Targovax announces that it has recruited the first patient in an exploratory Phase Ib clinical trial of TG02 in patients with locally recurrent RAS-mutated rectal cancer scheduled to have surgery.
The trial is being conducted at clinical sites in Australia and New Zealand.
In this open label, non-randomized trial, ten patients will receive TG02 as monotherapy and then followed by ten patients receiving TG02 in combination with pembrolizumab, a PD-1 checkpoint inhibitor. The trial’s primary objective is to investigate the safety and immune activity in peripheral blood and at the tumor level.
TG02 is the second TG cancer immune activator to enter the clinic from the Company’s peptide-based immunotherapy platform. It contains a proprietary mixture of eight synthetic peptides representing fragments of the most frequent RAS mutations seen in rectal cancer. Studies to date have shown that the Company’s lead immune activator for RAS-mutated cancer, TG01, induces immune responses in cancer patients with resected pancreatic cancer, which may translate clinically to a survival benefit. Mutations in RAS, a family of structurally related proteins that regulate cell growth, are seen in about 50% of colorectal cancers, and nearly all patients with recurrent disease. They are associated with a limited response to chemotherapy and poor prognosis. Previous and ongoing clinical studies have shown that TG peptides are able to induce RAS mutation specific immune responses. Targovax is the only company with RAS-mutated specific immune activators in clinical development.
Magnus Jaderberg MD, Chief Medical Officer at Targovax said, “We are excited to have initiated this study in patients with locally recurring RAS-mutated rectal cancer. This will be the first time our TG02 immune activator will be tested in humans and, while the study’s primary objective is to study safety, we will also be looking at signs of anti-tumour immune activation, thus providing important mechanistic data not just for TG02 but for the entire TG technology platform. In addition, it will give us an indication on how this novel immunotherapy can be enhanced in combination with a checkpoint inhibitor.”