Atara Biotherapeutics Announces Further Layoffs Despite FDA Lifting Clinical Hold

Atara Biotherapeutics, a biopharma company focused on T-cell immunotherapies, has announced another round of layoffs affecting 30% of its remaining workforce. This decision comes just days after the U.S. Food and Drug Administration (FDA) lifted a clinical hold on the company's lead product, Ebvallo.

Continued Workforce Reductions

The latest round of layoffs will reduce Atara's headcount to just 23 employees, deemed "essential to executing on the company's strategic priorities." This move follows a series of workforce reductions over the past few years:

• In March 2023, Atara cut 50% of its staff following an FDA clinical hold on Ebvallo and a CAR-T candidate.
• In 2022, the company reduced its workforce by 20%.
• In 2021, Atara implemented a 25% reduction in staff as it shifted focus from a failed multiple sclerosis cell therapy to CAR-T prospects.

The most recent layoffs are expected to be completed by August 2023, with an estimated cost of $1.4 million in severance and related benefits.

FDA Lifts Clinical Hold on Ebvallo

Despite the workforce reductions, Atara received positive news last week when the FDA lifted the clinical hold on Ebvallo, an allogeneic T-cell immunotherapy. The hold, which was related to an FDA inspection of a third-party manufacturing facility, had been in place since earlier this year.

With the hold now lifted, Atara can resume its clinical trials, including:

1. The phase 3 Allele study of Ebvallo for patients with Epstein-Barr virus-associated post-transplant lymphoproliferative disease.
2. A phase 2 label-expansion multicohort clinical study.

Dr. Cokey Nguyen, CEO of Atara, stated that the company is "working closely with our partner Pierre Fabre Laboratories and our clinical trial sites and anticipate resuming enrollment and treatment of patients as soon as possible."

Strategic Shifts and Pipeline Changes

The recent clinical hold and subsequent lifting have led to significant changes in Atara's pipeline and strategy:

• The company has ended work on ATA3219, an allogeneic CD19-targeted CAR-T candidate for non-Hodgkin lymphoma and systemic lupus erythematosus.
• Another CAR-T therapy, ATA3431, has also been discontinued.
• Atara is now focusing its resources on advancing Ebvallo, which has already received approval in Europe.

These strategic decisions reflect the company's efforts to streamline operations and prioritize its most promising assets in the face of ongoing financial and regulatory challenges.