Regeneus (ASX:RGS) has announced results from the phase 1 safety trial of its cancer vaccine, confirming RGSH4K met the primary endpoint of safety and tolerability.
RGSH4K is the company's autologous tumour vaccine product for the treatment of solid tumours.
The vaccine is produced from a patient's own cancer cells and, combined with an immunostimulant, is designed to activate the immune system against the cancer cells to initiate a body-wide response.
The single centre, open-label, first-in-human phase 1 ACTIVATE trial was designed to evaluate the safety and tolerability of RGSH4K and to identify the biologically active dose and doses to take into future trials.
The trial's 12 patients were heavily pretreated with chemotherapy or radiotherapy and had various advanced solid tumours. They received RGSH4K in 3 dose cohorts.
A total of three vaccines were administered in the treatment phase. They were given at three-week intervals and patients had the option to continue dosing in an extension phase.
All dose levels were safe and well tolerated, said the company, achieving the safety primary endpoint.
"There were no dose limiting toxicities and no serious adverse events related to the vaccine. Injection site reactions were the most common adverse event related to RGSH4K administration," it said.
"RGSH4K also showed encouraging signs of immune stimulation in some patients, as demonstrated by changes in cancer markers, immune cells and cytokines. This immune stimulation was seen in one or more patients at all three dose levels. Preliminary indications of anti-tumour activity were seen in some patients however long term follow up on 50% of the patients continues."
The trial's principal investigators are medical oncologists Professor Stephen Clarke and Associate Professor Nick Pavlakis from University of Sydney's Northern Clinical School at the Kolling Institute of Medical Research. The trial was conducted through the Northern Cancer Institute.
"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," said Professor Clarke.
According to Regeneus CEO John Martin, "Data obtained from this first-in-human clinical study, including the preliminary evidence of clinical activity, is encouraging and highlights the clinical potential of RGSH4K. We are pleased with these results and we will use them to advance further studies and our partnering discussions with interested parties."