Landmark Bio Signs Multi-Year Agreement to Manufacture Galapagos' Oncology CAR-T Cell Therapy Clinical Programs at the Point-of-Care

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Landmark Bio has signed a multi-year strategic manufacturing agreement with Galapagos NV to perform GMP manufacturing of clinical trial batches of Galapagos' CAR-T therapies in the Boston area. The agreement aims to implement Galapagos' decentralized CAR-T manufacturing model, which aims to address current limitations of CAR-T treatments. Landmark Bio's facility includes laboratory space, cleanrooms for cell therapies, and wraparound services.

Landmark Bio will serve as strategic point-of-care manufacturing partner for Galapagos' CAR-T product candidates in the Boston area

WATERTOWN, Mass., Nov. 6, 2023 /PRNewswire/ -- Landmark Bio, a collective endeavor bringing together leaders in industry, academia, and research hospitals to accelerate development and industrialization of next-generation genomic medicines, announced that it has signed a multi-year strategic manufacturing agreement with Galapagos NV (Euronext & NASDAQ: GLPG), an innovative biotech company with operations in Europe and the U.S.

Under the terms of the agreement, Landmark Bio will perform GMP manufacturing of clinical trial batches of Galapagos' development programs of chimeric antigen receptor (CAR) T-cell therapies in hematology-oncology in the Boston metropolitan area.

The manufacturing agreement aims at implementing Galapagos' novel decentralized CAR-T manufacturing model, designed to enable clinicians to administer CAR T-cells within a median of seven days of leukapheresis, thereby aiming to address important limitations of current CAR-T treatments.

"We are excited to partner with Galapagos to support their CAR-T clinical development programs in the U.S.," said Ran Zheng, CEO of Landmark Bio. "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."

Landmark Bio's 44,000 square-foot fully integrated development and manufacturing facility includes laboratory space for translational research and early development, process and analytical development, and technology innovation. The biomanufacturing area is comprised of nine cleanrooms for cell therapies, genome editing, viral vector, mRNA, and lipid nanoparticle production as well as fill and finish and in-house Quality Control (QC) testing. In addition, Landmark Bio provides wraparound services such as drug development and regulatory consulting, program management and other support services.

Financial terms of the agreement were not disclosed.

About Landmark Bio

Landmark Bio PBLLC, a statutory public benefit limited liability company, or PBLLC, is a collective endeavor launched by leaders from academia, the life sciences industry, and world-renowned research hospitals to accelerate the development and industrialization of novel therapeutics. Inspired by recent advancements in cell and gene therapy, Landmark Bio was established to remove barriers in drug development, create accessible capability, expertise, and solutions, and offer a collaboration platform to advance manufacturing technologies for the new generation of medicines to come. Founding partners include Harvard University, Massachusetts Institute of Technology (MIT), Cytiva, FUJIFILM Diosynth Biotechnologies (FDB), and Alexandria Real Estate Equities, Inc. Other collaborating institutions include Beth Israel Deaconess Medical Center, Boston Children's Hospital, Mass General Brigham, and the Dana- Farber Cancer Institute. For more information, visit http://landmarkbio.com.

About Galapagos

We are a global biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life. Focusing on high unmet medical needs, we synergize the most compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders. For additional information, please visit www.glpg.com or follow us on LinkedIn or X (formerly Twitter).

 

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SOURCE Landmark Bio

FAQ

What is the strategic manufacturing agreement between Landmark Bio and Galapagos?

The strategic manufacturing agreement between Landmark Bio and Galapagos involves Landmark Bio performing GMP manufacturing of clinical trial batches of Galapagos' CAR-T therapies in the Boston area.

What is Galapagos' decentralized CAR-T manufacturing model?

Galapagos' decentralized CAR-T manufacturing model aims to enable clinicians to administer CAR T-cells within a median of seven days of leukapheresis, addressing current limitations of CAR-T treatments.

What facilities does Landmark Bio have?

Landmark Bio's facility includes a 44,000 square-foot fully integrated development and manufacturing facility with laboratory space for translational research and early development, cleanrooms for cell therapies, and wraparound services.

What services does Landmark Bio provide?

In addition to manufacturing, Landmark Bio provides wraparound services such as drug development and regulatory consulting, program management, and other support services.