Immuno-oncology company Nouscom disclosed on Monday that its Investigational New Drug (IND) application for the first phase 1 clinical trial of its lead candidate NOUS-209 has passed US Food and Drug Administration (FDA) approval.

According to the company, NOUS-209 is an off-the-shelf therapeutic cancer vaccine based on shared frame-shift neoantigens.

The company will now launch a phase 1 clinical trial of the therapeutic vaccine NOUS-209 for gastric, colorectal and gastro-esophageal junction Microsatellite Instable (MSI) cancers (tumours characterised by a defective DNA mismatch repair system) in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab.

Under the phase 1 trial, the company will enrol up to 30 patients across several US clinical centres in the the third quarter of 2019. Initial clinical data are expected in early 2020.

In conjunction, the primary objective of the study is to demonstrate safety and tolerability of the combination regimen, evaluate vaccine-induced immune responses, as well as the preliminary signs of anti-tumour activity in enrolled patients.

Based on preclinical data, NOUS-209 is expected to induce potent and broad CD8+ and CD4+ responses in humans, concluded the company.