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.

CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with the first mRNA-lipid nanoparticles (LNP)-based CAR T-cell injection, SYS-6020.

Adicet Bio Inc. has obtained FDA clearance of its IND application to evaluate ADI-270, an armored allogeneic λδ CAR T-cell therapy candidate targeting CD70-positive cancers, for the treatment of relapsed or refractory renal cell carcinoma (RCC).

4D Molecular Therapeutics Inc. has obtained IND clearance by the FDA for 4D-175, an R100 vector-based intravitreal genetic medicine, for the treatment of patients with geographic atrophy.

Genfleet Therapeutics (Shanghai) Co. Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to advance GFH-375 (VS-7375) into a phase I/II study in patients with advanced solid tumors with KRAS G12D mutation.

Zymeworks Inc. has obtained IND clearance from the FDA for ZW-171, a novel T-cell targeting bispecific antibody for mesothelin (MSLN)-expressing cancers. Clinical development will begin this year, and additional applications will be filed in the second half of the year seeking trial clearances in other territories.