Nouscom – First Patient Dosed in a Phase 1 Trial with NOUS-209, an ‘off-the-shelf’ Neoantigen Cancer Vaccine, in MSI-High Solid Tumors
BASEL, Switzerland – 9 December 2019: Nouscom, an immuno-oncology company developing off-the-shelf and personalized cancer neoantigen vaccines, announced today that the first patient has been dosed in a Phase 1 clinical trial evaluating its lead candidate, NOUS-209. In this first-in-human trial NOUS-209, an off-the-shelf therapeutic vaccine based on shared tumor neoantigens, is being administered to patients with Microsatellite Instable High (MSI-H) gastric, colorectal and gastro-esophageal junction cancers (tumors characterized by a defective DNA mismatch repair system) in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab.
NOUS-209-01 (NCT04041310) is a US multicenter Phase 1 open-label, dose-escalation study, assessing the safety and tolerability of the NOUS-209 vaccine in combination with pembrolizumab to determine the recommended Phase 2 dose. 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. Initial clinical data are expected in 2020.
Dr. Michael J. Overman, Principal Investigator of the trial and Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center, explained: “We have seen tremendous change in our approach to MSI-high metastatic solid tumors over the last few years, but the majority of patients do not respond to single agent immunotherapy. Hence, further optimization of our approach for MSI-high cancers is needed. Agents like NOUS-209 that stimulate the patient’s immune response and direct it specifically against the cancer cells reflect a tremendous scientific evolution in our understanding of these cancers and represents an extremely promising approach for these cancers.”
Dr. Elisa Scarselli, Chief Scientific Officer and Co-Founder of Nouscom, said “This first-in-human trial evaluating NOUS-209 in combination with pembrolizumab is a significant milestone for Nouscom. NOUS-209 leverages a core strength of the company’s platform, namely the capacity of its proprietary viral vectors to encode a large number of neoantigens. NOUS-209 was named because it comprises 209 shared Frame Shift Peptides (FSPs) selected using a proprietary algorithm. This feature of NOUS-209 enables it to be developed as an off-the-shelf neoantigen vaccine that does not require patient screening prior to treatment. Furthermore, it is designed to have broad coverage across the MSI patient population by targeting multiple neoantigens in each patient, and as such is expected to address tumor heterogeneity. We look forward to the initial clinical data in 2020.”