Qyuns Therapeutics Co. Ltd. signed a potential $1.07 billion license deal with Roche Holding AG, granting the latter exclusive rights to QX-031N – a human thymic stromal lymphopoietin and interleukin-33)-targeting bispecific antibody.
Dewpoint Therapeutics Inc. has announced an IND in the U.S. for DPTX-3186, a first-in-class oral condensate modulator designed to selectively disrupt oncogenic Wnt/β-catenin signaling in tumors. Dosing is set to begin before year-end in a phase I/II trial conducted in partnership with cancer centers and opinion leaders in gastric and other Wnt-driven cancers.
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.
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).
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.
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