Atara Biotherapeutics ( ATRA Quick Quote ATRA - Free Report) is a biotech company focused on developing off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions.
The company utilizes its proprietary technology platform to develop novel therapies that target Epstein-Barr virus (EBV)-driven diseases.
The most advanced T-cell immunotherapy program in Atara’s pipeline is tabelecleucel (tab-cel). It is currently being evaluated in a phase III study in the United States for EBV-associated post-transplant lymphoproliferative disease (EBV+ PTLD). The therapy received approval in Europe last year for EBV+ PTLD indication. It is being marketed with the trade name Ebvallo by Pierre Fabre Medicament under an exclusive commercialization and license agreement.
Since the past month, shares of Atara have plunged 56.7% against the
industry’s breakeven growth. Image Source: Zacks Investment Research
The downside was due to the failure of the phase II EMBOLD study evaluating ATA188 in non-active progressive multiple sclerosis (PMS). The study failed to meet its primary endpoint of confirmed disability improvement (CDI) following 12 months of treatment with the therapy. Data from the study showed that treatment with ATA188 led to a 6% disability improvement compared with a 16% improvement in the placebo group.
The reported figures raise questions about the clinical efficacy of ATA188. Data from a previously reported phase I study showed that patients treated with the therapy had achieved 33% disability improvement. Also, Atara had estimated improvement rates in the placebo group of the EMBOLD study to lie in the range of 4-6%. Management is actively reviewing these results to understand the disparity in data.
Though management intends to use the understanding from the review to determine the program’s future, it has already decided to reduce expenses on ATA188 and focus the company’s resources on advancing its allogenic CAR-T pipeline. As a result of this decision and its recent partnership expansion with Pierre Fabre, Atara expects its cash runway to extend beyond third-quarter 2025.
Earlier this month, Atara expanded its partnership with Pierre Fabre to exclusively commercialize tab-cel in the United States and the remaining global commercial markets. In exchange, Atara is eligible to receive up to $640 million (including $30 million as an upfront cash payment) and significant double-digit tiered royalty on net sales.
Atara had previously shared an interim update on the EMBOLD study in July last year, which showed that the dataset was not sufficient to “draw conclusions” and that it would continue the study until the primary analysis of the primary endpoint at 12 months.
Currently, Atara’s pipeline consists mainly of next-generation CAR-T and allogenic CAR-T cell (AlloCAR T) therapies. Over the coming year, Atara intends to present preclinical data on its CD19-CD20 CAR-T candidate ATA3431 and preliminary phase 1 data on its CD19 CAR-T ATA3219 in lymphoma patients. Management also wants to start clinical studies on ATA3219 in autoimmune diseases.
Zacks Rank & Stocks to Consider
Atara currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include
Acadia Pharmaceuticals ( ACAD Quick Quote ACAD - Free Report) , Allogene Therapeutics ( ALLO Quick Quote ALLO - Free Report) and AnaptysBio ( ANAB Quick Quote ANAB - Free Report) , all carrying a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
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