First patient dosed in phase 2 trial with Imugene’s gastric cancer vaccine

By Meagan Evans. Published at Mar 14, 2019, in Biotech

Clinical stage immuno-oncology company, Imugene Limited (ASX:IMU), today announced dosing of the first patient in a in 68 patient randomised Phase 2 HER-Vaxx cancer trial.

HER-Vaxx is a potentially ground-breaking cancer vaccine designed to produce an antibody response against a cancer growth signal receptor protein called HER-2 which is found on the cell surface of multiple cancers including breast and gastic cancers.

The open-label, randomised multi-centre Phase 2 study with its HER-Vaxx (IMU-131) cancer vaccine for the treatment of HER-2 positive gastric cancer patients saw the first patient dosed at the Oncological Institute in Chisinau, the capital of Moldova, in Eastern Europe.

This latest trial is being conducted at multiple sites across Asia, Eastern Europe and India where patients have difficulty accessing approved antibody treatments such as Herceptin and Perjeta marketed by Swiss multinational Roche Holding AG. There is also a high prevalence of gastric cancer in the countries selected.

Two Eastern European sites are now actively recruiting patients, with approval imminent for trial sites in Hong Kong, Taiwan, Thailand and India.

The Phase 2 study is designed to measure the efficacy, safety and immune response in 68 patients with metastatic gastric cancer overexpressing the HER-2 protein. It is randomised into two arms of either HER-Vaxx plus standard-of-care chemotherapy or standard-of care alone.

The primary endpoint is overall survival and secondary endpoint will be progression-free survival. Safety, tolerability and immune response will also be measured.

The prior Phase 1b HER-Vaxx study reported no safety or toxicity issues, while all evaluable patients showed increased antibody responses. One patient saw a complete response, five had a partial response and four recorded a stabilisation of their disease.

Imugene Managing Director and Chief Executive Officer Leslie Chong said, “There is strong medical investigator interest following the good results seen in the recently completed Phase 1b trial, where 11 out of 14 evaluable patients showed clinically meaningful responses. We look forward to providing regular recruitment updates as the Phase 2 study moves toward completion in 2020.”

“The start of the Phase 2 study is an important milestone for Imugene and the many medical professionals seeking treatments for patients with advanced HER-2 positive gastric cancer who often have very few medical options.”

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