On June 4, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported that clinical data from its lead product candidate CB-839, a novel glutaminase inhibitor, will be presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), which is being held from June 1 to June 5, 2018 in Chicago, Illinois (Press release, Calithera Biosciences, JUN 4, 2018, View Source [SID1234535239]). This is the first presentation of the Case Western investigator-sponsored phase 1/2 trial evaluating CB-839 in combination with capecitabine in patients with treatment refractory advanced solid tumors. The combination demonstrated a median progression free survival of 26 weeks in seven patients with treatment-refractory advanced colorectal cancer harboring a PIKC3A mutation who had disease progression on at least one prior fluoropyrimidine-containing regimen. The data will be presented on Monday June 4, 2018 in the Developmental Therapeutics Poster Session from 8:00 a.m.-11:30 a.m. CT (Abstract #2562, Board 388).
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"Investigator sponsored studies are an important part of our strategy to develop CB-839 broadly across cancer indications," said Susan M. Molineaux, Ph.D., founder, Chief Executive Officer and President of Calithera Biosciences. "We are grateful to the investigators and Stand Up 2 Cancer for their contributions to this ongoing trial."
Dr. Jennifer Eads from Case Comprehensive Cancer Center will present the results in a poster entitled, "Phase 1 clinical trial of the glutaminase inhibitor CB-839 plus capecitabine in patients with advanced solid tumors." The phase 1 portion of the trial is designed to determine safety and the recommended dose of the combination of CB-839 and capecitabine in patients with advanced treatment refractory solid tumors, while the phase 2 portion of the trial is designed to evaluate activity of the regimen in patients with late line PIK3CA mutant colorectal cancer. To date, 16 patients have been enrolled, including 12 patients with colorectal cancer. In the dose escalation phase of the trial, there were no dose limiting toxicities and CB-839 plus capecitabine was well tolerated at full dose of CB-839. The recommended phase 2 dose for the combination is CB-839 800 mg BID with capecitabine 1000 mg/m2 BID. In patients with late-line colorectal cancer that had progressed on at least one prior fluoropyrimidine-containing regimen, the median PFS was 26 weeks for patients with PIK3CA mutated cancer (n=7) and 16 weeks for patients with PIK3CA wild-type cancer (n=5, p=0.058). The phase 2 portion of this study in patients with PIK3CA mutant colorectal cancer is ongoing.
About CB-839
Calithera’s lead product candidate, CB-839, is a potent, selective, reversible and orally bioavailable inhibitor of glutaminase. CB-839’s onco-metabolism activity takes advantage of the unique metabolic requirements of tumor cells and cancer-fighting immune cells such as cytotoxic T-cells. It is currently being evaluated in Phase 2 clinical trials in multiple tumor types in combination with standard of care agents