- Imugene Limited (ASX:IMU) recently presented promising data on the HER-Vaxx cancer immunotherapy program at the ESMO World Congress on Gastrointestinal Cancer 2021 Annual Meeting.
- At the event, the Company expanded on previously presented interim analysis data presented at American Association for Cancer Research (AACR) 2021.
- The latest data reveals that the reduction of tumour size is significantly higher in patients that received HER-Vaxx plus chemotherapy.
Imugene Limited (ASX:IMU), an Australia-based clinical stage immuno-oncology firm, recently presented on its HER-Vaxx cancer immunotherapy program at the ESMO World Congress on Gastrointestinal Cancer 2021 Annual Meeting.
The abstract presentation delivered by Imugene was entitled as:
The presentation focused on the Company’s HER-Vaxx cancer immunotherapy, which has been designed to treat tumours overexpressing the HER-2/neu receptor, such as breast, ovarian, gastric, pancreatic and lung cancers. In pre-clinical as well as Phase 1 and 2 studies, HER-Vaxx has been shown to stimulate a potent polyclonal antibody response to HER-2/neu receptor, which is a validated and well-known cancer target.
Fundamental details of presentation
In the ESMO World Congress on Gastrointestinal Cancer’s Annual Meeting, Imugene expanded on previously presented interim analysis data presented at American Association for Cancer Research (AACR) 2021.
The Company highlighted and presented the following new data in the ESMO presentation:
- HER-Vaxx treatment resulted in a 50 per cent Overall Response Rate (ORR) relative to 29 per cent in patients treated with chemotherapy alone.
- Treatment with HER-Vaxx clearly shows that patients develop high levels of HER2-specific antibodies early in the treatment protocol. These antibodies are maintained during the treatment and maintenance phase with just a few booster injections.
- The tumour response and the amount of antibody levels are correlated. Patients with antibody levels greater than 1050ng/ml received higher than 50 per cent tumour reduction and may serve as a prospective biomarker.
- In comparison to patients on chemotherapy alone, the reduction of tumour size is significantly higher in patients that received HER-Vaxx plus chemotherapy.
Know about Phase 2 HER-Vaxx study
In Phase 2 study of HER-Vaxx, patients are randomized into two arms of either HER-Vaxx plus standard chemotherapy or standard chemotherapy alone. The study was designed to measure the efficacy, safety, and immune response in patients with late stage, metastatic or advanced gastric cancer.
The study is conducted in countries with limited access to trastuzumab in Asia and Eastern Europe. Patients in these regions have difficulty accessing the currently available antibody treatments Herceptin® and Perjeta®, and the level of gastric cancer in these countries is high due to diet and nutritional issues.
The primary endpoint of the study is overall survival, with progression-free survival and safety as secondary endpoints. Immune-related endpoints include values and changes from randomization in humoral and cellular immunogenicity data.
Interestingly, interim analysis in the randomized Phase 2 trial of HER-Vaxx showed a positive Overall Survival Hazard Ratio. Besides, the secondary clinical endpoint of Progression Free Survival (PFS) was also recently met in the Phase 2 trial, with top-line data expected this year.
Overall, the recently presented data at ‘ESMO World Congress on Gastrointestinal Cancer’ shows HER-Vaxx may provide treatment benefits in line with traditional monoclonal antibodies with a corresponding adaptive immune response with no added toxicity.
Imugene shares closed the trading session at AU$0.350 as of 5 July 2021.