On October 5, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage pharmaceutical company focused on discovering and developing small molecule drugs that target novel and critical metabolic pathways in tumor and cancer-fighting immune cells, reported that it will provide an update on the company’s growing research pipeline of novel therapies in oncology and cystic fibrosis during an R&D day hosted today in New York City (Press release, Calithera Biosciences, OCT 5, 2018, View Source [SID1234535234]).

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Calithera management, including Susan Molineaux, PhD, President and Chief Executive Officer and Keith Orford, MD, PhD, Senior Vice President of Clinical Development will discuss progress on Calithera’s clinical and emerging programs. Nizar Tannir, MD, Deputy Department Chair, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center will discuss the advanced renal cell carcinoma treatment landscape.

"R&D Day is an opportunity to provide additional insight into our clinical development programs, delineate key milestones, and highlight our innovative pipeline," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "In 2019, we plan to report data from our Phase 2 ENTRATA study in renal cell carcinoma. In addition, we and our partner Incyte expect data on INCB001158 to be presented at a medical meeting in the first half of 2019.

Pipeline Highlights

During R&D Day, Calithera will discuss its clinical development pipeline of innovative therapies including:

Two Randomized Phase 2 Combination Trials of CB-839 for the Treatment of Patients with Renal Cell Carcinoma. The ENTRATA trial, a randomized double-blind placebo-controlled study of late line patients, will enroll approximately 66 patients to receive either everolimus and CB-839 or everolimus alone. Topline results are expected in 2019. CANTATA is a randomized, global, double-blind, placebo-controlled trial comparing patients treated with cabozantinib and CB-839 to patients treated with cabozantinib alone. This trial will enroll approximately 300 clear cell renal cell carcinoma patients who have previously received one or two prior lines of therapy. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CB-839 in combination with cabozantinib for the treatment of this patient population.

CB-839 Phase 1b Cabozantinib Combination Data in Patients with Advanced Renal Cell Carcinoma. Updated results of CB-839 in combination with cabozantinib will be presented. In the Phase 1b trial, 12 advanced renal cell carcinoma patients, including 10 clear cell and two papillary patients, were treated with CB-839 plus cabozantinib and were evaluable for response. Patients enrolled in the trial have advanced or metastatic disease and had received a median of three prior treatments, which included tyrosine kinase inhibitors, mTOR inhibitors, and checkpoint inhibitors. One hundred percent of evaluable patients experienced tumor shrinkage and disease control, including five patients who had a partial response and seven patients who had stable disease. In the clear cell patient population, the disease control rate was 100% and the response rate was 50%.

Pfizer collaboration to develop CB-839 in combination with PARP inhibitors and CDK4/6 inhibitors. As part of a clinical collaboration with Pfizer announced today, Calithera will initiate Phase 1/2 clinical studies in the first quarter of 2019. Preclinical data suggest that CB-839 synergizes with CDK4/6 inhibitors by enhancing cell cycle arrest and blocking cancer cell proliferation. CB-839 also synergizes with PARP inhibitors to impair DNA synthesis, enhance DNA damage, and block cancer cell proliferation.

INCB001158 Arginase Inhibitor Immuno-oncology Program. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with solid tumors both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with Incyte. Data from INCB001158 is expected to be presented at a medical meeting in the first half of 2019.

CB-280 Arginase Inhibitor for the Treatment of Cystic Fibrosis. Arginase is believed to be critical in the pathology of cystic fibrosis. It impairs production of nitric oxide and generates metabolites of arginine that may impair lung function. CB-280 is an orally administered small molecule inhibitor of arginase. An investigational new drug (IND) application for CB-280 with the U.S. FDA is planned for the first half of 2019.

CB-708 Oral Small Molecule CD73 Inhibitor. The immuno-oncology target CD73 is an enzyme that plays a critical role in the process of ATP conversion to adenosine. An IND application for CB-708, an orally administered small molecule inhibitor of CD73, is planned for 2019. Webcast Information Calithera will host R&D Day today from 8:00 a.m.-10:15 a.m. ET in New York, NY. For those not able to attend, a live webcast that will include audio and slides of the presentation can be accessed through the Investors section of the Company’s website at www.calithera.com. Following the live presentations, a replay of the webcast will be available on the company’s website for at least 90 days