Cell Therapies
Kyoto-based venture moves HQ to California to expand R&D and business outreach for its regulatory T-cell technology, as it raises around $46m in public and private funding.
The promise of innovative therapies seems to have been constrained not by efficacy or safety concerns, but because the high price of treatments is incongruous with the reimbursement of short-course therapies.
Miltenyi’s leadership calls for a streamlined regulatory framework as India gears to scale in cell and gene therapy. Executives from the German group also talked to Scrip about helping advance local capabilities, delivering point-of-care CAR- T cell therapy to hospitals and pricing dynamics.
The biotech announced positive Phase III data for Orca-T, its allogeneic cell therapy, and a company cofounder talked with Scrip about Orca’s commercialization plans.
The acquisition is worth up to $1bn and adds to AstraZeneca’s broad array of cell therapy technologies.
The big pharma will spend $286m to acquire the biotech, which restructured in January 2024 to focus exclusively on their shared product, the CAR-T Abecma.
Cross-Asian initiative has already brought several South Korean gene and cell therapy startups and Japanese VCs closer, with further hopes for product development and launches in Japan, regulatory harmonization and gliobalization.
Over 140 biopharma leaders share their views on developments to watch for in key therapeutic areas this year. Advances in multiple scientific fields are opening up new avenues for treatment.
Rimqarto is poised to become the first homegrown South Korean CAR-T therapy to gain domestic approval and looks set to provide new local competition to Kymriah.
Cancer retained its crown as 37 novel drugs were approved for pan-EU marketing last year; treatments for blood disorders followed closely behind in what was another slow year at the European Medicines Agency.
The FDA placed a clinical hold on the cell therapy firm’s active INDs that affects Ebvallo and ATA3219 and is connected to the recent complete response letter for Ebvallo.
The Pierre Fabre-partnered allogeneic T-cell immunotherapy is already available in Europe but hopes of a US approval have been hit by a complete response letter citing problems at a third-party manufacturing facility.
Following promising Phase II data presented at ASH on the company's allogenic leukemia-derived dendritic cell vaccine, Mendus has secured support from the FDA and the EMA for pivotal studies starting later this year.
CARsgen's anti-Claudin 18.2 CAR-T therapy satricabtagene autoleucel has met its endpoint in a pivotal Phase II trial in later-stage gastric/gastroesophageal junction adenocarcinoma, paving the way for a China NDA filing.
The cell therapy won approval for pediatric steroid-refractory acute graft versus host disease after two complete response letters over the last four years.
The struggling Japanese pharma group is aiming to grow its new cell therapy business in the US and Japan to $2.3bn by the late 2030s.
BMS presented Phase I data for arlocabtagene autoleucel, showing a strong median PFS and lower incidence and severity of trouble swallowing, a common side effect of anti-GPRC5D drugs.
Multiple myeloma patients in the iMMagine-1 study were less heavily pretreated than in the CARTITUDE-1 trial of Carvykti, but Gilead noted that more patients receiving anito-cel had high-risk features.
The Swiss drug maker presented Phase II data at ASH for rapcabtagene autoleucel, also called YTB323, showing a 65% CR rate in relapsed/refractory diffuse large B-cell lymphoma.
Both companies are seeking to license their products as they try to stretch their dwindling cash.