Elicera Therapeutics AB has received approval from the Swedish Medical Products Agency to start a phase I/II study of chimeric antibody receptor (CAR) T-cell therapy ELC-301 in patients with refractory or relapsed B-cell lymphoma.
The Foundation for the National Institutes of Health (FNIH) has announced the online publication of the first playbook designed to help accelerate the development of adeno-associated virus (AAV) gene therapies for rare diseases.
Aprea Therapeutics Inc. has submitted an IND application to the FDA to initiate clinical trials of APR-1051, an oral next-generation small-molecule inhibitor of WEE1 kinase.
Guangzhou Fermion Technology Co. Ltd. has received IND approval by China’s National Medical Products Administration (NMPA) for its TYK2 JH2 inhibitor, FZ-007-119.
Acepodia Inc. has obtained FDA clearance of its IND application for ACE-2016, an allogeneic γδ2 T-cell therapy for the treatment of epidermal growth factor receptor (EGFR)-expressing malignancies in patients with solid tumors.
Jaguar Gene Therapy LLC’s IND application for JAG-201, a gene therapy for a genetic form of autism spectrum disorder (ASD) and Phelan-McDermid syndrome (PMS; 22q13.3 deletion syndrome), has been cleared by the FDA.
23andme Holding Co. has received FDA clearance of its IND application for 23ME-01473 (‘1473), a dual mechanism antibody and natural killer (NK) cell activator intended to treat cancer.
Ascidian Therapeutics Inc. has received FDA clearance of its IND application for ACDN-01, an RNA exon editor targeting the genetic cause of Stargardt disease.
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