Verismo plans to begin enrollment in the STAR-101 trial in the first quarter of 2023.
The FDA has cleared the investigational new drug application (IND) for SynKIR-110, Verismo Therapeutics’ killer immunoglobulin-like receptor - chimeric antigen receptor (KIR-CAR) T-cell therapy for the intended treatment of mesothelin expressing ovarian cancer, cholangiocarcinoma and mesothelioma.1
Verismo will soon initiate the first-in-human trial STAR-101 (SynKIR T cell Advanced Research) of SynKIR-110. The company plans to begin enrollment in the first quarter of 2023. The trial’s first clinical site will be the Hospital of the University of Pennsylvania. Mesothelin-expressing ovarian cancer, cholangiocarcinoma and mesothelioma are areas of high unmet medical need, with 5-year survival rates of 49.7%, 30%, and 10%, respectively.
"Pre-clinical data have shown enhanced efficacy in murine models with no additional safety concerns. The FDA's clearance of our SynKIR-110 IND represents a new chapter for Verismo as we initiate the first-ever clinical trial for KIR-CAR T cells. It also validates the years of innovative research and hard work by industry pioneers at Penn and the Verismo team," Bryan Kim, DMD, chief executive officer, Verismo, said in a statement.1
SynKIR T cells use a next generation approach to target solid tumors, supported by the KIR-CAR platform. The multi-chain KIR-CAR construct, based on natural killer (NK) cell receptors, is designed to reduce T cell exhaustion by utilizing the natural on/off switch that will allow cells to rest when not bound to the tumor. The construct is also designed to improve the performance of cells in the solid tumor microenvironment with enhanced surface stability and DAP12 costimulatory chains to aid additional T-cell stimulating pathways and further improve cell persistence.
"SynKIR-110 is the first product to use the novel KIR-CAR platform. Our technology incorporates a natural on/off switch that allows KIR-CAR T cells to rest when not exposed to tumor antigens, as well as providing an enhanced cell-surface stability of the KIR-CAR," Laura Johnson, PhD, chief scientific officer, Verismo, added to the statement.1 "These enhancements will allow KIR-CAR T cells to better cope with the harsh tumor microenvironment of solid tumors and, potentially, lead to better outcomes for our patients."
Verismo submitted the SynKIR-110 IND to the FDA in August 2022.2 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 believes the platform has the potential to 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.
"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.2 "We are thrilled to advance our treatment one step closer to helping patient populations with severely unmet medical needs."