KSQ Therapeutics Inc., in collaboration with The University of Texas MD Anderson Cancer Center and the Cell Therapy Manufacturing Center (CTMC), have announced FDA clearance of an IND application for a phase I/II study of KSQ-001EX, KSQ’s lead engineered tumor-infiltrating lymphocyte (eTIL) program.
Carisma Therapeutics Inc. has received FDA clearance of its IND application for CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor (CAR)-monocyte cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2).
Sernova Corp. has announced that its hemophilia A program, combining the Sernova Cell Pouch with a patient’s own cells corrected for the production of factor VIII (FVIII), has been awarded U.S. orphan drug and rare pediatric disease designations.
The Swedish Medical Products Agency has authorized Uppsala University's clinical trial application to initiate an investigator-sponsored, first-in-human study of UP-421, an allogeneic, primary islet cell therapy engineered with Sana Biotechnology Inc.'s hypoimmune technology, in patients with type 1 diabetes.
Researchers from Adicet Bio Inc. reported on the preclinical development of ADI-925, an engineered Chimeric Adapter (CAd) γδ1 T-cell therapy that targets major histocompatibility complex class I chain-related protein A/B (MICA/MICB) and ULBP1-6 expressed in tumor cells.
Itolerance Inc. and Kadimastem Ltd. have submitted a meeting request to the FDA's INTERACT committee for ITOL-102, which is under development as a potential cure for type 1 diabetes without the need for chronic immunosuppression.