Medipal Holdings Corp. and JCR Pharmaceuticals Co. Ltd. have announced the completion of the clinical trial notification review by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for a phase I/II study of JR-446 for the treatment of mucopolysaccharidosis type IIIB (MPS IIIB; Sanfilippo syndrome type B).
Signet Therapeutics Inc. has received IND clearance from the FDA for SIGX-1094 as a potential treatment for diffuse gastric cancer. A phase I trial is planned in patients with diffuse gastric cancer and other advanced solid tumors.
Kbio Inc. has obtained IND clearance from the FDA for EV68-228-N, a human monoclonal IgG1 against the capsid of enterovirus D68 (EV-D68) designed as an intravenous therapeutic for the treatment of acute flaccid myelitis.
Circle Pharma Inc. has submitted an IND application to the FDA for CID-078, a first-in-class cyclin A/B RxL inhibitor. Pending approval, the company plans to initiate a phase I trial in patients with advanced solid tumor malignancies.
SCG Cell Therapy Pte Ltd. has gained FDA clearance of its IND application to initiate a phase I/II trial of SCG-142, a novel next-generation human papillomavirus (HPV) E7-specific T-cell receptor-engineered T (TCR T)-cell therapy for patients with HPV-associated solid tumors.
Concerto Bioscience Inc. has received FDA clearance of its IND application to initiate a first-in-human phase I trial of Ensemble No.2 (ENS-002), an investigational live biotherapeutic product to treat atopic dermatitis.
Monte Rosa Therapeutics Inc. has submitted an IND application to the FDA for MRT-6160, a highly selective and orally bioavailable molecular glue degrader directed against VAV1 in development for systemic and neurological autoimmune diseases.
Resolution Therapeutics Ltd. has received approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a phase I/II study of its lead candidate RTX-001 in patients with decompensated liver cirrhosis.
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