Under the agreement, which is due to close in December 2023, Pierre Fabre will take over the manufacturing, clinical, and regulatory activities related to tab-cel in the U.S, Canada and other geographies. Atara expects to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the treatment in the second quarter of 2024.
In return, Atara is due to receive up to $640 million, with near-term payments including $30 million upfront and up to $100 million in potential milestone payments as the therapy advances through the regulatory process. Pierre Fabre will also reimburse Atara for costs associated with the development of tab-cel up to applying for approval from the US Food and Drug Administration (FDA) and buy up current and future tab-cel inventory. Atara can also expect double-digit tiered royalties on net sales.
Atara joined forces with Pierre Fabre in October 2021 to co-develop tab-cel for the treatment of the blood cancer Epstein‑Barr virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD). The agreement originally covered Europe, the Middle East, Africa and other emerging markets and Pierre Fabre bagged market approval from the European Union in December 2022.
"Since Ebvallo’s marketing authorization in Europe less than a year ago, patients have already been treated in Germany, or have benefited from the treatment through the Early Access Program in place in other European countries" said Eric Ducournau, CEO of Pierre Fabre Laboratories, in a public statement. "We are now eager to progress on the upcoming FDA milestones in the next months and ensure American patients diagnosed with EBV+ PTLD can access this novel therapy."
Branded as Ebvallo, the therapy is the first approved allogeneic t-cell immunotherapy in addition to the first approved treatment for EBV+ PTLD, which often occurs in transplant patients given immunosuppressive drugs to prevent rejection of the transplanted organ. Unlike traditional CAR-T therapies, tab-cel does not involve genetic modification and instead involves training donor T cells to hunt down cells infected with EBV, which is linked to many conditions.
The partnership extension is intended to help Atara to extend its cash runway to the third quarter of 2025. With $102.4 million in the bank as of September 2023, Atara plans to shuffle its pipeline and cut its workforce by approximately 30 percent.
Meanwhile, the company plans to focus its efforts on allogeneic cell therapy candidate ATA188 for the treatment of progressive forms of multiple sclerosis (MS). Atara is also pushing forward CAR-T programs based on its EBV-seeking T cell therapies with a phase 1 study in relapsed/refractory B-cell non-Hodgkin’s lymphoma expected to start in the coming months.
