Astria Therapeutics Inc. has gained IND clearance from the FDA for STAR-0310, a monoclonal antibody OX40 antagonist being developed for atopic dermatitis.
Nextcure Inc. has reported IND clearance from the FDA enabling initiation of a phase I trial of LNCB-74, a B7-H4-targeting antibody-drug conjugate (ADC) being developed for various cancers.
Base Therapeutics (Shanghai) Co. Ltd.’s NK-510 cell injection, a zero-off-target base-edited natural killer (NK) cell product, has received approvals to start clinical trials from both the U.S. FDA and China’s NMPA for clinical trials for advanced solid tumors.
Beijing Avistone Biotechnology Co. Ltd. has obtained IND clearance from the FDA for ANS-03, a next-generation tyrosine kinase inhibitor (TKI) targeting both ROS proto-oncogene 1 (ROS1) and neurotrophic tropomyosin receptor kinase (NTRK).
Alveogene Ltd. has announced its novel inhaled gene therapy for lethal neonatal surfactant protein B (SP-B) deficiency, AVG-002, has been awarded orphan drug designation by the FDA.
Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells.