Atara Biotherapeutics has been working for years to advance its allogeneic T cell therapy platform for patients with cancer and autoimmune diseases, with a focus on the ever delicate task of manufacturing such a therapy. On Wednesday, the company announced an agreement to divest its California manufacturing site to Fujifilm Diosynth in exchange for an upfront payment of $100 million and a long-term license agreement.
Fujifilm will give Atara access to the flexible capacity and specific capabilities needed to manufacture clinical and commercial-stage allogeneic cell therapies. This includes tab-cel, an experimental allogeneic off-the-shelf therapy for the treatment of Epstein-Barr virus-induced post-transplant lymphoproliferative disease. Currently, there are no approved treatments available for the disease, which is a virus that can affect patients after solid organ or allogeneic hematopoietic cell transplantation.
In exchange, the CDMO giant obtains 140 qualified employees at the Thousand Oaks site. It’s a deal that made sense, in large part, because allogeneic therapies don’t require the need for full capacity all the time or the ability to scale rapidly at all times, the CEO said. Atara, Pascal Touchon, in an interview with Terminal news. When the company first built the facility, controlling the entire facility was a key objective. But what they discovered after successfully increasing the number of doses per batch is that the company doesn’t need full capacity all the time, especially internally. And since Atara developed the process, it can easily transfer the process to anyone.
“It’s completely off-the-shelf, which means we have an inventory of products, like a monoclonal antibody,” he said. “When we get a specific request from a patient…we just need to find the right product for the right patient in our inventory, and we do that in three days.”
Epstein-Barr is the virus that causes mononucleosis. Atara has submitted Phase III trial data to the EU for regulatory review and expects to submit data to the FDA for a BLA by the second quarter of this year. Its pipeline also includes ATA188 for multiple sclerosis and CAR T-cell therapies ATA3271 and ATA3219.
Eleven of 19 responders in the Phase III ALLELE trial saw duration of response greater than six months, Atara said. Of the remaining eight responders, four patients experienced disease progression or died, and four were not evaluable for a six-month response at the time of the data cut. There were no treatment-related deaths, according to CMO AJ Joshi. The overall response rate, which was the primary endpoint of the study, was 50% in 38 patients with EBV PTLD with relapsed or refractory responses to rituximab and chemotherapy were treated.
The site has 90,000 square feet to support clinical and commercial operations, and it can also expand to support other products. The acquisition also helps Fujifilm expand its presence in the United States, CEO Martin Meeson said in a statement. Just in the fall, the company inaugurated a new headquarters in North Carolina, a project whose cost is estimated at 2 billion dollars.
“This deal, we think is probably the way to go,” Touchon said. “I strongly believe that the future of allogeneic cell therapy will be as it was for monoclonal antibodies 20 to 30 years ago. When you control the manufacturing process, the more you can leverage other companies, the more you increase your manufacturing productivity.