To realize the promise of cell therapy for neurodegenerative disorders, S.Biomedics Co. Ltd. is looking to expand clinical trials of TED-A9, its stem cell therapy for Parkinson’s disease (PD), to the U.S., having reaped positive results from a domestic phase I/IIa trial in November 2024.
In a devastating blow to the company and large B-cell lymphoma patients relapsed or refractory to CD19 CAR T-cell therapy, Cargo Therapeutics Inc. terminated the phase II study of its lead CD22 cell therapy, firicabtagene autoleucel (firi-cel), and is cutting its workforce by 50% and evaluating strategic options, following disappointing data on durability of response and serious safety events, some of which were fatal.
Swarm Oncology Ltd. has emerged from stealth with a focus on advancing novel T-cell therapies to achieve long-term remission in patients with advanced solid cancers.
To realize the promise of cell therapy for neurodegenerative disorders, S.Biomedics Co. Ltd. is looking to expand clinical trials of TED-A9, its stem cell therapy for Parkinson’s disease (PD), to the U.S., having reaped positive results from a domestic phase I/IIa trial in November 2024.
As more Asia biotechs turn to regenerative medicine to address disorders without a cure, Medipost Inc. is continuing global expansion with Cartistem, its allogeneic human umbilical cord blood-derived mesenchymal stem cell product that gained clearance in South Korea in 2012 to treat knee osteoarthritis.
Atara Biotherapeutics Inc. received a complete response letter (CRL) from the U.S. FDA for its lead product, Ebvallo (tabelecleucel), a breakthrough therapy for Epstein-Barr virus positive post-transplant lymphoproliferative disease that is already approved in the EU, the U.K. and Switzerland.
TC Biopharm (Holdings) plc intends to begin proof-of-concept preclinical studies for its lead therapeutic TCB-008, to treat H5N1, or bird flu. TCB-008 is an allogeneic, unmodified cell therapy comprised of activated and expanded γδ T cells.
As more Asia biotechs turn to regenerative medicine to address disorders without a cure, Medipost Inc. is continuing global expansion with Cartistem, its allogeneic human umbilical cord blood-derived mesenchymal stem cell product that gained clearance in South Korea in 2012 to treat knee osteoarthritis.
The U.S. FDA is to temper the alert it put out in November 2023 pointing to a potential risk of CAR T therapies causing de novo malignancies. “There was this issue of possible safety concerns with T-cell lymphomas, with these CAR T cells. I think this year, we are feeling reassured in this regard,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), told the Alliance for Regenerative Medicine briefing at the J. P. Morgan Healthcare Conference on Jan. 13.
A new study published in the Journal for Immunotherapy of Cancer has presented a promising advancement in chimeric antigen receptor (CAR) T-cell therapy for non-Hodgkin lymphoma (NHL).
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