The deal includes an exclusive long-term supply agreement for Catalent to support Erytech’s lead product candidate eryaspase (GRASP), a red blood cell-derived product, which is currently in late-stage development for the treatment of acute lymphoblastic leukemia and already produced at the site. Catalent will also support the development of Erytech’s pipeline of encapsulated red blood cell-based therapeutics for severe forms of cancer and orphan diseases.
Catalent says the acquisition of the site will help it grow its US footprint as the demand for cell therapies continues to grow.
Strategic campus in New Jersey
CDMO Catalent’s cell and gene therapy network in the US includes six facilities across Maryland and Texas.
The addition of the New Jersey site will create a ‘strategic campus’ focused on the development and clinical and commercial scale manufacturing of cell therapies.
It is located within easy reach of Catalent’s facilities around Baltimore, Maryland, where the company develops and manufactures viral vectors and plasmid DNA. It will also work in collaboration with Catalent’s existing clinical-scale cell therapy facility in Houston, Texas.
The 30,900-square-foot facility in New Jersey is located within the University Square Campus Park and houses 16 suites positioned for production of products in a cGMP-compliant manner, as well as laboratories for analytical, quality control and microbiology testing.
Catalent will also lease an adjacent 23,000-square-foot building that could be used for additional laboratory or cGMP capabilities, and another building on the campus for potential future expansions.
Around 40 staff currently work at the site: all of whom will be offered employment with Catalent.
“This acquisition is strategically important to Catalent’s commitment to support the development and clinical and commercial supply of cell therapies to meet rapidly growing demand,” said Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy.
“The talented and experienced staff already employed at the facility, the capabilities it has in place, and the opportunity to quickly add further capacity on the same site, allow Catalent to expand rapidly to create a US campus and center of excellence for cell therapy development and manufacturing that will serve customers around the world.”
Development focus for Erytech
Erytech is a clinical-stage biopharmaceutical company developing innovative red blood cell-based therapeutics for severe forms of cancer and orphan diseases.
It uses its Erycaps platform - which uses a novel technology to encapsulate drug substances inside red blood cells - to develop its pipeline of products.
Its lead product candidate, eryaspase (GRASPA), which consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cells’ altered asparagine and glutamine metabolism.
The proof of concept of eryaspase as a cancer metabolism agent was established in different trials in acute lymphoblastic leukemia (ALL) and pancreatic cancer. An investigator sponsored Phase 2 trial (IST) evaluating the use of eryaspase in ALL patients who developed hypersensitivity reactions to pegylated asparaginase recently reported positive results, based on which the company intends to request approval in the US and potentially other territories.
Erytech produces its product candidates for treatment of patients in Europe at its GMP-approved manufacturing site in Lyon, France. Gil Beyen, CEO at Erytech, said the new partnership will see Catalent cater for patients in the US and allow Erytech to focus on development of therapeutics.
“Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics, and we believe this win-win strategic partnership will meet our long-term manufacturing needs in the US," he said. "Erytech will now further focus its resources on seeking regulatory approval of GRASPA and on the development of potentially transformative therapeutics for serious diseases.”