- Imugene has been granted a core Japanese patent that protects the Company’s HER-Vaxx immunotherapy.
- HER-Vaxx immunotherapy is currently under development for HER2 positive gastric cancer.
- The patent protects the method of use and method of composition of HER-Vaxx to 2036.
Shares of immuno-oncology player Imugene Limited (ASX:IMU) rose as much as 6.6% to AU$0.485 during the morning trading session of 22 September 2021 following an encouraging update on HER-Vaxx immunotherapy. The shares continued to be in the green zone on 23 September, trading at A$0.475, up 1% (10:25 AM AEST).
Imugene has been granted a core Japanese patent in the major HER2 positive gastric cancer market, which protects the Company’s HER-Vaxx immunotherapy.
The Company’s advanced B-cell activating immunotherapy, HER-Vaxx, has been designed to treat tumours that over-express the HER-2/neu receptor, like breast, ovarian, gastric, lung and pancreatic cancers. The immunotherapy HER-Vaxx is constructed from multiple B cell epitopes, which are derived from the extracellular domain of a well-known & validated cancer target - HER-2/neu. In pre-clinical, Phase I and Phase 2 trials, HER-Vaxx has been shown to encourage a potent polyclonal antibody response to HER-2/neu receptor.
Details of new patent
Imugene informed that it has received a Notice of Grant for Patent Application number 2018-505505 from the Japanese Patent Office. This patent protects the Company’s HER-Vaxx immunotherapy, which is presently under development for HER2 positive gastric cancer.
The patent is titled “A VACCINE COMPOSITION AND USES THEREOF” (inventor Professor Dr Ursula Wiedermann from the Medical University Vienna). Moreover, the patent protects the method of use and method of composition of the Company’s HER-Vaxx immunotherapy to 2036.
Imugene highlighted that around 75 per cent of all gastric cancer diagnoses are in Asia. Notably, Japan has the 3rd highest incidence rate of gastric cancer across the globe, of which about one in five cases are deemed to be HER2 positive. This makes Japan a very huge market for gastric cancer medications.
HER-Vaxx Phase 2 gastric cancer trial
Imugene is conducting an open-label Phase 2 gastric cancer study of HER-Vaxx to evaluate the efficacy, immune response, and safety in metastatic gastric cancer that overexpresses the HER-2 protein.
In the Phase 2 trial, the patients are randomly divided into two groups of either HER-Vaxx plus standard chemotherapy or only standard chemotherapy. Moreover, the study is being carried out in Asia and Eastern Europe, where trastuzumab supplies are limited.
The primary endpoint of the trial is overall survival, with safety and progression-free survival (PFS) being the secondary endpoints. The immune-related endpoints of the study include randomized values and changes from randomization in cellular and humoral immunogenicity data. Imugene has recruited 36 patients for the HER-Vaxx trial, of which 24 have achieved PFS events in this signal generating study.
Imugene is currently waiting for the events needed for OS (Overall Survival) evaluation. The Company will subsequently evaluate all data comprising final OS, PFS, safety, and immune responses. The immuno-oncology player has further planned two company-sponsored Phase 2 trials & one Investigator Sponsored Study with HER-Vaxx in late-stage and early gastric cancer.