Regenerative Medicine and Stem Cells Technologies

Speed is of the essence when it comes to manufacturing CAR T drugs—personalized treatments in which immune cells are engineered to recognize and destroy patients’ cancers. With that in mind, Gilead will locate a new European manufacturing site for its CAR-T therapy Yescarta at an airport in the Netherlands.

Kite, the Gilead company that developed the personalized treatment, said today it has leased a 117,000 square-foot facility in Hoofddorp at the SEGRO Park Amsterdam Airport. It did not say how much it will invest in the manufacturing operation but indicated it expects to have 300 employees there when it is fully operational in 2020.

Yescarta was approved by the FDA last fall to treat adults with relapsed or refractory large B-cell lymphoma, including aggressive non-Hodgkin lymphoma, who have failed two or more traditional treatments. It is priced at $375,000 in the U.S. and is currently under review by regulators in Europe.

“This new European manufacturing facility will enable personalized cell therapies to be manufactured in closer geographic proximity to the patients who will receive them, potentially shortening the turnaround time for people who urgently need care,” Gilead CEO John Milligan said in a statement.

In addition to the Amsterdam site, Kite today said it recently acquired a new building in Santa Monica, California, from Astellas Pharma that it will use for clinical manufacturing and cell therapy R&D.

It also picked up a 26,000-square foot facility in Gaithersburg, Maryland, which it will use in support of a new agreement with National Cancer Institute (NCI). The plan is to develop adoptive cell therapies targeting patient-specific tumor neoantigens. Neoantigens are mutations found on the surface of cancer cells that are unique to each person and tumor, offering the potential for more targeted antitumor activity.

Gilead bought Kite for nearly $12 billion last year to move into the new field as sales of its hep C franchise lagged.

So far, only two CAR-T drugs have been approved in the U.S.—Yescarta’s FDA nod followed the approval in August 2017 of Novartis’ Kymriah. The Novartis treatment, priced at $475,000, was initially approved to treat pediatric patients with acute lymphoblastic leukemia.

Novartis is producing its CAR-T product at its global head cell & gene technical development and manufacturing site in Morris Plains, New Jersey. It also has an agreement with the Fraunhofer Institute for Cell Therapy and Immunology for the cell processing of its personalized T cell therapy in Europe.

Reference: https://www.fiercepharma.com/pharma/gilead-building-its-eu-car-t-manufacturing-amsterdam