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ASGCT Members Provide Recommendations During FDA Liaison Meeting
ASGCT held its fifth annual liaison meeting with FDA CBER’s Office of Tissues and Advanced Therapies (OTAT) on Nov. 14, 2022. A group of Society leaders and members gave two presentations to FDA on significant topics in the field, followed by a presentation from FDA. Dr. Keith Wonnacott, ASGCT’s Regulatory Affairs Committee Chair, chaired the meeting and moderated discussion...
CG Oncology advancing clinical-stage urologic oncology immunotherapy pipeline
Company files its first Investigational New Drug application for its lead program KYV-101, a novel fully human CD19 CAR T-cell therapy, for the treatment of lupus nephritis. Kyverna’s therapeutic platform combines advanced T-cell engineering and synthetic biology technologies to suppress and eliminate...
Quantification of On/Off-Target Gene Editing
Quantitative analysis of gene editing is now an essential step in getting regulatory approval of gene editing-based therapies. But designing and validating assays for on/off-target editing analysis and building an internal team to perform them can be costly and inefficient...
CHOP Study Offers Proof of Concept for Treating Pediatric Brain Tumors with Immunotherapy
Although immunotherapy has revolutionized the treatment of many blood cancers, the field has encountered challenges developing similar treatments for solid tumors. When it comes to pediatric brain tumors, which are the leading cause of cancer death in children, challenges include...
Remarkable results from CAR-T cell therapy for lupus
A recent study has shown remarkable results from compassionate use of CAR-T cell therapy to treat severe lupus in five patients in whom multiple other treatments had previously failed. CAR-T cell therapy involves genetically engineering T cells, a type of immune cell, so that they respond to a prespecified molecular marker, or antigen. This means they mount an immune response against cells with the chosen antigen...
Kyverna Therapeutics Submits IND for Novel CAR T-Cell Therapy to Treat Lupus Nephritis
Company files its first Investigational New Drug application for its lead program KYV-101, a novel fully human CD19 CAR T-cell therapy, for the treatment of lupus nephritis. Kyverna’s therapeutic platform combines advanced T-cell engineering and synthetic biology technologies to suppress and eliminate...