Therapeutic Class

Pfizer to make Vivet’s Wilson disease gene therapy for Phase I/II trial

Pfizer will make a candidate gene therapy for the liver condition Wilson disease under an agreement with Vivet Therapeutics. The US pharmaceutical firm will make supplies of the candidate – known as VTX-801 – for a Phase I/II clinical trial due to start early next year. Wilson disease is characterized by the accumulation of copper in tissue. It is an inherited disorder caused by mutations in the gene encoding the ATP7B copper transporter. VTX-801 is an AAV liver tropic capsid…

Takeda opens MA manufacturing unit to support cell therapy R&D

The 24,000 square-foot cell therapy manufacturing facility will produce material through to Phase IIb trials, supporting Takeda’s cell therapy ambitions. In 2019, Takeda expanded its presence in the oncology cell therapy space inking a series of deals and establishing an internal translational cell therapy engine. To support this, the firm invested in a cell therapy manufacturing center at its R&D headquarters in Boston, Massachusetts which opened this week. “The R&D cell therapy manufacturing facility will produce cell therapies for clinical…

Exelixis: Deals with NBE and Catalent bring multi-pronged ADC approach

The antibody-drug conjugate (ADC) space has evolved significantly from its first-generation of products says Exelixis, which is increasing its presence in the sector through a pair of deals. “Exelixis has a long history of success in small molecule drug discovery and development, rooted in an approach that focuses on understanding cancer biology and applying our expertise and technology to build therapies that address it,” Peter Lamb, chief scientific officer at Exelixis, told this publication. Cabometyx (cabozantinib), Cometriq (cabozantinib), Cotelic (cobimetinib)…

Lumen Bioscience lands $16m to engineer “edible” antibody drugs

If Lumen Bioscience achieves its goals, patients will be able to take its drugs the same way some people supplement breakfast: a spoonful heaped onto a bowl of cereal or mixed into juice. The startup harnesses spirulina, protein-rich cyanobacteria touted by many health enthusiasts as a “superfood.” Lumen CEO Brian Finrow acknowledges spirulina’s health benefits, but that’s not why his company embraces it. Seattle-based Lumen turns spirulina into tiny factories that churn out therapeutic antibodies. Finrow says the Lumen technology…

ADC approval flurry a driver in MilliporeSigma $65m WI expansion

With five US FDA approvals over the past 15 months, MilliporeSigma says it is confident that antibody-drug conjugates (ADCs) will continue to be a driver of new therapeutics for years to come. A $65 million expansion in Wisconsin aims to exploit this. The Madison, Wisconsin expansion will bring MilliporeSigma’s contract manufacturing wing large-scale manufacturing capacity for high-potent active pharmaceutical ingredients (HPAPIs). The 70,000 square-foot facility will be designed to handle single-digit nanogram occupational exposure limit materials and will incorporate containment…

Catalent investing $130m to up US gene therapy capacity

Catalent will add five additional Phase III through to commercial-scale manufacturing suites to its gene therapy campus in Harmans, Maryland. The US contract development and manufacturing organization (CDMO) cited growing customer pipelines and an increase in demand as the driver for the investment. Randy Hendrickson, VP Commercial Operations, Catalent Cell & Gene Therapy told us: “Upon completion in the first half of 2022, the facility will house multiple cGMP manufacturing suites with pre-seed, bioreactor, and downstream rooms alongside fill/finish, testing,…

As COVID disrupts FDA inspections, will liso-cel approval be further delayed?

Coronavirus-related constraints mean the US FDA has not yet inspected manufacturing facilities in Washington and Texas, risking a delay in the approval of Bristol-Myers Squibb’s lymphoma CAR-T candidate liso-cel. Bristol-Myers Squibb added anti-CD19 targeting lymphoma candidate lisocabtagene maraleucel (liso-cel) to its pipeline through the $74 billion acquisition of Celgene. In May, the action date of the Biologics License Application (BLA) for the chimeric antigen receptor (CAR) T-cell therapy was extended by three months by the US Food and Drug Administration…

Automation: ‘The only way to truly scale cell therapy manufacture’ says Lonza

Lonza says it has achieved a significant milestone with partner Sheba Medical treating its first patient with a CD19 CAR-T cell immunotherapy made using the automated point-of-care Cocoon technology. In March 2019, Swiss CDMO Lonza entered a partnership with Israel’s Sheba Medical Center to provide automated and closed CAR-T manufacturing using its point-of-care (POC) Cocoon cell therapy manufacturing platform. This week, Sheba and Lonza announced the first patient has been dosed with a CD19 CAR-T cell immunotherapy made using the…

Thermo-stability could give DNA vaccine advantage in COVID-19 race, says Inovio

Inovio says the long shelf life and tolerance to heat of its DNA vaccine candidate could set it apart from the mRNA, protein, and viral-based COVID-19 vaccines in development. Inovio’s COVID-19 vaccine INO-4800 is composed of synthetic, circular DNA plasmids that encode parts of the viral protein. The candidate is in Phase I trials but Inovio is looking to initiate Phase 2/3 studies later this month, subject to US Food and Drug Administration (FDA) clearance. While the candidate has been…

Mesoblast talks Ryoncil, COVID-19 and manufacturing capacity

Mesoblast has sufficient capacity to launch Ryoncil for GVHD but will need to scale-up if the cell therapy works against COVID-19. The Australian firm outlined its manufacturing plan for Ryoncil and other candidates last week during its Q4 call. Ryoncil (remestemcel-L) is a candidate cell therapy for children with steroid-refractory acute graft versus host disease (SR-aGVHD). The product recently received the green light from the US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC), which recommended it be approved…