Moonlight Therapeutics Inc.’s IND application for MOON-101 has been cleared by the FDA, paving the way for a first clinical trial in adults and children with peanut allergy.
Tr1x Inc. has obtained IND clearance from the FDA for TRX-319, paving the way for initiation of a phase I/IIa study in progressive multiple sclerosis (MS) early next year. TRX-319 is designed to combine targeted B-cell control with active anti-inflammatory signaling and T-cell regulation, with the goal of restoring immune balance.
Corventum Inc. has gained IND clearance from the FDA for CVT-130 for the prevention of anthracycline-related cardiotoxicity. In cancer patients, the use of anthracyclines as chemotherapy is effective but limited by cumulative heart damage. Protecting against this chemotherapy-induced cardiac injury could enable retreatment for patients with recurrent cancer.
Hinge Bio Inc. has obtained IND approval from the FDA to initiate a phase I study of HB-2198 in patients with the B cell-mediated autoimmune diseases systemic lupus erythematosus (SLE) and lupus nephritis. The trial is expected to open this quarter.
Revir Therapeutics Inc.’s RTX-117 has been awarded orphan drug designation by the FDA for Charcot-Marie-Tooth disease. RTX-117 is a small-molecule therapy designed to activate eIF2B to restore translation of cap-dependent mRNAs to normalize protein expression.
Sichuan Biokin Pharmaceutical Co. Ltd. has gained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with [177Lu]-BL-ARC001 injection.
Allterum Therapeutics Inc. has obtained IND clearance from the FDA for 4A10, paving the way for initiation of a first-in-human phase I trial in patients with relapsed or refractory acute lymphoblastic leukemia (ALL). 4A10 is a monoclonal antibody with a human immunoglobulin G subclass 1 (IgG1) backbone that specifically binds to CD127 (IL-7Rα).
Bryet US Inc. has received Australian Human Research Ethics Committee (HREC) approval for its first-in-human study of ML-016 for patients with advanced cancer with lung and/or liver involvement. Enrollment in the phase I/II trial will begin early next year.
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