Create Medicines Inc. has received Human Research Ethics Committee (HREC) approval in Australia to initiate a first-in-human study of CRT-402, the company’s lead in vivo CAR T candidate for the treatment of autoimmune diseases.
Dyne Therapeutics Inc. has obtained IND clearance from the FDA for DYNE-302 in facioscapulohumeral muscular dystrophy (FSHD), a rare, genetic disease caused by a mutation in the DUX4 gene. Dyne plans to conduct a phase I trial in ambulatory adults with FSHD.
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. said its IND application was approved in China for SKB-565, its dual-payload antibody-drug conjugate (ADC), for the treatment of advanced solid tumors.
Camp4 Therapeutics Corp. has received clearance to initiate a phase I/II clinical trial of CMP-002, a potential first-in-class therapeutic for SYNGAP1-related disorder.
Abera Bioscience AB has announced, together with clinical partner Radboud University Medical Center, the submission of a clinical trial application in the Netherlands to initiate a phase I trial of its serotype-independent pneumococcal vaccine candidate AB-01.12.
Scientists in Europe have added their voices to the many thousands of objections made against proposed changes to the oversight of U.S. federal research grants, under which political appointees and not peer review experts would have the final say on who and what gets funding. The concern is that awarding grants, based on the principle that research proposals must be in keeping with President Donald Trump’s policy priorities, poses a threat to open scientific inquiry and academic freedom, and also will undermine international research collaboration.
Fosun Pharma subsidiary Fosun Pharmaceutical Industrial Development (Shenzhen) Co. Ltd. has received approval from China’s National Medical Products Administration (NMPA) to commence clinical trials for FXR-0906 for the treatment of hypertriglyceridemia.
Atrium Therapeutics Inc. has obtained IND clearance from the FDA for ATR-1072 for the treatment of protein kinase AMP-activated non-catalytic subunit γ2 (PRKAG2) syndrome.
Niagen Bioscience Inc.’s proprietary lead small-molecule drug candidate, NB-4168, has been awarded European orphan drug designation and U.S. rare pediatric disease designation for the treatment of ataxia telangiectasia.