Atara’s allogeneic T-cell therapy flunks multiple sclerosis study
09 Nov 2023
Clinical ResultPhase 1Phase 2Cell TherapyImmunotherapy
Atara Biotherapeutics will scale back investment in ATA188 after the investigational off-the-shelf, allogeneic T-cell immunotherapy failed to meet the primary endpoint of a Phase II study in non-active progressive multiple sclerosis. "We are surprised and deeply disappointed with the results,” remarked CEO Pascal Touchon, which sent the company’s shares down as much as 45%.
The EMBOLD trial included 103 adults with progressive multiple sclerosis who received two cycles of treatment with ATA188 or placebo and followed for 12 months. The study’s main goal was confirmed disability improvement (CDI) by expanded disability status scale (EDSS) at 12 months.
According to Atara, ATA188 was associated with a 6% disability improvement in EMBOLD, while the improvement for placebo was 16%. The company noted that it is reviewing the data, given the “substantially greater than expected” result for placebo and a 33% disability improvement seen in an earlier Phase I study of ATA188. “We are further evaluating the EMBOLD data…however we anticipate stopping the study as no treatment benefit was observed,” Touchon added.
Atara said that it will significantly reduce its expenses on ATA188 and instead focus resources on advancing its allogeneic CAR-T pipeline. Earlier this month, the company announced an expanded partnership with Pierre Fabre Laboratories for tabelecleucel (tab-cel), which is under investigation for Epstein-Barr virus-associated post-transplant lymphoproliferative disease.
At the time of disclosing the Pierre Fabre deal, Atara indicated that it will cut its workforce by around 30% as part of a strategic restructuring. “Following anticipated additional payments and significant double-digit royalties from the recently expanded tab-cel partnership with Pierre Fabre, we are currently well positioned with a cash runway well beyond upcoming milestones,” Touchon said.
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