Agreement Reached with FDA on Pivotal Study Design for TSC-101 in AML & MDS
“We are encouraged by the positive feedback from the FDA on our heme program and our pivotal trial design for TSC-101. In preparation for the pivotal study, we developed a commercial-ready manufacturing process that shortens the manufacturing time by five days. This results in substantially lower cost of goods and reduces the need for high levels of ex vivo T cell expansion that we believe may be associated with decreased T cell activity in patients. The strength of our long-term data, together with our improved commercial-ready manufacturing process, validates our decision to focus resources on the heme program,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “In our solid tumor program, we have successfully dosed our first two patients with multiplex TCR-T and plan to share data in the first quarter of 2026. With our new strategic focus on clinical execution within the heme program, we are pausing further enrollment in the PLEXI-T trial and shifting efforts to the preclinical development of an in vivo engineering platform for solid tumors.”
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