IND for NOUS-209, an ‘off-the-shelf’ Neoantigen Cancer Vaccine, Cleared by FDA to Commence Clinical Development in MSI Solid Tumors

BASEL, Switzerland – 3rd June 2019: Nouscom, an immuno-oncology company developing off-the-shelf and personalized cancer neoantigen vaccines, announced today that its Investigational New Drug (IND) application for the first clinical trial of its lead candidate NOUS-209 has been cleared by the US Food and Drug Administration (FDA).

The Company will proceed with its plans to conduct a phase 1 clinical trial of NOUS-209, a therapeutic vaccine for gastric, colorectal, and gastro-esophageal junction Microsatellite Instable (MSI) cancers (tumors characterized by a defective DNA mismatch repair system) in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab. The trial will be enrolling up to 30 patients across several US clinical centers and is expected to begin during the third quarter of 2019. Initial clinical data are expected in early 2020.

The primary objective of the study is to demonstrate the safety and tolerability of the combination regimen. Additionally, the study will evaluate vaccine-induced immune responses, as well as preliminary signs of anti-tumor activity in enrolled patients. Based on preclinical data, NOUS-209 is expected to induce potent and broad CD8+ and CD4+ responses in humans.

“The clearance of our IND application to evaluate NOUS-209 in combination with pembrolizumab is a significant milestone,” said Dr. Marina Udier, CEO a.i. of Nouscom AG. “NOUS-209 leverages a core strength of Nouscom’s platform, namely the capacity of its proprietary viral vectors, Great Ape Adenovirus and Modified Vaccinia Ankara, to encode a large number of neoantigens. As such, NOUS-209, comprising a collection of 209 Frame Shift Peptides (FSPs) selected with a proprietary algorithm, is designed to have broad coverage in the targeted patient populations, without the need to preselect patients for treatment. Hence NOUS-209 has the potential to be the first universal cancer neoantigen off-the-shelf vaccine in MSI solid tumors. We look forward to trial initiation and study results.”