Thousand Oaks-based Atara Biotherapeutics Inc. on July 15 announced that its lead immunotherapy drug candidate, called tabelecleucel (tab-cel for short), has been granted priority review by the U.S. Food and Drug Administration, with a target decision date of next Jan. 15.
This announcement triggered an immediate $20 million milestone payment under a previously announced licensing agreement with Paris-based pharma giant Pierre Fabre Laboratories.
If the FDA approves the drug next January, Atara is in line to receive an additional $60 million milestone payment from Pierre Fabre Laboratories.
Atara has applied to use its drug tab-cel as a monotherapy late-line option for Epstein-Barr virus-positive post-transplant lymphoproliferative disease. This refers to runaway lymphocyte production that can occur after organ transplants and trigger a range of diseases and disorders. The Epstein-Barr virus is very common and contagious, spreading through saliva and other body fluids; it can lead to a wide range of illnesses.
Traditionally, this combination of lymphoproliferative disease (PTLD) and Epstein-Barr virus (EBV) has been treated with chemotherapy. But if chemotherapy doesn’t work or is deemed inappropriate, there has been no FDA-approved treatment.
The tab-cel drug takes an immunotherapy approach, using an Epstein-Barr virus immune cell platform to target and eliminate Epstein-Barr virus-positive cells.
“The FDA’s granting of priority review highlights the high unmet need in EBV+ PTLD, which is a devastating disease with limited treatment options and a poor overall survival rate,” Pascal Touchon, Atara’s chief executive, said in the company’s announcement.
The FDA had previously granted the drug both breakthrough therapy and orphan drug designations, making it eligible for fast-track review and incentives to help with the drug development and clinical trial process.
To help develop and market the drug, Atara inked a licensing deal in late 2021 with Pierre Fabre Laboratories; that deal was expanded last December.
The drug has already been cleared for marketing to treat Epstein-Barr infected cells in patients in several European countries.
The expedited review process for tab-cel is welcome news for Atara investors, who were slammed with a 57% share price plunge in November after news that another of its immunotherapy drugs had failed to achieve statistically significant progress in treating multiple sclerosis patients. Atara then decided to scale back its development of this drug in favor of its other drug programs, including tab-cel.
