On May 31, 2022 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, reported 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) (Press release, TScan Therapeutics, MAY 31, 2022, View Source [SID1234615269]). 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 cell engineering platform, which includes our advanced non-viral vector and our in-house GMP manufacturing capabilities. We will use this same platform to develop enhanced TCR-T cell therapies for our solid tumor program, with IND filings beginning later this year."

Primary endpoints in TScan’s HCT trial include safety and dose-finding, and secondary and exploratory endpoints include relapse rate versus standard-of-care as well as quantitative biological readouts including minimal residual disease and kinetics of donor chimerism.