Imugene (ASX:IMU), an immuno-oncology company, has announced the commencement of a Phase 1b/2 clinical study of its HER-Vaxx therapy in gastric cancer.
HER-Vaxx is a next generation HER-2 cancer therapy using B cell peptides, which harness the body’s ability to develop antibodies against the disease.
Gastric cancer patients will now be screened and enrolled at eight key cancer hospital sites in Asia, including Hong Kong, Thailand and Taiwan.
The Phase 1b/2 study will be conducted in two parts, said the company.
Phase Ib is an open-label, multi-centre dose escalation study, designed to assess the safety, tolerability and immunogenicity. The trial will enrol up to 18 patients, who will be treated with HER-Vaxx in combination with chemotherapy to interrogate three dose levels. This stage will also evaluate the booster schedule to help determine optimal recommended dosing for Phase 2.
The larger open label Phase 2 study will recruit 68 patients with metastatic gastric cancer over-expressing HER2. This study will be randomised into two arms of either HER-Vaxx plus standard-of-care (chemotherapy) or standard-of-care alone. HER-Vaxx works by targeting the same receptor as the Roche therapies, Herceptin and Perjeta, two of the leading antibody drugs on market, with annual sales of US$8.2 billion.
Since completion of Phase 1, Imugene said it has optimised the formulation of HER-Vaxx, enhancing the vaccine’s potency ten-fold, enabling a faster immune response and lowering the cost of goods.
The company's Chief Operating Officer, Leslie Chong, said: “This is a significant milestone for Imugene and gastric cancer patients, especially across South East Asia. Accomplishing this goal speaks to the perseverance and dedication of Imugene’s team as we continue to build on our significant clinical and commercial potential.
“We are confident that HER-Vaxx could fill a significant unmet medical need in gastric cancer, particularly in Asia,” added Ms Chong.