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TScan Therapeutics Announces FDA Clearance of Investigational New Drug Application for TSC-100 for the Treatment of Hematologic Malignancies
– Phase 1 trial of TSC-100 expected to initiate in the first half of 2022 – – IND for TSC-101 on hold pending additional assessment of the risk of off-tumor
About this update from Tscan Therapeutics, Inc.
[{"type":"text","content":"– Phase 1 trial of TSC-100 expected to initiate in the first half of 2022 – – IND for TSC-101 on hold pending additional assessment of the risk of off-tumor reactivity – WALTHAM, Mass., Jan. 24, 2022 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate TSC-100 for the treatment of patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation (HCT). The target of TSC-100 is the minor histocompatibility antigen HA-1, which is a lineage-specific antigen found on blood cells. The Company will now submit the clinical protocol to Institutional Review Boards (IRB) for the initial study sites and expects to begin dosing patients in the first half of 2022. TSC-101 is targeted to the lineage-specific blood cell antigen HA-2, which is a novel target for cell therapy. The Company received a brief communication from the FDA indicating that the TSC-101 IND has been placed on hold pending additional assessment of the risk of off-tumor reactivity for TSC-101. The Company expects to receive further written communication from the FDA in the near future and plans to work with the agency to resolve its questions as quickly as possible. “FDA clearance of our IND application for TSC-100 is an important milestone for our lead liquid tumor program as it marks the first clinical-stage product candidate to advance from our pipeline of therapies geared to treat unmet needs in major cancer indications,” said David Southwell, President and Chief Executive Officer. “We are excited about the potential of both TSC-100 and TSC-101 to prevent relapse in leukemia patients following HCT. We are looking forward to initiating our Phase 1 multi-arm clinical trial in the first half of this year, with preliminary data expected in the second half of 2022. We will be opening the TSC-101 arm upon FDA clearance of the TSC-101 IND.” “FDA clearance of our TSC-100 IND is significant as it allows us to move forward with the umbrella clinical protocol for our hematologic cancer study,” said Gavin MacBeath, Chief Scientific Officer. “This i...