Tetra Bio-Pharma Inc. has received clearance from Health Canada to proceed with a first-in-human trial in Canada using oral ARDS-003 (onternabez) to treat various immunomodulatory conditions. Oral ARDS-003 is positioned to modulate acute systemic inflammation and prevent sepsis, acute respiratory distress syndrome (ARDS) and organ damage.
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.
Mabwell (Shanghai) Bioscience Co. Ltd. has received approval of its IND application from Australia's Therapeutic Goods Administration (TGA) for 9MW3811 injection for tumors and pulmonary fibrosis.
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