If approved, the company will initiate the first-in-human STAR-101 phase 1 clinical trial.
Verismo has submitted an investigational new drug application (IND) to initiate a first-in-human phase 1 clinical trial, dubbed STAR-101, to assess SynKIR-110 in patients with mesothelin-expressing ovarian cancer, mesothelioma and cholangiocarcinoma.1
SynKIR-110 is a T-cell therapy developed with Verismo’s KIR-CAR platform technology, a dual-chain chimeric antigen receptor (CAR) T cell therapy platform based on natural killer (NK) cell receptors. The platform naturally stimulates T cells to turn on and off without triggering T cell exhaustion. It also uses DAP12 costimulatory chains to aid additional T-cell stimulating pathways and further improve cell persistence.
"Initiation of the STAR-101 clinical trial based on the KIR-CAR platform technology is a momentous company milestone that represents years of research from industry pioneers and the tremendous focus and commitments of the Verismo team," Bryan Kim, DMD, chief executive officer, Verismo, said in a statement.1 "We are thrilled to advance our treatment one step closer to helping patient populations with severely unmet medical needs."
The KIR-CAR platform has demonstrated ongoing regression of solid tumors in preclinical studies, including in models refractory to traditional CAR T-cell therapies. Verismo also believes that the platform can be combined with other emerging techniques including in vivo gene editing, allogeneic cell therapies, advanced T cell selection, and combination therapies to further improve options and outcomes for patients.
Additional KIR-CAR T-cell programs are currently in preclinical studies at the University of Pennsylvania (UPenn), where Verismo is a spin-out from. The company announced an additional research partnership with UPenn to fund these preclinical programs in June 2022.2 The research will be funded until 2025 in the laboratories of Michael C. Milone, MD, PhD, an associate professor of Pathology and Laboratory Medicine, and Donald L. Siegel, MD, PhD, a professor of Pathology and Laboratory Medicine.
Milone, along with Dr. Carl June, is the lead inventor of the KIR-CAR technology, and Siegel is an expert in phage display technology. Under the Sponsored Research Agreement, Milone’s lab will continue IND-enabling studies for other KIR-CAR programs and Siegel’s lab will use the platform to generate novel cancer target antibodies.
"Our ongoing collaboration with Penn brings us closer to our goal to treat solid tumors. Dr. Milone and Dr. Siegel have a clear vision of what scientific advances are needed to advance our progress and pipelines. I am hopeful that the collaboration between Penn and Verismo will accelerate the development of the KIR-CAR therapy and ultimately bring a new much needed treatment option to patients with solid tumors," Kim said in a previous statement.2