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Home » Topics » Drugs » Cell therapy

Cell therapy
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Omniabio building

Medipost grows US, Canada base; plans US phase III of Cartistem

Jan. 15, 2025
By Marian (YoonJee) Chu
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.
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JPM: CBER’s Marks ‘reassured’ as FDA to refine warnings on CAR Ts

Jan. 15, 2025
By Nuala Moran
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.
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Immuno-oncology

New CAR T-cells target CD79b for non-Hodgkin lymphoma

Jan. 15, 2025
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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3d illustration of ovarian cancer
Immuno-oncology

ERNA-101 extends survival in mice with ovarian cancer

Jan. 15, 2025
Eterna Therapeutics Inc. has released promising results from a preclinical study of its lead cell therapy product, ERNA-101, showing it reduced tumor burden and extended survival in mice with ovarian cancer.
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DNA in drug capsules

Alliance for Regenerative Medicine: Field growing, cost still an issue

Jan. 14, 2025
By Nuala Moran
The accelerating pace of U.S. FDA approvals for cell and gene therapies is “great for the field and great news for the patients,” but questions remain over commercialization, with “costs remaining stubbornly high.” That was the glass half-full summary of Tim Hunt, president of the industry group, the Alliance for Regenerative Medicine, reprising progress in 2024, and looking forward to the prospects for further growth and the potential impact of the incoming Trump administration in 2025.
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Stem cells
Neurology/psychiatric

Ips Heart’s stem cell therapy designated orphan drug for Becker muscular dystrophy

Jan. 14, 2025
Ips Heart Inc. has been awarded orphan drug designation by the FDA for its GIVI-MPC stem cell therapy for Becker muscular dystrophy. GIVI-MPC has the unique ability to create new muscle with full length dystrophin in Becker muscular dystrophy.
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Wooden stamp with China flag

China’s NMPA clears country’s first mesenchymal stem cell therapy

Jan. 8, 2025
By Marian (YoonJee) Chu
China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan. 2, 2025.
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Early data validate Vir’s newly acquired dual-masked TCE therapies

Jan. 8, 2025
By Jennifer Boggs
Vir Biotechnology Inc.’s 2024 deal with Sanofi SA is starting to look like a pretty savvy move. The company, which picked up three clinical-stage dual-masked T-cell engagers (TCEs) and rights to the platform technology as part of a pipeline overhaul, reported phase I data for TCE programs targeting HER2 and PSMA that indicated promising efficacy with a low prevalence of the cytokine toxicity that has hampered other TCE programs.
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Rendering of hypoimmune cells

Type 1 diabetes breakthrough? Sana threads key ‘islet,’ SC-451 to advance

Jan. 8, 2025
By Randy Osborne
Sana Biotechnology Inc. CEO Steve Harr said “cool and transformative science” led to his firm’s latest strides in type 1 diabetes, and the “very generalizable [clinical] result” cheered Wall Street, which led shares of the Seattle-based firm (NASDAQ:SANA) to close Jan. 8 at $4.30 up $2.65, or 160.6%. “I believe we now have all of the pieces in place to move forward rapidly,” Harr said.
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Wooden stamp with China flag

China’s NMPA clears country’s first mesenchymal stem cell therapy

Jan. 7, 2025
By Marian (YoonJee) Chu
China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan. 2, 2025.
Read More
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