Nouscom and MSD sign a clinical trial and supply agreement

Nouscom's proprietary viral vector platform has the capacity to encode for large payloads of neoantigens or other immunomodulators and to safely and potently harness the power of the immune system.

Nouscom is currently advancing the clinical development of its wholly owned programs, including NOUS-209 off-the-shelf immunotherapy targeting 209 specifics, shared neoantigens found in dMMR/MSI-H unresectable or metastatic gastric, colorectal and gastro-oesophagal junction tumours. MSI-H tumours are characterized by a defective DNA mismatch repair system, which generates highly immunogenic neoantigens called frameshift peptides (FSP) that are not present in healthy tissue.

NOUS-209 is being investigated in multi-centre EU and US Phase 2 randomized clinical trials. The Phase 2 study includes two cohorts in dMMR/MSI-H unresectable and metastatic CRC (NCT04041310) assessing the efficacy and safety of NOUS-209 in combination with pembrolizumab. The two cohorts are organised as follows:

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.

The company has now entered a partnership with MSD (Merck & Co., Inc., Rahway, NJ, USA) in which MSD will supply KEYTRUDA, a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Nouscom retains all worldwide commercial rights to NOUS-209.

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 data1,2, we see great potential for this combination approach in addressing the unmet medical need in these patients. We look forward to presenting preliminary data in 2023.”

(Press release/RAN)