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.
Incyclix Bio LLC has received FDA approval of an IND application for INX-315, a novel, potent and selective cyclin-dependent kinase 2 (CDK2) inhibitor for advanced or metastatic cancers. The first-in-human phase I/II study will be conducted in patients with estrogen receptor (ER)-positive/HER2-negative breast cancer who have progressed on a CDK4/6 inhibitor regimen and CCNE1-amplified solid tumors that have progressed on standard-of-care treatment.
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.
Insilico Medicine Inc. has received IND clearance from China's National Medical Products Administration (NMPA) for ISM-3312, an orally available 3CLpro inhibitor for the treatment of COVID-19. ISM-3312 has a novel molecular structure and was optimized from compounds designed by Chemistry42, Insilico’s generative chemistry AI platform.
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