{"id":903956,"date":"2025-11-03T07:32:22","date_gmt":"2025-11-03T12:32:22","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/tscan-therapeutics-reaches-agreement-with-fda-on-pivotal-study-design-for-tsc-101-and-announces-strategic-prioritization-to-advance-tsc-101-and-extend-cash-runway-into-h2-2027\/"},"modified":"2025-11-03T07:32:22","modified_gmt":"2025-11-03T12:32:22","slug":"tscan-therapeutics-reaches-agreement-with-fda-on-pivotal-study-design-for-tsc-101-and-announces-strategic-prioritization-to-advance-tsc-101-and-extend-cash-runway-into-h2-2027","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/tscan-therapeutics-reaches-agreement-with-fda-on-pivotal-study-design-for-tsc-101-and-announces-strategic-prioritization-to-advance-tsc-101-and-extend-cash-runway-into-h2-2027\/","title":{"rendered":"TScan Therapeutics Reaches Agreement with FDA on Pivotal Study Design for TSC-101 and Announces Strategic Prioritization to Advance TSC-101 and Extend Cash Runway into H2 2027"},"content":{"rendered":"
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\n Positive end of Phase I meeting and agreement reached with FDA on pivotal study design for TSC-101<\/em>\n <\/p>\n

\n Dosed first solid tumor patients with multiplex TCR-T therapy; paused further enrollment to prioritize heme development; reiterates planned data readout in Q1 2026<\/em>\n <\/p>\n

\n Enacted ~30% workforce reduction to focus clinical development on heme program and initiate pre-clinical development of in vivo-engineered TCR-T for solid tumors<\/em>\n <\/p>\n

\n Strategic prioritization extends cash runway into H2 2027<\/em>\n <\/p>\n

\n Conference call and webcast scheduled for Monday, November 3, 8:00 a.m. Eastern Time<\/em>\n <\/p>\n

WALTHAM, Mass., Nov. 03, 2025 (GLOBE NEWSWIRE) — TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced regulatory and clinical program updates, implementation of a workforce reduction of approximately 30%, and extension of its cash runway into the second half of 2027.<\/p>\n

Following a productive End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA), the Company has reached alignment on the registrational path forward for the TSC-101 program as a treatment for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The pivotal study will mirror TScan\u2019s ongoing Phase 1 study, using a biologically assigned internal control arm to support relapse-free survival as the primary endpoint. Through a strategic prioritization, the Company will advance clinical development of its heme program, pause further enrollment in its solid tumor Phase 1 trial, and focus preclinical efforts on developing in vivo-engineered TCR-Ts for solid tumors and on target discovery for autoimmunity. In connection with this strategy, the Company\u2019s workforce is being reduced by approximately 30%, or 66 employees.<\/p>\n

\u201cWe 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,\u201d said Gavin MacBeath, Ph.D., Chief Executive Officer. \u201cIn 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.\u201d<\/p>\n

Dr. MacBeath continued, \u201cWe have a unique opportunity to develop and potentially commercialize a compelling program for patients with heme malignancies and are well positioned to develop the first in vivo-engineered TCR-T program for patients with solid tumors. This prioritization best enables TSC-101 to be developed as quickly and efficiently as possible. Unfortunately, these strategic measures impact a number of our talented TScanners. I am deeply grateful for their commitment to TScan\u2019s mission and their dedication to the patients with serious diseases that we aim to treat and ultimately cure.\u201d<\/p>\n

\u201cBy focusing clinical development on heme and rightsizing the organization accordingly across all functions, we expect to realize annual cost savings of approximately $45.0 million in 2026 and 2027,\u201d said Jason A. Amello, Chief Financial Officer. \u201cThis achieves our goal of preserving capital while continuing to build shareholder value. As a result of these efforts, we have extended our cash runway into the second half of 2027.\u201d<\/p>\n

\n Corporate Updates<\/strong>\n <\/p>\n

\n Hematologic Malignancies Program<\/em>\n <\/p>\n