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With new partnership, Galapagos takes decentralized CAR-T manufacturing quest nationwide

May 17, 2024
Life sciences

Though Galapagos has undergone plenty of staff shake-ups and strategy revamps in recent years, the company is sticking strong to the CAR-T pivot first unveiled by CEO Paul Stoffels, M.D., following his arrival at the biotech from Johnson & Johnson in early 2022.

Now, the Belgium-based company is teaming up with the largest blood supply network in the U.S. to help realize its decentralized production ambitions for CAR-T therapies on a national scale.

Late Wednesday, Galapagos unveiled a new pact with Blood Centers of America (BCA), gaining access to the collection and donation network’s 50-plus community blood centers across 43 states to assist with manufacturing of Galapagos’ clinical CAR-T programs in hematology/oncology.

For its decentralized manufacturing approach, Galapagos works with external partners to utilize Lonza’s Cocoon manufacturing modules in geographically advantageous locations. The process features “a proprietary quality control testing and release strategy,” according to Galapagos.

In addition to helping Galapagos establish production of blood cancer candidates near cancer treatment centers, the collaboration will also see BCA provide apheresis capacity from its sites “when required,” Galapagos said.

Apheresis—the initial step in CAR-T manufacturing—is the process by which a patient’s own T cells are extracted before being altered and eventually infused back into the patient.

Apheresis capacity represents one of the “main bottlenecks” for the CAR-T treatment approach, Robert Hughes, Galapagos’ global head of technical operations, said in an interview, adding that the BCA deal diverges from the company’s previous team-ups with academic hospitals and contract manufacturers by expanding the reach of its production network throughout the U.S.

Galapagos is hoping its decentralized CAR-T manufacturing network can circumvent many of the pitfalls that have historically held back the promising class of advanced therapies. The company is touting the potential of its platform to help cut vein-to-vein time—the duration between cell collection and final infusion—to just seven days.

Many commercial cell therapy players currently struggle with building capacity and delivering cells in a reliable and consistent time frame, Thad Huston, Galapagos’ chief financial officer and chief operating officer, said during the interview.

What sets Galapagos’ approach apart from its peers’, according to Huston, is the fact that the company is working with fresh, rather than frozen cells, thanks to its point-of-care production model.

Galapagos’ deal with BCA comes on the heels of the company’s other CAR-T production collaborations with the likes of Landmark Bio and Thermo Fisher Scientific, which have signed on to help make the biotech’s prospective therapies at sites in the Boston and San Francisco areas, respectively.

Looking ahead, Galapagos will continue to look for partnership opportunities to expand its decentralized manufacturing network, Huston said, noting that the company hopes to eventually secure more partnerships at sites in Europe, Asia, Latin America and the Middle East.

“We do believe that external innovation is really how we’re going to advance care for patients with cancer,” the executive added.

Galapagos, which is also a small-molecule company, started its cell therapy journey shortly after the arrival of Stoffels as CEO in 2022 when it acquired CAR-T platform developer CellPoint and human antibody library owner AboundBio for upfront payments of $135.1 million and $14 million, respectively.

The company is currently testing three CAR-T candidates in the clinic in non-Hodgkin lymphoma, chronic lymphocytic leukemia and multiple myeloma.

Earlier this year, Galapagos decided to halt work an another CAR-T program aimed at refractory systemic lupus erythematosus. Simultaneously, the company disclosed 100 layoffs in a bid to “streamline” operations.

On the commercial front, Galapagos last fall inked a $53 million deal to unload its European and U.K. businesses for its JAK inhibitor Jyseleca (filgotinib) to Italy’s Alfasigma. As part of the transaction, which closed in January, Galapagos transferred roughly 400 employees involved with Jyseleca over to Alfasigma.

By Fraiser Kansteiner

Source: fiercepharma.com

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