On May 2, 2023 Verismo Therapeutics, a clinical-stage CAR-T company and University of Pennsylvania spinout developing novel KIR-CAR platform technology, reported that it has activated its STAR-101 Phase 1 clinical trial at the University of Pennsylvania (Press release, Verismo Therapeutics, MAY 2, 2023, View Source [SID1234630870]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
STAR-101 will evaluate Verismo’s lead candidate, SynKIR-110, an investigational new drug for the treatment of mesothelin-overexpressing malignant pleural mesothelioma, cholangiocarcinoma and ovarian cancer. Verismo Therapeutics is conducting a Phase 1 multicenter clinical trial in these tumor types to evaluate the feasibility and safety of SynKIR-110 (ClinicalTrials.gov Identifier: NCT05568680).
Verismo achieved clearance from the FDA to administer this multicenter clinical trial under the IND Verismo submitted for SynKIR-110, and Orphan Drug Designation for the treatment of mesothelin-expressing mesotheliomas with SynKIR-110 in September 2022. SynKIR -110 received Fast Track designation in April 2023.
"This trial marks a pivotal moment for our company," said Dr. Bryan Kim, Co-Founder and CEO of Verismo Therapeutics. 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."
Dr. Tanyi, an associate professor of Obstetrics and Gynecology in the Perelman School of Medicine at the University of Pennsylvania, and a principal investigator for the trial, said, "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."
For more information about the STAR-101 clinical trial, please visit ClinicalTrials.gov NCT05568680.
About the KIR-CAR Platform
The KIR-CAR platform is a dual-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging solid tumor environments. DAP12 acts as a novel costimulatory molecule for T cells using additional T cell stimulating pathways, further sustaining chimeric receptor expression and improving KIR-CAR T cell functional persistence. This continued T cell function and persistence can lead to ongoing regression of solid tumors in preclinical models, including those resistant to traditional CAR T cell therapies. The KIR-CAR platform is being investigated in combination with many additional emerging technologies, such as in vivo gene engineering, advanced cell manufacturing and reprogramming, combinational therapies, and even allogeneic cellular therapies to potentially provide the next-generation multimodal targeted immunotherapy for patients in need.