Verismo Therapeutics has submitted an Investigational New Drug application to the US Food and Drug Administration (FDA) to test its experimental treatment SynKIR-110 in patients with cholangiocarcinoma, among other diseases, in a first-in-human phase 1 clinical trial called STAR-101.
If approved by the FDA, the trial will start in the first quarter of 2023, marking the first-in-human study of the KIR-CAR platform technology, which is the first naturally inducible multichain chimeric antigen receptor (CAR) T-cell therapy.
Preclinical studies have shown that the KIR-CAR platform technology is able to maintain antitumor T-cell activity, even in solid tumors that do not respond to traditional CAR T-cell therapies, leading to ongoing tumor regression. The platform provides a natural on-and-off stimulation to the T-cells, therefore avoiding T-cell exhaustion.
Cholangiocarcinoma is a heterogeneous group of rare malignant tumors originating from the cells of the biliary tree. There are 3 types of cholangiocarcinoma depending on their anatomical origin: intrahepatic, perihilar, and distal.
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The treatment options for the disease are limited to surgery plus adjuvant therapies like targeted radiation therapy. However, almost half of patients are diagnosed too late for surgery, so new and more effective treatments are urgently needed.
The advantage of the KIR-CAR platform is that it can be combined with other approaches such as in vivo gene editing, advanced T-cell selection, combination therapies, and allogeneic cellular therapies.
Verismo Therapeutics announces submission of IND application to the FDA for SynKIR-110, a KIR-CAR T-cell immunotherapy candidate. News release. Verismo Therapeutics; August 19, 2022.