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).
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.
NOUS-209 is an off-the-shelf cancer immunotherapy for Microsatellite Instable High (MSI-H) tumors. MSI-H tumors are characterized by a defective DNA mismatch repair system, which generates highly immunogenic neoantigens called frame shift peptides (FSP) that are not present in healthy tissue.
NOUS-209 encodes for 209 shared FSP neoantigens, selected by Nouscom’s proprietary GENESIS (GE(netic)NE(oantigen)S(election)I(n)S(ilico)) algorithm. In published prospective validation studies, approximately 50 of the 209 neoantigens are expressed in any one patient’s tumor. These FSPs are cloned into Nouscom’s heterologous prime / boost viral vector platform of a Great Ape Adenoviral (GAd) and Modified Vaccinia Ankara (MVA) and potently generate FSP neoantigen specific CD8+ T cells, which have been shown to successfully infiltrate tumor microenvironments to exert anti-tumor activity.
NOUS-209 is being investigated in multi-center EU and US Phase 2 randomized clinical trials in patients with dMMR/MSI-H unresectable and metastatic colorectal cancer (CRC) (NCT04041310) in combination with checkpoint inhibitors (CPI) versus CPI alone and in patients who have stopped responding to previous anti-PD1 and other approved CPI therapies.
Priority medicines (PRIME) is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. The scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimize development plans and speed up evaluation so these medicines can reach patients earlier EMA CHMP acknowledges that n
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