Updated on 6 June 2016
NASDAQ-listed Targovax has received approval in Australia to conduct a study with TG02 and pembrolizumab, a checkpoint inhibitor, in patients with locally recurrent RAS mutated rectal cancer.
TGO2 is a cancer vaccine containing a mixture of 8 synthetic peptides representing fragments of the most common RAS mutations seen in colorectal cancer disease.
Mutations in RAS a protein regulating cell growth is seen in about 50% of patients with colorectal cancer and 20-30% of all cancers. It is associated with a lack of 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 research organization with RAS mutated specific vaccines at clinical development stage. This will be the first study with TG02 in humans and 20 patients will be included at Australian sites, say the press release.
The study will assess safety and immune activation, both at lesional level and in peripheral blood. One cohort will only receive TG02 and another cohort will receive TG02 in combination with pembrolizumab, a PD-1 receptor inhibitor.
"We have already shown in other indications that TG peptides can induce specific immune responses and that these are associated with clinical benefits. However, this study will take us one step further in assessing immune activation at tumor level. It will also give us an indication on how our immune therapy may be enhanced when combining with a check point inhibitor," said Magnus Jaderberg, CMO at Targovax.