Regeneus has reported positive results from the ACTIVATE trial, which met its primary endpoint of safety and tolerability for RGSH4K to treat tumours.
ACTIVATE is a Phase I study of RGSH4K vaccine for the treatment of solid tumours.
The single centre, open-label and first-in-human trial was carried out to examine the safety and tolerability of RGSH4K and identify the biologically active doses to take into future trials.
During the trial, 12 patients heavily pretreated with chemotherapy or radiotherapy with various advanced solid tumours were split into three dose cohorts to receive RGSH4K.
Altogether three vaccines were given in the treatment phase at three-week intervals, while patients had the option to continue dosing in an extension phase.
It was reported that all the dose levels were safe and well-tolerated, allowing the trial to achieve its safety primary endpoint.
No dose-limiting toxicities and no serious adverse events related to the vaccine were reported during the trial.
The most common adverse events were injection site reactions.
In addition, RGSH4K demonstrated encouraging signs of immune stimulation in some patients, as shown by changes in cancer markers, immune cells, and cytokines.
Preliminary indications of anti-tumour activity were also observed in some patients. However, long-term follow-up on 50% of the patients continues.
One of the principal investigators of the trial professor Stephen Clarke said: “The immune response, including favourable changes in biomarkers, coupled with the benign safety profile for RGSH4K encourages proceeding to further clinical evaluation either as a single agent or in combination with other therapies.”
Regeneus has developed RGSH4K using a patient’s own cancer cells, as well as combined with an immunostimulant.
The vaccine is designed to activate the immune system against the cancer cells to set off a bodywide response.