The allogeneic T-cell immunotherapy company is now approaching penny stock territory after its multiple sclerosis drug failed to reach the primary endpoint in a mid-stage study.
Pictured: Stocks trending down/iStock, lerbank
Hit with a stock selloff, Atara Biotherapeutics is evaluating its next moves after a Phase II failure for its drug to treat non-active progressive multiple sclerosis.
The California-based biotech announced on Wednesday that its mid-stage EMBOLD study investigating its T-cell immunotherapy ATA188 did not reach the primary endpoint of confirmed disability improvement by using the expanded disability status scale (EDSS) at 12 months. Other biomarkers for fluid and imaging also did not give the trial any more supporting evidence. No further details on the data were immediately available.
Atara’s stock price saw a 57% reduction Thursday morning on the news.
“We are surprised and deeply disappointed with the results of EMBOLD, particularly for the MS patient community which is in urgent need of new treatment options. We are grateful to the patients and investigators who participated in the study, and to colleagues at Atara for their steadfast work,” Atara CEO Pascal Touchon said in a statement.
According to Atara, the biotech plans to “significantly reduce its expenses” on the candidate and will aim to direct its resources on its allogenic CAR-T pipeline. The company said that it will review the data for ATA188, including its Phase I data, and figure out the next steps for the program later. Still, Touchon said that the biotech anticipates halting the study as “no treatment benefit was observed.”
The allogeneic T-cell immunotherapy company’s ATA188 journey started with the Phase I/II EMBOLD clinical trial in 2017 to determine the safety and the correct dosage. According to Multiple Sclerosis News Today, Phase I had nine of 24 patients showing disability improvement.
Atara’s CAR-T pipeline is currently in the early stages of development and has candidates geared toward treating B-cell malignancies and solid tumors. Earlier this month, the company announced in its third-quarter earnings report that it plans to expand the immunotherapy tabelecleucel (tab-cel) partnership with Pierre Fabre through a BLA transfer.
Atara received $30 million upfront, with around $100 million available to the company if regulatory milestones are hit. The biotech claims these moves will extend its cash runway past the third quarter of 2025.
“Looking ahead, we maintain our strong conviction in the potential of our pipeline reinforced by the first ever regulatory approval of an allogeneic T-cell immunotherapy, Ebvallo, in Europe,” Touchon said
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
