Under the terms of the agreement, Landmark Bio will be Galapagos’ manufacturing partner for CAR-T therapies in the Boston area, with the aim to provide the cell therapy to patients within a median of seven days after the therapy manufacturing begins. Financial details of the deal were not disclosed.
"This strategic manufacturing collaboration is a testament to our expertise in cell and gene therapy manufacturing and underscores our commitment to bring more life-saving therapies to patients faster," said Landmark Bio CEO, Ran Zheng, in a public statement.
CAR-T therapies are a type of cell therapy where the patient’s own immune cells are genetically engineered to hunt down cancer, with several in the market for the treatment of forms of blood cancer. The manufacturing of current CAR-T therapies involves the extraction of T cells from the patient, modification in a central manufacturing facility, and then delivery back into the patient – a process that is costly and can take months to complete.
Galapagos aims to develop a decentralized approach to manufacturing CAR-T therapies that doesn’t require the transport of cells to and from central facilities, which could cut costs and the time taken to produce the therapy. With the help of proprietary workflow management software and manufacturing technology developed by Lonza, the company aims to make the therapy available to more patients.
Landmark Bio was set up in 2021 as an initiative to accelerate the development of new therapies including cell and gene therapies. The organization hosts a 44,000 square-foot manufacturing facility complete with nine cleanrooms for the production of advanced therapies in addition to fill and finish and quality control services.
Galapagos originally specialized in the development of its lead immunology candidate filgotinib, which blocks the protein Janus kinase inhibitor (JAK). The candidate gained EU approval for the treatment of ulcerative colitis in 2021 and was branded as Jyseleca. However, the U.S. Food and Drug Administration (FDA) rejected the approval of filgotinib due to toxicity concerns.
Following further clinical setbacks with filgotinib, Galapagos added CAR-T therapies to its pipeline in 2022. In October 2023, Galapagos signed a letter of intent to transfer its Jyseleca business to Alfasigma with plans to cut around 100 positions across the company.