CGTLive’s Weekly Rewind – September 2, 2022

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. Iovance Starts BLA Submission of Lifileucel for Advanced Melanoma

The tumor-infiltrating lymphocyte therapy has shown efficacy in the phase 2 C-144-01 trial.

2. CARsgen Advances Autologous CAR T Therapies in Multiple Myeloma, Advanced Gastric Cancer

The company has initiated the world’s first confirmatory phase 2 trial of a CAR T-cell therapy in solid tumors.

3. Mark Forman, MD, PhD, on ICM Administration of Gene Therapy in Frontotemporal Dementia

The chief medical officer of Passage Bio discussed the phase 1/2 upliFT-D study of PBFT02.

4. FDA Recognizes CRISPR Therapy for Treatment of Hereditary Angioedema

The in vivo genome-editing therapy is the first gene therapy to be evaluated in a clinical trial for preventing HAE attacks.

5. Phase 3 Heart Failure Cell Therapy Trial Receives Go-Ahead from DSMB

The risk-benefit assessment determined that there are no significant safety concerns.