Atara Biotherapeutics Wins FDA Clearance for Late-Stage Trials

Atara Biotherapeutics Inc. (NASDAQ: ATRA) shares surged on Friday after the firm announced that it received clearance from the U.S. Food and Drug Administration (FDA) to initiate two Phase 3 clinical studies. Specifically these mid-stage studies deal with tabelecleucel in patients with rituximab-refractory Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+PTLD).

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Atara intends to initiate these studies imminently. Tabelecleucel is Atara’s off-the-shelf T-cell immunotherapy in development for the treatment of EBV+PTLD, as well as other EBV associated hematologic and solid tumors.

The Phase 3 studies are expected to open for enrollment in the United States imminently and will later expand to include sites in the European Union, Canada and Australia.

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Looking ahead, results from the first tabelecleucel Phase 3 study to reach the primary endpoint are expected to be announced in the first half of 2019. Atara also plans to submit a tabelecleucel Conditional Marketing Authorization (CMA) application in the EU for patients with rituximab-refractory EBV+PTLD following HCT during the first half of 2019.

Isaac Ciechanover M.D., CEO and president of Atara, commented:

We are delighted to have received FDA clearance to start the tabelecleucel Phase 3 clinical studies. This achievement included extensive collaboration with the FDA under Breakthrough Therapy Designation and we expect tabelecleucel to be the first off-the-shelf T-cell immunotherapy to begin Phase 3 clinical development in the U.S.  Receiving clearance to initiate these studies is a significant milestone for Atara, and we expect to open our initial clinical sites imminently to serve the substantial unmet need for patients with this life-threatening condition.

Shares of Atara were last seen up about 25% at $19.10, with a consensus analyst price target of $28.00 and a 52-week range of $11.80 to $23.00.

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