CGTLive®’s Weekly Rewind – August 8, 2025

Welcome to CGTLive®’s Weekly Rewind! We’ve compiled 5 highlights from this week’s coverage of advances in gene and cell therapies, including FDA actions, notable research, and interviews with experts across the field.

1. INmune Bio's INKmune Hits End Points in mCR Prostate Cancer Trial

INmune Bio reported that INKmune was well-tolerated at the 3 dose level used in the trial.

2. Rajeev Sivasankaran, PhD, on Voyager’s Single-Dose AAV Strategy for Silencing Tau for Alzheimer Disease

The vice president of neuroscience at Voyager Therapeutics shared preclinical data on the company’s AAV-delivered RNA interference therapy, VY-1706.

3. Patient Dies After Receiving Monoclonal Antibody Lymphodepletion Regimen in LBCL Trial for Allogene’s Cema-Cel

The patient’s death was attributed to antiCD52 monoclonal antibody ALLO-647 rather than to cema-cel itself.

4. FDA Gives Priority Review to BMS’s Supplemental BLA for Liso-Cel in R/R Marginal Zone Lymphoma

The PDUFA goal date for the sBLA has been set for December 5, 2025.

5. Sensorion Finishes Enrolling Patients in Second Cohort of its Phase 1/2 Trial for Congenital Deafness Gene Therapy SENS-501

The therapy is intended to restore hearing and support early speech development in children with OTOF-related congenital deafness.