, nearly all eventually experience a recurrence and develop resistance to treatment.

Epitopea said existing maintenance therapies, which aim to prevent or delay cancer returning after initial treatment, are effective in approximately half of the ovarian cancer population.

The company is developing CryptiVax™-1001 to address the treatment gap among patients with HRP-positive, BRCA-wildtype disease.

The vaccine is designed to stimulate an immune response against tumour-specific antigens, molecular targets that the immune system can recognise.

These targets are identified using Epitopea’s CryptoMap technology, which detects antigens originating from regions of genetic material known as the dark genome.

The company says the antigens are shared across multiple patients, potentially allowing vaccines to be developed without manufacturing a separate treatment for each individual.

Dr Klaus Edvardsen, chief medical officer of Epitopea, said: “HGSOC is the most common and aggressive subtype of ovarian cancer.

“Treating the first patient with CryptiVax™-1001 in our OVACT Phase 1/1b trial for HGSOC is a major milestone for Epitopea. Epitopea’s approach targets a novel repertoire of tumour-specific antigens that have been selected to provide broader patient benefit.

“We are motivated by the potential to provide meaningful durable treatment options for this underserved patient population.”

The treatment remains at an early stage of clinical development. Its safety and effectiveness in patients have yet to be established.

Epitopea, which operates from Cambridge in the UK and Montreal in Canada, is developing RNA-based immunotherapies for solid tumours, including cancers with limited durable treatment options.