Cancer vaccine trial underway

Regenerative medicine company Regeneus (ASX:RGS) yesterday announced that the first patient has been enrolled and treated in a clinical trial of the company’s autologous tumour vaccine, RGSH4K.

RGSH4K is produced from a patient’s own cancer cells and is an immunostimulant that is designed to activate the immune system against the cancer cells to initiate a body-wide response. The cancer vaccine technology was developed at the Bill Walsh Translational Cancer Research Laboratory, which is part of the Kolling Institute of Medical Research and is the research arm of the Department of Medical Oncology at Royal North Shore Hospital.

To facilitate the new trial — a first-in-human, phase 1, dose-escalating study to evaluate the safety, tolerability and preliminary efficacy of RGSH4K — Regeneus established an ethics-approved tumour bank. Participants stored a tumour sample in order to produce an autologous cancer vaccine for each individual patient’s use in the trial.

A review of the first patient’s safety data by the study safety oversight committee identified no safety concerns. Enrolment has thus been opened to three different dose cohorts comprising seven patients each, for a total of 21 patients. Patients will be on study for 24 weeks, with an option to continue dosing and long-term follow-up in an open-ended extension phase.

“We are pleased to see no safety concerns from the first treated patient,” said Professor Stephen Clarke, a medical oncologist from the University of Sydney’s Northern Clinical School at the Kolling Institute and one of the principal investigators of the study. “We are now focusing on enrolling more patients for this novel therapy.”

Regeneus (ASX:RGS) shares were trading 8.70% higher at $0.125 as of around 3.30 pm on Wednesday.