Therapeutic Class

Gilead says CA plant will supply Yescarta to EU until 2020

Kite’s manufacturing plant in El Segundo, California, will supply Europe with the newly approved CAR-T therapy Yescarta while a facility in The Netherlands is being prepared. Gilead Sciences has received marketing authorization from the European Commission (EC) for its chimeric antigen receptor T (CAR-T) cell therapy Yescarta (axicabtagene ciloleucel). The therapy is approved to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL). “Across the European Union, it is estimated that…

Mustang to make ‘bubble boy’ candidate from newly opened cell therapy plant

A gene therapy for children with X-linked severe combined immunodeficiency (X-SCID) will be made at Mustang Bio’s facility in Massachusetts, which opened in June. Biotech firm Mustang Bio has partnered with St. Jude Children’s Research Hospital to develop a lentiviral gene therapy for the rare disease, commonly known as bubble boy disease, caused by a lack of immune cells necessary to fight off viruses, bacteria and fungi. As the therapy progresses through early-phase clinical trials, Mustang will begin to manufacture…

WuXi Biologics launches bispecific antibody tech

WuXi Biologics says it can expedite the development of bispecific antibodies by up to 18 months compared to current offerings through its new ‘WuXiBody’ platform. The Chinese contract development and manufacturing organization (CDMO) WuXi Biologics announced the additional service offering during its 2018 interim results and said its proprietary tech can potentially transform the bispecific industry. “We can take any two sequences of the MAbs [monoclonal antibodies] and engineer into WuXiBody bispecific in two to three months. The resulting bispecifics…

Astellas paying $110m for UK-based gene therapy firm

The acquisition of Quethera accelerates Astellas Pharma’s entry into the ophthalmic gene therapy space, the firm says. Japanese drugmaker Astellas has bought Cambridge, UK-based preclinical biotech for as much as £85 million (US$110 million) and will take over development of its lead candidate, a proposed gene therapy for the treatment of refractory glaucoma through an intraocular pressure (IOP)-independent mechanism. “This acquisition demonstrates Astellas’ commitment to proactively incorporate state-of-the-art scientific and technological advances and turn them into value for patients,” a…

Samsung Bioepis: From biosimilars to novel biologics

Following success with several biosimilars, bringing a novel biologic into the clinic is the “next logical step” in becoming a fully integrated biopharma firm, says Samsung Bioepis. Almost a year to the date it announced a co-development agreement, Samsung Bioepis and Takeda Pharmaceuticals are preparing to begin a Phase I trial for its lead candidate, SB26, also known as TAK-671. The news signals the latest stage in the development of Samsung Bioepis – a joint venture between South Korean contract…

Alnylam’s success brings first RNAi therapeutic to US

The US Food and Drug Administration (FDA) has approved the first ever RNA interference (RNAi) therapy: Alnylam’s Onpattro (patisiran). Alnylam announced last week Onpattro has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. The product was hailed by the FDA as the first in a new class of drugs: small interfering ribonucleic acid (siRNA) treatments. “New technologies like RNA inhibitors, that alter the genetic drivers of a disease, have the…

Anti-antibody anybody? Bio-Rad range to target Lucentis biosimilar developers

Bio-Rad has launched a range of anti-ranibizumab antibodies for PK and immunogenicity assays on the back of increased Lucentis biosimilar development. Bio-Rad Laboratories will offer customers a range of recombinant monoclonal anti-ranibizumab antibodies that are highly specific for Lucentis (ranibizumab), or the complex of ranibizumab with its target, vascular endothelial growth factor A (VEGF-A). The anti-antibodies are to be used in pharmacokinetic (PK) and immunogenicity assays, and the product launch is due to the increased interest in Lucentis biosimilar development,…

Regeneron teams up and takes $100m stake in bluebird bio

Regeneron has increased its interest in cellular therapies through a T cell co-development partnership with bluebird bio. The deal sees Regeneron Pharmaceuticals and bluebird bio combine their respective tech platforms to discover, develop and commercialize an initial six candidates against tumor-specific proteins and peptides, including chimeric antigen receptor (CAR) T and other T cell receptors (TCRs). As part of the collaboration, Regeneron has invested $100 million (€87 million) in its new partner bluebird, buying 420,000 shares at a price of…

Esco Aster to transfer CAR-T tech to Chinese biomanufacturing plant

The Singapore-based CDMO will fit out Wuhan Bio-Raid Biotechnology’s facility in China with its lentiviral vector platform and bioproduction technologies. Esco Aster has signed a memorandum of understanding (MoU) to use its lentiviral vector platform and bioproduction technologies to support Wuhan Bio-Raid’s chimeric antigen receptor (CAR) T-cell therapy pipeline in China. “Under the MoU, both parties have achieved a broad understanding to increase the speed of CAR-T development in China,” Esco Aster spokesperson Ai San Yip told BioProcess Insider. This…

BioTime spinning out regenerative med firm AgeX

BioTime has received US$43 million (€37 million) from Juvenescence for a stake in AgeX and plans to spin the cell therapy subsidiary out in September. In April 2017, Californian late-stage biotech BioTime formed the subsidiary AgeX therapeutics to focus on its human aging candidates derived from regenerative stem cells. Earlier this year, fellow aging-focused firm Juvenescence made a $5 million investment in the subsidiary, and this week has upped its stake by 14.4 million shares paying BioTime $21.6 million in…