Nouscom Announces Clinical Trial Collaboration and Supply Agreement with MSD to Evaluate NOUS-209 in combination with KEYTRUDA® (pembrolizumab) in a Phase 2 Randomized Trials in dMMR/MSI-High Metastatic Colorectal Cancer

Nouscom Announces Clinical Trial Collaboration and Supply Agreement with MSD to Evaluate NOUS-209 in combination with KEYTRUDA^® (pembrolizumab) in a Phase 2 Randomized Trials in dMMR/MSI-High Metastatic Colorectal Cancer

BASEL, Switzerland – 5^th January 2023 - Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized immunotherapies, today announced that it has entered into a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), to evaluate Nouscom’s wholly-owned lead candidate, NOUS-209, in combination with MSD’s anti-PD-1 therapy KEYTRUDA^® (pembrolizumab) versus KEYTRUDA alone in randomized Phase 2 trials in patients with Mismatch Repair/Microsatellite Instable High (dMMR/MSI-H) Metastatic Colorectal Cancer (CRC).

NOUS-209 is an off-the-shelf immunotherapy targeting 209 specific, shared neoantigens found in dMMR/MSI-H unresectable or metastatic gastric, colorectal and gastro-esophageal junction tumors.

The Phase 2 study includes two cohorts in dMMR/MSI-H unresectable and metastatic CRC assessing the efficacy and safety of NOUS-209 in combination with pembrolizumab at multiple active sites across Europe and the US (NCT04041310).

1. A randomized cohort enrolling patients who are eligible for first line treatment, randomized 2:1 to NOUS-209 plus pembrolizumab versus pembrolizumab alone;
2. A single arm cohort enrolling patients who have stopped responding to previous anti-PD1 treatment.

Dr Marina Udier, Chief Executive Officer of Nouscom, added: “We are thrilled to collaborate with MSD, a global leader in immuno-oncology, and to work with their highly experienced and talented clinical development team, allowing us to accelerate the ongoing US and EU Phase 2 trial with NOUS-209. Based on our published and presented Phase 1 clinical data^1,2 we see great potential of this combination approach in addressing the unmet medical need in these patients. We look forward to presenting preliminary data in 2023.”

Under the terms of the agreement, MSD will supply KEYTRUDA. Nouscom retains all worldwide commercial rights to NOUS-209.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

References 

1. ASCO Presentation: First clinical and immunogenicity results including all subjects enrolled in a phase I study of NOUS-209, an off-the-shelf immunotherapy, with pembrolizumab, for the treatment of tumors with a deficiency in mismatch repair/microsatellite instability (dMMR), Professor Marwan G. Fakih, M.D.
2. A.M. D’Alise et al. Adenoviral Based-Vaccine Promotes Neoantigen Specific CD8+ T Cell Stemness And Tumor Rejection, Science Translational Medicine; 14, 657, 2022