FDA Green Lights Fast Track Designation of SynKIR-110 for Mesothelioma

The investigational new drug, SynKIR-110, has received a fast track designation from the FDA for patients with mesothelioma and is continuing to be evaluated in a phase 1 trial.

The FDA has granted a fast track designation to the investigational new drug, SynKIR-110, for the treatment of patients with mesothelioma, according to Verismo Therapeutics.1

SynKIR-110 is an investigational new drug being developed for the treatment of patients with mesothelin-expressing mesothelioma, cholangiocarcinoma, and ovarian cancer.

Currently, investigators are evaluating SynKIR-110 in a phase 1 multicenter, first-in-human, clinical trial (NCT05568680) for patients with these tumor types. The goals of the trial are to evaluate the safety, feasibility, and anti-tumor activity of SynKIR-110 for these patient populations.2

The trial plans to enroll up to 42 patients aged 18 years or older with pathologically confirmed recurrent or relapsed advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or epithelial mesothelioma after at least 1 prior line of systemic therapy for advanced disease. Patients must have an ECOG performance status of 0 or 1, at least 1 measurable lesion, satisfactory blood coagulation parameters, and satisfactory organ and bone marrow function.

In the trial, patients will be administered SynKIR-110 as a single dose gravity drip via intravenous administration. The study consists of initial tumor biomarker screening, followed by an enrollment screening period, and a treatment period. Additionally, patients will be followed for 12 months or until disease progression, at which point they are eligible to participate in a long-term safety follow-up study.

There will be up to 6 cohorts consisting of 3 to 6 patients per cohort to assess the safety and feasibility of SynKIR-110 in this patient population. Investigators will use a dose-escalation method and follow a standard 3 + 3 design until the maximum tolerated dose (MTD)is reached. Then, another 6 to 9 patients will be enrolled at the MTD so investigators can continue to evaluate the safety and potential activity of SynKIR-110.

The primary end point of the study is to assess the safety and feasibility of SynKIR-110 and the secondary end point aims to determine the MTD of the agent.

The study is not yet recruiting patients and has an estimated study completion date of March 30, 2026.

"We are thrilled to receive Fast Track designation from the FDA," said Bryan Kim, MD, DMD, co-founder and chief executive officer of Verismo Therapeutics, in a press release. "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."

1. 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 5, 2023. https://prn.to/3UjcFij
2. SynKIR-110 for mesothelin expressing ovarian cancer, cholangiocarcinoma, and ovarian cancer. ClinicalTrials.gov. Updated October 6, 2022. Accessed April 5, 2023. https://clinicaltrials.gov/ct2/show/NCT05568680
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