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.

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).

Complement Therapeutics GmbH has obtained clearance for CTx-001, a gene therapy candidate.

The FDA has cleared AD-NP1, a drug developed by University of California, Los Angeles (UCLA) for heart tissue regeneration, to enter clinical trials. The monoclonal antibody blocks the production of ENPP1 protein, which was found to interfere with healing after a heart attack.

Simcere Zaiming Pharmaceutical Co. Ltd. has obtained IND clearance by the FDA for SIM-0609, a CDH17-targeting antibody-drug conjugate (ADC) for the treatment of advanced solid tumors. An IND was also approved in China earlier this month.

Rakuten Medical Inc. is advancing a pipeline of solid tumor therapeutics built on its Alluminox platform worldwide, having gained conditional early approval of ASP-1929, an Alluminox-derived photoimmunotherapy, in Japan in 2020.

The FDA has cleared HDT Bio Corp.’s IND application for HDT-321, a first-in-class prophylactic designed to protect against Crimean-Congo hemorrhagic fever (CCHF).