Patients Needed for New Mesothelioma Clinical Trial
A new investigational drug for mesothelioma can now begin human trials after it was granted fast-track designation by the U.S. Food and Drug Administration last week. The novel treatment, SnyKIR-110, is a T-cell therapy designed to treat patients with mesothelioma, cholangiocarcinoma (bile duct cancer) and ovarian cancer.
“We are thrilled to receive fast-track designation from the FDA,” said Dr. Bryan Kim, co-founder and CEO of Verismo Therapeutics. “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.”
Fast-track designation is a process that helps develop and review new drugs that treat serious conditions and fill an unmet medical need. The main purpose is to get new drugs to the patient sooner, according to the FDA.
Recruitment for Human Trials Underway
Verismo Therapeutics is now recruiting patients to be part of the trial at the University of Pennsylvania in Philadelphia. The phase 1 clinical trial will be conducted with patients who have specific cancerous tumors. It will evaluate the drug’s safety and effectiveness and determine the best dosage.
Verismo plans to enroll as many as 42 adult patients with confirmed recurrent or relapsed advanced ovarian cancer, primary peritoneal cancer, fallopian tube cancer, cholangiocarcinoma, or epithelial mesothelioma. Patients must have completed at least one prior line of systemic therapy for advanced disease.
Trial patients also must have an Eastern Cooperative Oncology Group performance status of 0 to 1, at least one measurable lesion, and have satisfactory blood coagulation parameters as well as organ and bone marrow function.
Long-Term Safety Study to Follow
The study, which has not yet begun, will start with a tumor biomarker screening followed by an enrollment screening period and then a treatment period. Patients will be followed for 12 months or until disease progression. At that point, they will be eligible to participate in a long-term safety follow-up study.
During the trial, patients will be intravenously given SynKIR-110 as a single dose gravity drip. Investigators will use a dose-escalation method and follow a standard 3 + 3 design until the maximum tolerated dose, or MTD, is reached. Afterward, six to nine patients will be enrolled in the MTD trial to continue to evaluate the safety and potential impact of SynKIR-110.
The study is estimated to be completed by March 2026.
T-Cell Therapy Used to Treat Mesothelioma
Verismo Therapeutics, a biotech research company, is headquartered in Philadelphia. It works to develop novel “chimeric antigen receptors (CARs) that enhance T-cell-based cellular immunotherapy for cancer, especially non-hematologic malignancies with few effective therapeutic options,” according to the company.
T cells are part of the immune system and develop from stem cells in the bone marrow. They help protect the body from infection and may help fight cancer.
“Verismo Therapeutics’ core technology is built upon CARs that are uniquely engineered to more realistically reflect the natural multichain design of killer immunoglobulin-like receptors (KIRs), an important family of immunologic receptors used by T cells and NK cells,” the company states. NK cells are a type of white blood cell.
Most drugs have to pass through multiple phases before getting FDA approval. As of January 2022, there were more than 115 clinical research trials actively recruiting mesothelioma patients.