CGTLive’s Weekly Rewind – November 11, 2022

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Review top news and interview highlights from the week ending November 11, 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. CRISPR-CAR T Therapy Yields First Allogeneic Complete Response in R/R Solid Tumors

Data from the COBALT-RCC study in renal cell carcinoma were presented at SITC 2022.

2. Susan Foy, PhD, on Evaluating Personalized, Neoantigen-Specific T Cell Therapy in Solid Tumors

The CRIPSR-edited neoantigen-specific T cell therapy demonstrated safety and feasibility in the first-in-human PACT-0101 study presented at SITC 2022.

3. Gene Expression Profiles Characterize CAR T-Cells in Solid and Hematological Tumors

Further analysis will be performed to elucidate which characteristics correlate with optimal cell therapy behavior.

4. Samir Parekh, MD, on Surprising Efficacy of Sequential T-Cell Redirection Therapy in Multiple Myeloma

The director of translational research in myeloma at the Tisch Cancer Institute discussed the relevance of the new research as more CAR T therapies come to market.

5. BioMarin Prepares for PDUFA Delay for Val-Rox Hemophilia Gene Therapy

Recent communication with the FDA suggests that the agency's decision might be delayed past Q1 2023.

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Alexey Danilov, MD, PhD, the Marianne and Gerhard Pinkus Professor of Early Clinical Therapeutics, medical director of the Early Phase Therapeutics Program for the Systems Clinical Trials Office, codirector of the Toni Stephenson Lymphoma Center, and a professor in the Division of Lymphoma in the Department of Hematology & Hematopoietic Cell Transplantation at City of Hope in Duarte, California
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