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TScan Therapeutics Announces FDA Clearance of Investigational New Drug Application for TSC-101 for the Treatment of Hematologic Malignancies
Study start-up activities now ongoing for all three arms of the Phase 1 umbrella trial of TSC-100 and TSC-101 WALTHAM, Mass., May 31, 2022 (GLOBE NEWSWIRE) --
About this update from Tscan Therapeutics, Inc.
[{"type":"text","content":"Study start-up activities now ongoing for all three arms of the Phase 1 umbrella trial of TSC-100 and TSC-101\nWALTHAM, Mass., May 31, 2022 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage 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-101 for the treatment of patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation (HCT). The target of TSC-101 is the minor histocompatibility antigen HA-2, which is a lineage-specific antigen expressed on blood cells. TScan believes that TSC-101 is the first clinical program to target the HA-2 antigen. As previously announced, TScan’s IND for TSC-100, which targets the minor histocompatibility antigen HA-1, was cleared by the FDA in January 2022. TSC-100 and TSC-101 are designed to address different subsets of patients undergoing allogeneic HCT. Study start-up activities are now ongoing for all three arms of TScan’s umbrella Phase 1 clinical trial, which includes active treatment arms for TSC-100, TSC-101, as well as a control arm using current standard-of-care for HCT patients. TScan expects to enroll the first patient in the middle of the year. “This marks TScan’s second IND clearance in our leukemia program. Our TCRs against both HA-1 and HA-2 antigens are aimed at reducing the risk of relapse following HCT, thereby enabling increased use of more tolerable conditioning regimens to allow more leukemia patients to be cured by transplantation,” said David Southwell, President and Chief Executive Officer. “With the FDA clearance of TSC-101, we will now proceed with all components of our planned multi-arm Phase 1 clinical trial, with preliminary data from all three arms of the trial expected by the end of 2022.” “We look forward to fully opening the Phase 1 umbrella trial for our leukemia program,” said Gavin MacBeath, Chief Scientific Officer. “The trial will include patients positive for either the HA-1 or HA-2 antigens, with remaining patients receiving standard-of-care in the control arm. Importantly, the INDs for TSC-100 and TSC-101 were based on our proprietary T-Integrate...