Data from Investigator-Sponsored Phase 2 Study of Calithera’s Telaglenastat with Azacitidine in Myelodysplastic Syndrome to be Presented at ASH Annual Meeting 2019
SOUTH SAN FRANCISCO, Calif., Dec. 06, 2019 (GLOBE NEWSWIRE) — 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 preliminary safety and efficacy data from an investigator-sponsored trial evaluating telaglenastat (CB-839) in combination with azacitidine will be presented in an oral session at the American Society of Hematology (ASH) Annual Meeting 2019 taking place December 7-10, in Orlando, Florida.
“Telaglenastat is being evaluated in multiple tumor types through investigator-sponsored trials, and we are excited to see progress as data from these trials are beginning to be presented at prestigious conferences such as ASH,” said Susan Molineaux, PhD, president and chief executive officer of Calithera. “We are grateful to the patients and clinicians who are participating in all trials evaluating glutaminase inhibition as a novel approach to the treatment of cancer, and we continue to observe through these trials the potential of telaglenastat in a wide range of cancer indications.”Presentation details:Date: Monday, December 9 at 7:30 a.m. Eastern TimeTitle: Interim Analysis of Phase 2 Study of Telaglenastat in combination with Azacitidine in Myelodysplastic SyndromePresenter: Veronica A Guerra, M.D, University of Texas MD Anderson Cancer CenterSession: 637. Myelodysplastic Syndromes—Clinical Studies: Combination TherapiesLocation: W311EFGH, Level 3 (Orange County Convention Center)Telaglenastat is an investigational first-in-class glutaminase inhibitor specifically designed to block glutamine consumption in tumor cells.Additional meeting information and accepted abstracts can be found at the ASH website www.hematology.org.About The StudyThis investigator-sponsored trial is a single arm Phase 1b/2 trial of telaglenastat in combination with azacitidine for intermediate and high-risk MDS. Eligible patients included adults at least 18 years with high-risk MDS (IPSS intermediate-2 or high risk) or intermediate-1 risk with high-risk genomic features including TP53, ASXL1, EZH2, or RUNX1 mutations. The primary outcome was to confirm the safety and recommended dose of telaglenastat in combination with azacitidine. Secondary endpoints evaluate the pharmacokinetic and pharmacodynamic effects of telaglenastat in combination with azacitidine, clinical activity of the combination by IWG response criteria, as well as overall survival and event free survival.About CalitheraCalithera 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 StatementsStatements 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, including the potential for telaglenastat to be developed in combination with therapeutics, such as azacitidine, the overall advancement and timing 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.SOURCE: Calithera Biosciences, Incorporated