Thousand Oaks-based immunotherapy company Atara Biotherapeutics Inc., which is attempting to develop drugs from a T-cell platform to treat patients with cancer and autoimmune diseases, suffered a major setback in January when the U.S. Food and Drug Administration rejected its Ebvallo drug due primarily to third-party manufacturing issues.
At the time, the FDA also suspended Atara’s clinical trial activity for Ebvallo and other drugs in its platform. The news sent Atara’s stock immediately plummeting by 50%, and within days, the company laid off half of its employees as it began transferring its drug development program to its partner, France-based pharmaceutical Pierre Fabre Laboratories.
Last month, Atara resubmitted its application for Ebvallo to the FDA, and last week the company announced that the agency has indicated that a decision on that application would come in early January.
“We look forward to continued engagement with the FDA throughout its review and with Pierre Fabre Laboratories as they actively prepare for the potential launch of this innovative therapy in the U.S.,” said Cokey Nguyen, Atara’s chief executive.
Atara’s immunotherapy platform uses T-cells to target the Epstein-Barr virus. The company cites research showing the virus plays a key role in the development of diseases such as multiple sclerosis and certain types of lymphomas.
Under a 2021 agreement with Pierre Fabre Laboratories, Atara would proceed with the FDA approval process, while Pierre Fabre would market the drug in the U.S. should it gain FDA approval. But then came the January debacle, with the FDA flagging the starting materials used in the making of the drug. Atara worked with the unnamed manufacturer to address the FDA’s concerns.
In its earnings release last week, Atara said it’s resuming its examination of strategic options for the company that were halted in April to address the reapplication. Those options could include “an acquisition, merger, reverse merger, other business combinations, licensing, sale of assets, or other strategic transactions.”
Atara gave no indication when – or even if – it would resume hiring. According to website WARNTracker.com, Atara has shed roughly 237 employees since January 2022, representing more than 90% of its workforce.
