A week after the US Food and Drug Administration (FDA) placed a clinical hold on two of Atara Biotherapeutics’ T-cell therapies. The company has announced a workforce reduction plan, laying off about 50% of its employees.
The news follows a harrowing month for Atara. On 16 January, the US FDA refused to approve its T-cell therapy Ebvallo (tabelecleucel), which Atara is developing with Pierre Fabre Laboratories. The agency issued a complete response letter (CRL) citing GMP compliance issues with the third-party manufacturing facility.
Ebvallo is an off-the-shelf, allogeneic T-cell immunotherapy, which has been approved as monotherapy by the European Commission (EC) for treating patients ages two years and above with Epstein‑Barr virus-positive post‑transplant lymphoproliferative disease (EBV+ PTLD).
The following week, the US FDA placed a clinical hold on the company’s investigational new drug applications for Ebvallo and another allogenic CD19 chimeric antigen receptor (CAR) T-cell pipeline candidate, ATA3219, citing the same manufacturing issues.
Atara stood to receive “a $60 million milestone payment from Pierre Fabre upon FDA approval of the Ebvallo”, along with “significant double-digit” tiered royalties as a percentage of net sales.
According to a 27 January SEC filing, the workforce reduction plan is expected to affect about 50% of its current employees and cost about $7.5 million in severance and other costs. Atara closed 2024 with approximately $43 million in cash reserves.
Atara had previously reported that it exploring strategic alternatives. Adding, if no resolution is reached to provide funding for its chimeric antigen receptor (CAR) T-cell therapies by the first quarter of 2025, Atara intends to “suspend all CAR-T activities, and significantly reduce company expenses and activities to only those that support the approval of Ebvallo”.
The company has also entered into a non-binding term sheet with Redmile Group for up to $15 million in equity line of credit funding, according to a 16 January press release. The company noted that the financing is “sufficient” to fund the ongoing activities required to achieve BLA approval.
