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Kidney Drug PINTA 745 Fails Proof-of-Concept Trial

Development program grinds to a halt

Atara Biotherapeutics, Inc., has announced the results from its phase II proof-of-concept clinical study of PINTA 745, a peptide–antibody combination that blocks growth factors in the transforming growth factor-beta (TGF-beta) pathway, for the treatment of protein energy wasting in patients with end-stage renal disease (ESRD). The study did not meet its primary endpoint, defined as the percent change from baseline in lean body mass, as measured by dual energy x-ray absorptiometry, at week 12 after weekly treatment with PINTA 745.

The treatment also failed to improve physical function, measures of glycemic control, and markers of inflammation.

As a consequence of these results, Atara Bio has suspended further development of PINTA 745. According to the company, direct costs for the drug’s development totaled approximately $10 million.

In a study published in the October issue of International Journal of Obesity, PINTA 745 was effective in treating type-2 diabetes in mice.

With PINTA 745 discontinued, Atara said it will focus its clinical efforts on its portfolio of clinical- stage oncology and immunotherapy product candidates, including its Epstein-Barr virus (EBV)-targeted cytotoxic T-lymphocyte (EBV-CTL), which received a breakthrough therapy designation in rituximab-refractory EBV-associated post-transplant lymphoproliferative disorders after allogeneic hematopoietic cell transplant. The therapeutic is being studied in two ongoing phase II trials for EBV malignancies.

Atara is also developing a cytomegalovirus (CMV)-targeted cytotoxic T-lymphocyte, which is in two phase II clinical trials for the treatment of refractory CMV infections that occur in patients who have received an allogeneic hematopoietic cell transplant.

Another therapy in development is a Wilms' tumor 1-targeted cytotoxic T-lymphocyte, which is in two ongoing phase I clinical trials assessing safety and initial anti-tumor efficacy in patients with hematologic malignancies.

And Atara is working on an activin inhibitor, STM 434, which is in an ongoing phase I trial assessing safety and initial anti-tumor efficacy in patients with ovarian cancer and other advanced solid tumors.

Sources: Atara Bio; December 14, 2015; and BioSpace; December 14, 2015.

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