T-Curx GmbH has obtained clinical trial approval from the Swiss agency Swissmedic for the company’s nonviral lead CAR T program, TCX-001. The first-in-human phase I study will open in Switzerland, and a submission to the EMA will seek to expand the trial to sites in Germany. The study will enroll adults with relapsed or refractory acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL), including patients not eligible for stem cell transplantation.

Antengene Corp. Ltd. has obtained IND approval from China’s National Medical Products Administration (NMPA) for ATG-201 for the treatment of B-cell related autoimmune diseases.

Sensorion SA has selected SENS-601 (GJB2-GT) as its lead program and has filed clinical trial applications to study its use for GJB2-related hearing loss. SENS-601 is an AAV-based gene therapy program, utilizing a gene therapy platform codeveloped with Institut Pasteur.

Gen1e Lifesciences Inc. has obtained both orphan drug and rare pediatric disease designations from the U.S. FDA for GEn-1123 for the treatment of Duchenne muscular dystrophy (DMD).

The University of Oxford and Moderna Inc. have announced authorization by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a phase I/II study of mRNA-4194, Moderna’s investigational mRNA-based cancer vaccine for Lynch syndrome.

Hansoh Pharmaceutical Group Co. Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for HS-10541 tablets.

Amphista Therapeutics Ltd. has obtained IND clearance from the FDA for AMX-883, an orally bioavailable degrader of BRD9, for the treatment of acute myeloid leukemia (AML). A phase I trial in patients with relapsed or refractory AML and high-risk myelodysplastic syndrome is expected to begin in the second half of this year.

Sotio Biotech AS’s SOT-106 has been granted orphan drug designation by the FDA for the treatment of osteosarcoma. SOT-106 is a next-generation antibody-drug conjugate targeting leucine-rich repeat-containing 15 (LRRC15), a clinically validated target broadly expressed across sarcoma subtypes and in tumor-associated stroma.

CSPC Pharmaceutical Group Ltd. has obtained clinical trial clearance from China’s National Medical Products Administration (NMPA) for SYS-6063, an mRNA-LNP-based dual-target CAR T-cell injection for the treatment of relapsed or refractory systemic lupus erythematosus (SLE).

Iovance Biotherapeutics Inc. has received IND clearance from the FDA for IOV-5001, a next-generation interleukin-12 (IL-12)-tethered tumor-infiltrating lymphocyte (TIL) therapy.