The FDA has signed off TScan Therapeutics Inc's (NASDAQ:TCRX) investigational new drug (IND) application for TSC-100 in hematologic malignancies patients 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 1H of 2022.
- Preliminary data is expected in 2H of 2022.
- TScan plans to initiate a multi-arm Phase 1 umbrella trial designed to evaluate TSC-100 compared to standard-of-care in patients undergoing allogeneic HCT.
- The Company will then initiate the TSC-101 arm of this trial in the same patient population. Primary endpoints include safety and dose-finding.
- As of September 30, 2021, the Company held cash & cash equivalents of $182.9 million that is expected to fund its operating expenses into 2024.
- Price Action: TCRX shares are trading 6.05% lower at $4.33 during the market session on the last check Monday.
