Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized immunotherapies, says the first patient has been dosed in a randomized phase 2 clinical trial evaluating NOUS-209 in combination with anti-PD1 checkpoint inhibitor (CPI) pembrolizumab versus pembrolizumab alone.
NOUS-209 is an off-the-shelf immunotherapy targeting 209 specific neoantigens for the treatment of mismatch repair/microsatellite instable high (dMMR/MSI-H) unresectable or metastatic gastric, colorectal and gastro-esophageal junction tumors.
Nouscom is assessing the efficacy and safety of NOUS-209 in combination with pembrolizumab at multiple sites across Europe and the U.S. The phase 2 study will include two cohorts in dMMR/MSI-H unresectable and metastatic colorectal cancer (CRC).
These are a randomized cohort enrolling patients who are eligible for first line treatment of NOUS-209 plus pembrolizumab versus pembrolizumab alone; and a single arm cohort enrolling patients who have stopped responding to previous anti-PD1 and other approved therapies.
Hope for better treatment
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, said: “The continued clinical development of NOUS-209 is critical as there remains a significant unmet need in the treatment of CRC, including overcoming tumor resistance to anti-PD1 immunotherapies. Data from the phase 1 study presented at ASCO 2022 and published in Science Translational Medicine demonstrated how NOUS-209 induces neoantigen specific CD8+ T cells which infiltrate metastatic tumors and exert anti-tumor efficacy, providing hope for better treatment options for this patient population with difficult to treat cancers.”
Marina Udier, chief executive officer of Nouscom, said: “The initiation of the phase 2 study is another significant milestone this year for our company. Building on our published safety, immunogenicity and mechanism of action clinical data, the trial, together with the phase 1 ‘cancer interception’ monotherapy study in Lynch Syndrome carriers, will allow us to demonstrate the efficacy of NOUS-209 and illustrate the power of our platform. We look forward to presenting interim results at key conferences during 2023.”
About Nouscom’s 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.
Nouscom’s NOUS-209 is being investigated in multi-center EU and U.S. 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.