Galapagos, in makeover mode, strikes deal to make CAR-T therapies at blood centers across U.S.
Andrew Joseph
By Andrew Joseph May 15, 2024
STAT
Seeking to differentiate itself from other makers of CAR-T cancer therapies, Galapagos NV on Wednesday announced it had struck a deal with Blood Centers of America to open up dozens of manufacturing sites for its cell-based medicines around the U.S.
Galapagos said it will rely on the partnership, the financial terms of which were not disclosed, as it moves its CAR-Ts for different cancers into pivotal studies and could also help launch those medicines should they win approval. The Belgian company framed the collaboration as one that could help overcome the limitations that have held back access to existing CAR-T therapies from other companies.
CAR-Ts have proven to be potent treatments for certain cancers, but they are complicated medicines to make. Immune cells have to be removed from a patient, shipped to specialty sites, where they’re engineered with cancer-killing abilities, and then returned to the hospital for infusion back into patients. The process, which can take weeks if not months, has put a crunch on the number of patients companies and hospitals are able to treat.
Other companies are far ahead of Galapagos in the CAR-T field, with products on the market from the likes of Gilead, Bristol Myers Squibb, and Johnson & Johnson. But Galapagos has had a possible ace up its sleeve — a point-of-care technology that could shrink the whole manufacturing process down to seven days. If the company can reduce what’s known as the “vein to vein” time to a week, it could help Galapagos’ medicine compete.
The company already has regional manufacturing agreements in place with Thermo Fisher Scientific and Landmark Bio in different parts of the U.S. But with the new deal, Galapagos will be able to deploy its platform at dozens of sites in BCA’s national network of blood centers. In a way, it’s turning its manufacturing selling point into reality.
“You need to be near the patients,” Thad Huston, Galapagos’ chief financial officer, told STAT. With cell therapies, he said, “you have to be able to deliver it within hours or within a day.”
Galapagos, which also has a pipeline of immunology drugs, has bet on CAR-T therapies to help remake itself. As a STAT story documented last year, the company’s collapse had made it, in the view of Wall Street, the worst investment in biotech. And yet it had also become a point of fascination and potential promise in the industry, particularly with Paul Stoffels, a veteran drug hunter, taking over as CEO in 2022.
Investors then will be watching closely to see if the company’s manufacturing strategy can work. Galapagos has CAR-Ts for non-Hodgkin lymphoma, chronic lymphocytic leukemia, and multiple myeloma in trials.
“Moving forward, investor focus will be entirely on Galapagos’ efforts to develop and augment its early pipeline,” TD Cowen analysts wrote in a note earlier this month, adding that initial studies of some of the company’s CAR-T products showed “promising early efficacy with clean safety” and validated its manufacturing approach.
Having the deal with the blood centers could also help Galapagos should its CAR-T treatments win approval. Instead of having to build up manufacturing at that point, the company will already be up and running and will be able to “rapidly deploy into the United States,” said Robert Hughes, the company’s global head of technical operations.