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

Loading...
Loading...

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.
Posted In: BiotechNewsPenny StocksHealth CareFDAMoversTrading IdeasGeneralBriefsPhase 1 Trial
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...