First Patient With MSLN-Solid Tumors Receives SynKIR-110 CAR T-Cell Therapy

Verismo Therapeutics has dosed the first patient with mesothelin-expressing solid tumors, including advanced ovarian cancer, mesothelioma, and cholangiocarcinoma, in its phase 1/2 STAR-101 trial (NCT05568680) of SynKIR-110 chimeric antigen receptor (CAR) T-cell therapy.¹

"This represents a significant milestone for our company and demonstrates the commitment of our team to address the critical need for additional treatment options for patients with mesothelin-expressing solid tumors," Bryan Kim, DDM, co-founder and chief executive officer, Verismo Therapeutics, said in a statement.¹ "We're proud to work with the distinguished team at Penn to take our SynKIR-110 treatment out of the lab and to the patients with unmet medical needs."

SynKIR-110 is based off of the KIR-CAR platform developed at the University of Pennsylvania. The STAR-101 trial is designed to evaluate the safety, feasibility, and potential activity of a single intravenous dose of SynKIR-110. The therapy is composed of autologous T cells transduced with a mesothelin-targeted KIR-CAR.

STAR-101 will treat up to 42 participants to complete an initial tumor biomarker screening, followed by an enrollment screening period, including pre-leukapheresis safety/eligibility and leukapheresis, and then a treatment period of non-myeloablative lymphodepleting chemotherapy followed by a single infusion of SynKIR-110 to be followed up for a 12-month follow-up period or until disease progression. Participants will be invited to a long-term safety follow-up study at the end of follow-up.

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The trial will have up to 6 cohorts of 3 to 6 subjects per cohort. Doses will be escalated following a standard 3 + 3 design until a maximum tolerated or feasible dose is reached, at which point an additional 6 to 9 subjects will be enrolled at that dose level. The trial initiated in May 2023 and SynKIR-110 has previously received fast track designation from the FDA.^2,3

"We are excited to initiate this Phase 1 clinical trial of SynKIR-110, which, based on preclinical testing in relevant animal models, holds promise as a potential new therapeutic for patients with advanced ovarian cancer, cholangiocarcinoma, and mesothelioma," principal investigator Janos L. Tanyi, MD, PhD, associate professor, Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, added.¹ "By leveraging the power of autologous T cells transduced with Mesothelin KIR-CAR, we hope to enhance treatment options and ultimately improve outcomes for patients facing these challenging malignancies."

REFERENCES

1. Verismo Therapeutics doses first patient in groundbreaking SynKIR-110 clinical trial for advanced cancers. News release. Verismo Therapeutics. September 6, 2023. https://www.prnewswire.com/news-releases/verismo-therapeutics-doses-first-patient-in-groundbreaking-synkir-110-clinical-trial-for-advanced-cancers-301918684.html?tc=eml_cleartime/
2. Verismo Therapeutics announces the activation of its STAR-101 clinical trial at the University of Pennsylvania. News release. Verismo Therapeutics. May 2, 2023. https://www.prnewswire.com/news-releases/verismo-therapeutics-announces-the-activation-of-its-star-101-clinical-trial-at-the-university-of-pennsylvania-301812763.html?tc=eml_cleartime
3. Verismo Therapeutics secures fast track designation from the U.S. Food and drug administration (FDA) for SynKIR-110. News release. Verismo Therapeutics. April 5, 2023. Accessed April 10, 2023. https://www.prnewswire.com/news-releases/verismo-therapeutics-secures-fast-track-designation-from-the-us-food-and-drug-administration-fda-for-synkir-110-301789884.html