CGTLive’s Weekly Rewind – December 1, 2023

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. FDA to Investigate Risk of T-Cell Malignancy After CAR T-Cell Therapy

The FDA has received reports of multiple T-cell malignancies in patients after approved CAR-T treatment.

2. Marcela Maus, MD, PhD, on New Approaches to CAR T-Cell Therapy for Solid Tumors

The Associate Professor of Medicine at Harvard Medical School discussed upcoming research and strategies to combat present hurdles in the treatment field.

3. Second Gene Therapy for Epidermolysis Bullosa up for Priority Review

Pz-cel has a PDUFA date of May 25, 2024.

4. Fernanda Mesquita, PhD, on Using LAMA2-Exosomes to Improve Cardiomyocyte Survival in Stroke

The research associate at the The Texas Heart Institute discussed preclinical research she presented at AHA’s 2023 Scientific Sessions on MSC-derived exosomes.

5. Autolus Submits Obe-Cel BLA for Adult R/R B-ALL

The company also plans to submit an MAA to the EMA in the first half of 2024.