Medigene AG has obtained FDA clearance of its IND application for lead program MDG-1015 for the treatment of advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma.

Medigene AG has provided a pipeline update in its half-year report for the first half of 2024. The company, which develops T cell receptor (TCR)-guided therapies for the treatment of cancer, confirmed for following positive EU and U.S. preliminary regulatory interactions, is on track for filing an IND in Q3 and a CTA in Q4 of 2024 for its lead candidate MDG-1015.

Precision Biosciences Inc. has announced that its experimental allogeneic T cell therapy azercabtagene zapreleucel (azer-cel) for the treatment of multiple sclerosis (MS) has received IND clearance from the FDA.

CSPC Pharmaceutical Group Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with its BCMA-targeting CAR T cell SYS-6020 for systemic lupus erythematosus (lupus) in China.

Tr1x Inc. has announced that the FDA has cleared its IND application for its engineered Tr1 Treg cell therapy TRX-103 for treatment-refractory Crohn’s disease.

Shinobi Therapeutics Inc. has been awarded non-dilutive grant funding of up to $59 million by the Japanese Agency for Medical Research and Development (AMED).

Cellular immunotherapy is the Lamine Yamal of cancer therapy. It is easy to forget how young the field is – and that as stunning as it is to watch in action already, it is still reaching its full potential. One aspect of doing so is working in a broader range of tumor types. The field made a giant step toward that goal with last week’s approval of Tecelra (afamitresgene autoleucel, Adaptimmune Therapeutics plc), the first CAR T cell to be approved for treatment of a solid tumor.

To be successful, CAR T-cells need a balance between being effective and overkill. Researchers from the University of Pennsylvania and Vittoria Biotherapeutics Inc. have eliminated the CD5 signaling pathway of their CAR Ts to prevent the immunosuppressive brake effect. In return, this improved their proliferation and antitumor activity in T cell lymphomas.

Umoja Biopharma Inc. has received clearance from the FDA to begin a first-in-human trial of its CAR T product UB-VV111. The company expects to dose the first patient by the end of 2024.

Astellas Pharma Inc.’s subsidiaries Astellas Institute for Regenerative Medicine (AIRM) and Universal Cells Inc. have entered into a research collaboration with Osaka University to develop a pluripotent stem cell-derived cartilage organoid cell therapy for the treatment of intervertebral disc degenerative disease.