Atara Biopharmaceuticals (ATRA) Shares Off Sharply after PEW Drug Fails Phase 2 Study

Shares of Atara Biopharmaceuticals Inc. (ATRA) were trading down -13.20 or -39.76 percent to $20.00 per share in this morning’s premarket after the company announced early this morning that its product candidate for the treatment of protein energy wasting or PEW had failed a Phase 2 clinical trial. Atara Bio stock closed at $33.20 per share, down -0.31 or -0.93 percent in Friday’s regular trading session.

Founded in 2012, Brisbane, California based Atara Biopharmaceuticals Inc. was started by Isaac Ciechanover M.D. and is named after cancer patient Atara Ciechanover, who died after her fight with cancer in 2012.
The company was spun off of Amgen (AMGN) and had its Initial Public Offering in December of 2013. The company develops therapies for patients with unmet medical needs in diseases which have had limited innovation for treatments with a focus on oncology and immunotherapy. The company’s products include molecularly targeted and T-cell product candidates which target activin and miostatin, two proteins from the TGF beta family of proteins.

This morning, Atara Bio announced that its PINTA 745 treatment for protein energy wasting or PEW in patients with end stage renal disease or ESRD did not meet its primary endpoint in a Phase 2 proof of concept clinical trial. The primary endpoint for the study was defined by the percent change in Lean Body Mass at the end of the 12 week trial period after weekly treatments of PINTA 745.

In addition, PINTA 745 did not improve markers of inflammation, glycemic control or physical function with any adverse effects observed in patients during the trial. Due to the failure, Atara Bio will suspend any further development of the treatment. According to the company’s press release, third party direct costs of the program came to approximately $10 million from its inception through the third quarter of 2015.

Isaac Ciechanover, M.D. President and Chief Executive Officer of Atara Bio stated in the company’s press release that, “We are very disappointed that PINTA 745 did not meet the primary endpoint of this Phase 2 clinical trial. These data are unambiguous and contrast with prior clinical and preclinical results. We want to sincerely thank the patients and investigators for their participation in this trial.”

Atara said that they would use cash on hand for the development of its T-cell therapies targeting cancer. The company said it had $334.3 million in cash and equivalents, which was enough for the company to develop the medications in its pipeline.

The treatments the company will now focus on include, Epstein-Barr Virus (EBV) Targeted Cytotoxic T-Lymphocyte (EBV-CTL), which is currently in two Phase 2 trials for EBV malignancies; Cytomegalovirus (CMV) Targeted Cytotoxic T-Lymphocytes (CMV-CTL), currently in two Phase 2 clinical trials for refractory CMV infections; STM 434, currently in an ongoing Phase 1 trial, is an activin inhibitor for patients with ovarian cancer and other advanced solid tumors; and Wilms' Tumor 1 Targeted Cytotoxic T-Lymphocytes (WT1-CTL), currently in an ongoing Phase 1 trial, which assesses safety and anti tumor efficacy in patients with hematological malignancies.

Atara stock is down significantly before the bell, shares are now trading below $20. The stock could test its yearly low of $17.20 if the market opens considerably lower this morning.

Other News About ATRA

Atara Bio Announces Positive Results From a Phase 2 Clinical Trial of Cytomegalovirus Targeted Cytotoxic T Lymphocytes (CMV-CTL)

New treatment for patients with refractory CMV disease in the central nervous system.

Atara Bio Announces Positive Results From Phase 1 Clinical Trial of Wilms’ Tumor 1 Targeted Cytotoxic T Lymphocytes (WT1-CTL) Product Candidate in Hematologic Malignancies

Findings were reported at the American Society of Hematology’s annual meeting.
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Published on Dec 14, 2015
By Jay Hawk
Jay Hawk
Jay Hawk enjoyed a 12-year professional financial markets career incorporating extensive first hand futures and options experience obtained by trading in the stock, commodity and forex markets on U.S. exchanges. Since retiring as a full-time financial market professional, he has been actively trading stock, commodities, forex and options for his own account and managing funds for others, as well as writing financial market commentary and educational articles.

Copyrighted 2016. Content published with author's permission.

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