Regeneus Ltd. said its RGSH4K cancer vaccine met its main goal of safety and tolerability in an early stage trial.
RGSH4K is a vaccine made from the patient's own cancer cells, combined with an immunostimulant. It is designed to activate the immune system against the cancer cells and trigger a body-wide response.
The phase 1 study, dubbed Activate, evaluated the safety and tolerability of RGSH4K in 12 patients who had various advanced solid tumors and were heavily pretreated with chemotherapy or radiotherapy.
In the study, the patients received three vaccines within three dose groups during treatment phase, at 3-week intervals and an optional extension phase.
Regeneus said the vaccine also demonstrated anti-tumor activity and initiated immune response in some of the patients, as shown by the changes in cancer markers such as immune cells and cytokines.
The Australian regenerative medicine company intends to further develop the vaccine in future studies.