SynKIR-110 was also granted fast track designation by the FDA in April 2023.
Verismo Therapeutics has activated the phase 1 STAR-101 clinical trial (NCT05568680) of SynKIR-110 in patients with mesothelin (MSLN)-expressing pleural mesothelioma, cholangiocarcinoma, or ovarian cancer at the University of Pennsylvania.1
"This trial marks a pivotal moment for our company," Bryan Kim, DMD,cofounder and chief executive officer, Verismo Therapeutics, said in a statement.1 “We are grateful for the opportunity to partner with distinguished researchers at the University of Pennsylvania, including Dr. Janos Tanyi, MD, PhD, Dr. Andrew Haas, MD, PhD, and Dr. Mark O'Hara, MD, to bring this innovative therapy to those who require it the most."
SynKir-110 is developed with the use of Verismo’s KIR-CAR platform and combines an MSLN-specific antibody with natural killer cell signals to target MSLN-expressing tumors. The KIR-CAR platform isa dual-chain chimeric antigen receptor (CAR) T-cell platform. The therapy has demonstrated its ability to maintain antitumor T-cell activity within the tumor microenvironment. The platform also uses DAP12, which acts as a novel costimulatory molecule for T-cells to further improve expression and persistence.Verismo is also investigating the use of the KIR-CAR platform in combination with in vivo gene engineering, cell reprogramming, allogeneic therapies, and other techniques.
"Our team is excited to be part of this clinical trial with Verismo. We are enthusiastic about the prospects of this innovative therapy and its capacity to provide new hope and improved outcomes for individuals who urgently need effective treatment options,” Tanyi, an associate professor of Obstetrics and Gynecology in the Perelman School of Medicine at the University of Pennsylvania, and a principal investigator, added to the statement.1
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Verismo previously presented an overview of the STAR-101 trial at the Annual Cholangiocarcinoma Foundation Conference in Salt Lake City, Utah, during April 12-14.2 The trial will assess safety, feasibility, preliminary efficacy, biomarkers, and a recommended phase 2 dose of SynKIR-110. Presented data included promising preclinical safety and efficacy data.Enrolled patients must be receiving standard-of-care therapy, have at least 1 measurable, MSLN-expressing lesion with progressive/inoperative disease, and good performance status.
"We are committed to finding new treatments for this devastating disease and we look forward to sharing our progress,” Laura Johnson, PhD, chief scientific officer, Verismo Therapeutics, said in a statement at that time.2
The FDA previously granted fast track designation to SynKIR-1101 in April 2023 for treating MSLN-expressing cancers after clearing its investigational new drug application and granting orphan drug designation to the therapy in September 2022.3,4,5
"We are thrilled to receive fast track designation from the FDA," Kim said in an earlier statement.3 "This designation is an important milestone in our efforts to bring this potentially life-saving drug to patients who are in need of new treatment options."