Friday, December 29, 2017

=Atara Biotherapeutics (ATRA) : phase 3 clinical studies to evaluate Tabelecleucel


  • Headquarters: South San Francisco, CA
  • Founded: 2012
  • atarabio.com



Atara Biotherapeutics announces FDA clearance to initiate two phase 3 clinical studies to evaluate Tabelecleucel  
Atara's tabelecleucel Phase 3 program consists of two global, multicenter, open-label studies:
  • For the treatment of patients with EBV+PTLD following allogeneic hematopoietic cell transplant (HCT) after failure of rituximab (MATCH)
  • For patients with EBV+PTLD following solid organ transplant (SOT) after failure of rituximab or after failure of rituximab plus chemotherapy (ALLELE).
  • The Phase 3 studies are expected to open for enrollment in the U.S. imminently and will later expand to include sites in the EU, Canada and Australia.
  • Results from the first tabelecleucel Phase 3 study to reach the primary endpoint are expected to be announced in the first half of 2019
  • The primary endpoint of both the MATCH and ALLELE studies is the confirmed objective response rate (ORR), defined as the percent of patients achieving either a complete or partial response to tabelecleucel treatment confirmed after the initial tumor assessment showing a response 

Description

Atara Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on developing therapies for patients with severe and life-threatening diseases. The Company operates through the business of developing and commercializing therapeutics segment. The Company is focused on developing allogeneic or third-party derived antigen-specific T-cells. T-cells are a type of white blood cell. The Company's product candidate, ATA129, is a third-party derived Epstein-Barr virus CTL for the treatment of Epstein-Barr virus (EBV). ATA188 is in development for the treatment of multiple sclerosis. ATA520, which is a third-party donor derived WT1-CTL, targets cancers expressing the antigen Wilms Tumor 1 (WT1). ATA520 is in Phase I clinical trials. The Company's T-cell product candidate, ATA230, which is a third-party derived cytomegalovirus-CTL (CMV-CTL), is in Phase II clinical trials for refractory CMV.

Key stats and ratios

Q3 (Sep '17)2016
Net profit margin--
Operating margin--
EBITD margin--
Return on average assets-52.64%-26.85%
Return on average equity-58.41%-27.79%
Employees96

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