Imugene Limited (ASX:IMU) (OTCMKTS:IUGNF) has completed recruitment to the Phase 2 trial of its B-cell activating immunotherapy HER-Vaxx in Her-2/Neu overexpressing advanced/metastatic gastric/GEJ cancer.
The Phase 2 trial represents a clinical proof-of-concept for HER-Vaxx to indicate that B-cell activating immunotherapy platform can induce clinically active antibody responses.
It is being conducted at sites across Asia, Eastern Europe and India where clinicians and patients have difficulty accessing treatments and there is a high prevalence of gastric cancer.
"Important achievement"
Managing director and CEO Leslie Chong said: “I am excited to report that we have completed recruitment in the HER-Vaxx Phase 2 clinical trial.
“This is an important achievement for Imugene and the many medical professionals seeking treatments for patients with advanced gastric cancer who often have very few medical options.
“I look forward to completing the study and updating the market with clinical trial results.”
Independent committee guidance
Completion of recruitment follows the recent Independent Data Monitoring Committee (IDMC) review of HER-Vaxx Phase 2 interim analysis safety and efficacy data where the IDMC reported no safety concerns and viewed this preliminary data as strongly in favour of a HER-Vaxx survival effect.
The IDMC provided guidance that it is scientifically and ethically appropriate to reduce the overall number of patients required to complete the study given the strong signal observed in the data.
Following this guidance, Imugene reduced the overall number of patients required to complete the study to 36 patients - all of which have now completed their baseline visit.
HER-Vaxx Phase 2 trial
HER-Vaxx is designed to produce an antibody response against a cancer growth signal receptor protein called HER-2 found on the cell surface in breast and gastric cancers.
The Phase 2 study will test the efficacy, safety and immune response in gastric cancer patients with metastatic gastric cancer overexpressing the HER-2 protein.
Patients will be randomised patients 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.