The U.S. Food and Drug Administration (FDA) issued a fast track designation to a CAR T-cell therapy for malignant mesothelioma.
The FDA granted this designation to the CAR T-cell therapy SynKIR-110. This treatment helps a mesothelioma patient’s T-cells more effectively target mesothelioma cells. SynKIR-110 programs the T-cells to look for the protein mesothelin, which is often expressed on the surface of mesothelioma cells.
SynKIR-110 is developed by Verismo Therapeutics, which is a biopharmaceutical spinout from Penn Medicine at the University of Pennsylvania. Penn Medicine’s Abramson Cancer Center is one of the top mesothelioma cancer centers.
What the FDA Fast Track Designation Means
FDA’s fast track designation is a major step forward. This allows for faster review and approval of therapies, especially for rare and aggressive cancers like mesothelioma.
This news is the second involving SynKIR-110 for mesothelioma. Last year, the FDA gave the CAR T-cell therapy Orphan Drug Designation. This designation can help advance the CAR T-cell therapy and test it in patients with malignant mesothelioma.
Orphan Drug Designation is awarded to new therapies for rare diseases, such as mesothelioma. The designation provides funding assistance to biopharmaceutical companies and medical institutions to inspire them to prioritize research and therapeutic development for rare diseases.
Other therapies – such as the oncolytic virus therapy ONCOS-102 – have received fast track designation for mesothelioma. The hope is they lead to quicker approval and more treatment options for people with this cancer.
What Is CAR T-cell Therapy?
CAR T-cell therapy is a type of immunotherapy where T cells are engineered to better look for cancer cells. CAR stands for “chimeric antigen receptor.” A chimeric antigen receptor is a new protein receptor added to T cells to give the cells a new set of instructions for how to protect the body from diseases such as cancer.
Doctors remove the patient’s T cells and add the chimeric antigen receptor in a laboratory. The CAR T cells are then duplicated and returned to the patient’s bloodstream to fight cancer.
This type of immunotherapy is called cell and gene therapy. There are a handful of CAR T-cell therapies approved by the FDA for blood cancers such as lymphoma and leukemia, but none yet are approved for solid tumors such as lung cancer, pancreatic cancer or mesothelioma.
SynKIR-110 will be featured in a phase 1 clinical trial for patients with mesothelin-expressing mesothelioma, cholangiocarcinoma and ovarian cancer. The trial is expected to enroll patients starting in the first half of 2023. It’s a first-in-human clinical trial of the CAR T-cell therapy, which uses a dual-chain platform to target mesothelin and DAP12 to improve T-cell stimulation.
- FDA Grants Fast Track Designation to Novel T-Cell Therapy in Mesothelioma. Cancer Network. Retrieved from: https://www.cancernetwork.com/view/fda-grants-fast-track-designation-to-novel-t-cell-therapy-in-mesothelioma. Accessed: 04/12/2023.
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