2023-03-09 10:44:51 ET
- Molecular Templates ( NASDAQ: MTEM ) added ~9% in the morning hours Thursday after announcing that the FDA has greenlighted its Investigational New Drug Application for MT-8421, an anti-tumor candidate targeted at CTLA-4-expressing Regulatory T (Treg) cells.
- MT-8421 is designed to employ a direct cell-kill mechanism to remove CTLA-4-expressing Tregs in the tumor microenvironment without any impact on effector cells that are important for antibody response.
- The company plans to study MT-8421 in patients with relapsed/refractory solid tumors who have previously received checkpoint inhibitors. The Phase 1 trial is expected to start by mid-2023 at an initial dose of 32 mcg/kg.
- Molecular Templates ( MTEM ) said preclinical data has indicated that MT-8421 was well tolerated and performed as expected in a mouse model.
- Read: Truist warned in June 2022 that Molecular Templates ( MTEM ) had less than 12 months of cash.
For further details see:
Molecular Templates wins FDA nod to study Tregs-targeting tumor candidate