CGTLive®’s Weekly Rewind – January 17, 2025
Review top news and interview highlights from the week ending January 17, 2025.
CGTLive®’s Weekly Rewind
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 Issues CRL for Atara Biotherapeutics’ BLA for T-Cell Immunotherapy Tabelecleucel for EBV+ PTLD
The CRL was related inspection of a third-party manufacturer rather than any efficacy or safety concerns regarding the product itself.
2. Georg Schett, MD, on Future Goals for CAR-T in Autoimmune Disease
The vice president research and chair of internal medicine at the University of Erlangen – Nuremberg discussed potential upcoming innovations in the field.
3. ViGeneron Snags FDA Rare Pediatric Disease Designation for CNGA1-Associated Retinitis Pigmentosa Gene Therapy VG901
In addition to the new designation, ViGeneron also announced that the data safety monitoring board for the trial has given the green light for dose escalation.
4. Transplant Eligibility Versus CAR-T Eligibility
Manali Kamdar, MD, the associate professor of medicine–hematology and clinical director of lymphoma services at the University of Colorado, discussed the importance of referring patients with r/r LBCL who are transplant ineligible for CAR-T treatment.
5. Ocugen’s Retinitis Pigmentosa Gene Therapy OCU400 Sustains or Improves Visual Function in 2-Year Follow-Up Data
Among 9 patients treated in the study who were evaluable at 2 years posttreatment, all 9 showed improved or preserved visual function in comparison to their untreated fellow eyes.
Transplant Eligibility Versus CAR-T Eligibility
January 16th 2025Manali Kamdar, MD, the associate professor of medicine–hematology and clinical director of lymphoma services at the University of Colorado, discussed the importance of referring patients with r/r LBCL who are transplant ineligible for CAR-T treatment.
Sequencing of Treatment in Third-Line R/R LBCL
January 15th 2025Manali Kamdar, MD, the associate professor of medicine–hematology and clinical director of lymphoma services at the University of Colorado, discussed the choice between treating patients with liso-cel or bispecific T-cell engagers.
