Landmark Bio to manufacture oncology CAR-T for Galapagos

Landmark Bio will manufacture clinical trial batches of Galapagos’ developmental chimeric antigen receptor (CAR-T) candidates in Boston, Massachusetts.

Under the terms of the agreement, academia-industry joint venture Landmark Bio will serve as Belgian biotech firm Galapagos’ manufacturing partner for CAR-T therapies targeting blood cancer. Production will take place at Landmark Bio’s 44,000 square-foot facility in Watertown, Massachusetts, which opened in October 2022.

 “Landmark Bio’s approach is first to understand that product and manufacturing processes are intrinsically connected for this complex modality,” Ran Zheng, CEO of Landmark Bio told BioProcess Insider.

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“We aim to produce CAR-T products with functionally closed manufacturing systems and apply automatics and other digital technologies in production, testing, and supply chain management where applicable. This approach helps ensure consistency, product quality, and improve manufacturing efficiency.”

Furthermore, the multi-year deal aims to get CAR-T therapies to patients faster than the timelines associated with using traditional methods. The agreement will implement Galapagos’ decentralized CAR-T manufacturing model, which has been designed to allow clinicians to administer CAR-T cells within seven days of leukapheresis.

“For autologous CAR-Ts, scalability and cost of manufacturing due to manual processing are among some of the biggest challenges,” said Zheng.

She continued: “this is where an automated manufacturing process using closed systems can help alleviate these constraints. Another challenge is the time required to make these patient-specific products and for some very sick patients they may not have the time to wait for the therapies. Shortening the manufacturing turnaround time, having point of care manufacturing for autologous CAR-Ts, or taking an allogeneic CAR-T approach would help address this challenge.”

Financial terms of the agreement were not disclosed, and Landmark Bio said it does not need to scale up staff or space to service this deal in the US.

Galapagos focused previously on small molecules. However, in June 2022, it entered the cell therapy space through the acquisitions of Cellpoint and AboundBio for €130 million and $14 million, respectively. A few months later, the firm announced a business restructure that included reducing its fibrosis and kidney disease programs and cutting 200 staff in favor of its immune-oncology pipeline.

Additionally, the company received a $3.95 billion upfront payment from CAR-T pioneer Gilead Sciences in 2019, along with a $1.1 billion equity investment, for access to Galapagos’ drug discovery platform and current and future pipeline outside of Europe.