FDA Gives Nod To TScan Therapeutics' Early-Stage Trial Of TSC-100 In Hematologic Malignancies

The FDA has signed off TScan Therapeutics Inc's 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.