Eloxx Pharmaceuticals Inc. has filed an IND application with the FDA for ZKN-013 for the...

Molecular Templates Inc. has received IND clearance from the FDA for its novel MT-8421 engineered toxin bodies (ETB) program targeting cytotoxic T-lymphocyte protein 4 (CTLA-4) in patients with relapsed/refractory solid tumors previously exposed to checkpoint inhibitors. MT-8421 is designed to eliminate CTLA-4-expressing regulatory T cells (Tregs) in the tumor microenvironment (TME) through a direct cell-kill mechanism independent of the effector cell presence that antibodies rely upon while not affecting Tregs in the periphery.

Estrella Biopharma Inc. has received FDA clearance of its IND application for lead product candidate EB-103, a T-cell therapy targeting CD19, a protein expressed on the surface of almost all B-cell leukemias and lymphomas.

Bioatla Inc. has received FDA clearance of its IND application to evaluate BA-3182, a conditionally active biologic (CAB) EpCAM/CD3 bispecific T-cell engager antibody, for the treatment of advanced adenocarcinoma. The company plans to initiate a phase I study this year.