Calithera Announces Enrollment of First Patient in CB-839 in Combination with Checkpoint Modulator

SOUTH SAN FRANCISCO, Calif., Aug. 04, 2016 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, today announced that the first patient has been enrolled in a Phase 1/2 clinical trial assessing the safety and efficacy of CB-839, a first-in-class glutaminase inhibitor, in combination with nivolumab for the treatment of renal cell carcinoma, malignant melanoma and non-small cell lung cancer.

“In preclinical models, glutaminase inhibition with CB-839 substantially increased the number of tumor regressions in combination with  PD-1 and PD-L1 antibodies by overcoming a metabolic checkpoint blocking T-cell activation,” said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. “We have demonstrated that CB-839 can safely be added to standard of care therapeutics to treat solid tumors with the potential to improve clinical outcomes, and we look forward to the results of this trial testing an immuno-oncology therapy in combination with our first-in-class glutaminase inhibitor.”

The Phase 1/2 study will assess the safety, pharmacokinetics and pharmacodynamics of CB-839 and nivolumab.  The study will enroll patients with clear cell renal cell carcinoma who are either naïve to checkpoint inhibitors, or were recently treated with nivolumab without tumor response, as well as melanoma and non-small cell lung cancer patients who have received anti-PD-1 monotherapy as their most recent line of therapy without tumor response.

About Calithera Biosciences

Calithera Biosciences, Inc. is a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer.  Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase.  CB-839 takes advantage of the pronounced dependency many cancers have on the nutrient glutamine for growth and survival.  It is currently being evaluated in Phase 1/2 clinical trials in combination with standard of care agents.  CB-1158 is a first-in-class immuno-oncology metabolic checkpoint inhibitor targeting arginase, a critical immunosuppressive enzyme responsible for T‑cell suppression by myeloid-derived suppressor cells.  Arginase depletes arginine, a nutrient that is critical for the activation, growth and survival of the body’s cancer-fighting immune cells, known as cytotoxic T-cells.  Calithera is headquartered in South San Francisco, California.  For more information about Calithera, please visitwww.calithera.com.

 

Around the web

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

With generative AI coming into its own, AI regulators must avoid relying too much on principles of risk management—and not enough on those of uncertainty management.

Trimed Popup
Trimed Popup