Therapeutic Class

J&J preps to enter cell therapy space as CAR-T approval decision approaches

J&J says it will learn from pioneers in the cell therapy space as it preps its production network for the potential launch of its BCMA CAR-T product. J&J division Janssen Biotech entered the cell and gene therapy space in 2017, teaming up with Legend Biotech for the development of ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor (CAR) T-cell candidate specifically targeting the B-cell maturation antigen (BCMA) and is known as LCAR-B38M in China . Nearly four years on, and the…

Boehringer’s adalimumab becomes first interchangeable mAb biosimilar

The US FDA has approved Boehringer Ingelheim’s Cyltezo as the first biosimilar interchangeable with AbbVie’s blockbuster monoclonal antibody Humira (adalimumab). While biosimilars have offered cheaper versions of biological drugs in the US for six years, the issue of interchangeability has muddied the waters. An interchangeable biosimilar is one that can be substituted at the pharmacy level for the reference product without the prescriber having to change the prescription. Interchangeability is an additional standard beyond the requirement for biosimilarity and thus…

Room for both allogeneic and autologous in cell therapy space

Allogeneic products may dominate the cell therapy sector thanks to tech and cost advantages but there will always be room for autologous treatments say experts. Cell therapies are either allogenic – derived from a universal donor – or patient-specific, autologous products. The products treat disease in the same way, what differs is the types of immune responses they generate and the process used to make them. And – according to a panel of experts at the BPI East conference in…

Avid turns to viral vector production on back of strong CGT growth

CDMO Avid Bioservices will expand its biomanufacturing services to include viral vector development and production, investing up to $75 million in a California facility. Biologics contract development and manufacturing organization (CDMO) Avid Bioservices revealed today to build a 53,000 square foot viral vector development and GMP manufacturing facility in Costa Mesa, California at a cost of between $65 million to $75 million. The facility, which could be operational within two years, will initially support projects up to 200 L using…

Standardized AAV manufacturing: Why are AAV reference materials needed?

The field of gene therapy is in great need for well characterized AAV reference materials, according to viral vector delivery services firm Vigene Biosciences. Recombinant adeno-associated virus (rAAV) is a widely used gene delivery tool for research and clinical applications in the gene therapy field. To compare the pharmacokinetics and efficacy of rAAV, well characterized AAV reference materials are needed for assays and in-house reference materials calibration. AAV reference materials are also essential for AAV in process development and AAV…

Iovance opens PA cell therapy plant; produces first batch of lifileucel

The $85 million Iovance Cell Therapy Center (ICTC) has opened its doors at the Philadelphia Navy Yard with capacity to supply thousands of patients per year. Iovance celebrated the opening of its 136,000 square-foot commercial-scale production facility, commissioned in 2018 at a cost of around $85 million, this week. “Since Iovance was founded, we have been dedicated to advancing novel cell therapies for patients with solid tumor cancers,” Iovance CEO Frederick Vogt said. “A little over two years after breaking…

Gilead: ‘Cell therapy is at the very early stages of its penetration’

Gilead Sciences says the advent of cell therapies into second line treatments and increased competition in the space will help boost the “under-penetrated” market. Having entered the cell and gene therapy space in August 2017 through the $11.9 billion acquisition of Kite Pharma, Gilead Sciences has cemented itself as a pioneer in the sector through the commercialization cell therapies: Yescarta (axicabtagene ciloleucel), approved in the US in October 2017, and Tecartus (brexucabtagene autoleucel) approved in July 2020. According to Gilead’s CEO…

Pfizer: Trial management and manufacturing key to DMD gene therapy success

Pfizer has stressed the importance of having the right manufacturing capabilities as it looks to be first to market with its gene therapy for Duchenne muscular dystrophy (DMD). Orphan disease DMD is an X-linked disorder caused by mutations in the gene encoding dystrophin, which is needed for muscle membrane stability. The disease affects around 140,000 boys worldwide, 30,000 of which are in the US and Europe. Most of the current treatments do not address the underlying cause, but gene therapies…

Flash drive: French CDMO to scale up viral vector production

Flash Therapeutics has secured a three-year funding deal to help further develop its LentiFlash viral vector tech and to double its manufacturing capacity. The Toulouse, France-based contract development and manufacturing organization (CDMO) has developed its own lentiviral platform, LentiFlash, for use as a delivery vector in vaccinations, regenerative medicine, and gene-editing applications. “LentiFlash technology leads to a transient expression mediated by RNA delivery as lentiviral-based therapies leads to stable expression mediated by DNA delivery,” a spokesman from the firm told…

Seqirus looks to next-gen mRNA for seasonal flu vaccine

Seqirus says it will look to build large-scale manufacturing capacity to support its self-amplifying messenger RNA (sa-mRNA) ambitions in the seasonal influenza space. Seqirus has long had a leading role in the seasonal influenza space through its portfolio of products, including both egg-based and cell-based vaccine. But now the firm is stepping up its efforts to develop a flu vaccine based on mRNA, launching a dedicated program to support development of its next-generation sa-mRNA platform with plans to set up…