Calithera Biosciences to Present New Data on Two Oncology Programs at ESMO Congress 2019

– Results from ENTRATA Phase 2 trial of telaglenastat in patients with advanced renal cell carcinoma (RCC) accepted as Late-Breaking Oral Presentation

 

– Data from INCB001158 clinical program accepted as Oral Presentation

 

SOUTH SAN FRANCISCO, Calif., Sept. 03, 2019 – Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, today announced that new data from two oncology programs have been selected for oral presentations at the European Society for Medical Oncology (ESMO) 2019 Congress to be held September 27-October 1, in Barcelona, Spain.

 

The late-breaking abstract (#LBA54) titled, “ENTRATA: Randomized, double-blind, phase 2 study of telaglenastat (CB-839) + everolimus vs. placebo + everolimus in patients with advanced/metastatic renal cell carcinoma (RCC),” has been selected for oral presentation as part of a session titled, “Proffered Paper 1-Genitourinary tumors, non-prostate” on September 28, 2019, at 8:30 a.m. CET in Barcelona Auditorium (Hall 2). The oral presentation will be led by Chung-Han Lee of the Memorial Sloan Kettering Cancer Center, New York, NY.

 

The oral abstract (#440O) titled, “Phase 1 study of the arginase inhibitor INCB001158 (1158) alone and in combination with pembrolizumab in patients with advanced/metastatic solid tumors,” has been accepted for oral presentation as part of a session titled, “Proffered Paper – Developmental therapeutics,” on September 29, 2019, at 4:30 p.m. CET in the Malaga Auditorium (Hall 5). The oral presentation will be led by Aung Naing, M.D., FACP, Associate Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.

 

“We look forward to presenting data from the ENTRATA trial, for which positive topline results were announced earlier this year, as well as new data from our clinical program partnered with Incyte that is evaluating the arginase inhibitor INCB001158 in solid tumors,” said Susan Molineaux, Ph.D., president and chief executive officer at Calithera. “We remain committed to advancing our robust pipeline, including our lead compound telaglenastat for which the registrational CANTATA trial in RCC is underway and expected to readout in the second half of 2020.”

 

About Telaglenastat

 

Telaglenastat is an investigational first-in-class, novel glutaminase inhibitor specifically designed to block glutamine consumption in tumor cells. RCC tumors commonly exhibit metabolic alterations that increase their dependence on glutamine. In preclinical studies, telaglenastat produced synergistic anti-tumor effects when used in combination with standard-of-care RCC therapies. The randomized Phase 2 ENTRATA trial of telaglenastat plus everolimus versus everolimus plus placebo met its primary endpoint of improving progression-free survival, demonstrating proof of concept for telaglenastat in patients with advanced RCC. The ongoing CANTATA trial is a global, randomized, double-blind trial designed to evaluate the safety and efficacy of telaglenastat plus cabozantinib versus placebo plus cabozantinib in patients with advanced or metastatic RCC.

 

About INCB001158 (CB-1158)

 

INCB001158 (CB-1158) is an investigational first-in-class, novel small molecule arginase inhibitor. Arginase is an enzyme that suppresses the immune-mediated destruction of tumors by depleting levels of a key amino acid, L-arginine, from the tumor microenvironment. A number of cell types in the tumor microenvironment, including myeloid-derived suppressor cells, macrophages, and neutrophils, can secrete arginase. L-arginine deprivation can act via nutrient sensor pathways to exert several suppressive effects on T-cell function, inhibiting proliferation, decreasing cytokine production, and diminishing expression of the T-cell receptor CD3ζ chain. Arginase activity may thus impair T-cell mediated anti-tumor responses. INCB001158 is being developed in a global collaboration with Incyte Corporation.

 

About Calithera

 

Calithera Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially block tumor cells and enhance immune-cell activity. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a pipeline of first-in-clinic, oral therapeutics to meaningfully expand treatment options available to patients. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.com.

 

Forward Looking Statements

 

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “poised” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the safety, tolerability and efficacy of Calithera’s product candidates, the overall advancement of Calithera’s product candidates in clinical trials, the unmet need in the treatment of patients with advanced disease, and Calithera’s plans to continue development of its product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera’s stock price. Additional information concerning these and other risk factors affecting Calithera’s business can be found in Calithera’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, and other periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

 

# # #

 

 

Chantal Allan | Sam Brown Inc. | Healthcare Communications

Office – 805.434.9315 

Mobile – 310.270.8994 

ChantalAllan@sambrown.com | www.sambrown.com 

 

 

CONFIDENTIALITY NOTE: This e-mail message, including any attachment(s), contains information that may be confidential, protected by Sam Brown or other legal privileges, and/or proprietary non-public information. If you are not an intended recipient of this message, please notify the sender and then delete from your system.