Cell Therapies
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.
Aucatzyl will look to take market share from Gilead’s Tecartus, and the US approval is a boost for the firm and the wider UK biotech sector.
The drug maker said in its third quarter earnings report that competition from other therapeutic classes, particularly bispecifics, resulted in a slight decline of sales for the CAR-T.
The otherwise encouraging data were marred by one patient death, but the company attributed it to the busulfan conditioning regimen and not BEAM-101.
Lyell believes ImmPACT’s dual CD19/20-targeted CAR-T could offer better response rates than Yescarta or Breyanzi and will focus on IMPT-314 while terminating much of its own pipeline.
Multiple Japanese ventures presented updates on their novel pipeline assets and modalities at BioJapan, including cell and gene therapies and combination treatments, despite lingering financing challenges.
ARM’s Cell and Gene Meeting on the Mesa offered optimism that a biopharma financial market recovery is under way, but cell and gene therapies still are seen as risky investments.
Emerging Company Profile: The Maryland-based biotech is working on a functional cure for type 1 diabetes that is similar to Vertex’s VX-880 – but with some key differences.
Big pharma executives at ARM’s Cell and Gene Meeting on the Mesa shared some of the practical challenges of bringing one-time treatments to market in hemophilia, cancer and beyond.
With more advanced therapies gaining approval, companies at ARM’s Cell and Gene Meeting on the Mesa considered hurdles to making their products more broadly available and developing them for larger indications.
In a video interview with Scrip, Syed Husain, CEO of the US-based cell therapy CDMO BioCentriq, talks about the company’s role in parent GC’s growth strategy and business priorities, the cell and gene therapy manufacturing market and his views on the US BIOSECURE Act.
In this week's podcast edition of Five Must-Know Things: summer ADC dealmaking continues apace; a look at cell therapies in Japan; Pfizer’s new US digital consumer platform; Galapagos’s US point of care CAR-T study; and Novartis partners with Lindy on biologics delivery.