Phase 2 to Continue Enrolling Colorectal Cancer Patients with PIK3CA Mutation
SOUTH SAN FRANCISCO, Calif., June 04, 2018 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq:CALA), a
clinical stage biotechnology company focused on the development of novel cancer therapeutics, announced today 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), which is being held from June 1 to June 5, 2018 in Chicago, Illinois. 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).
"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.
About Calithera
Calithera is a clinical-stage biopharmaceutical company focused on fighting cancer by discovering, developing,
and commercializing novel small molecule drugs that target tumor and immune cell metabolism. 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 CB-839 and the overall advancement of CB-839 in clinical trials, and Calithera’s plans
to continue development of CB-839 in combination with capecitabine in patients with advanced treatment refractory solid tumors and
late line PIK3CA mutant colorectal cancer. 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 Annual
Report on Form 10-K 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.
NOTE:
Research supported by a Stand Up To Cancer Colorectal Cancer Dream Team Translational Research Grant (Grant
Number: SU2C-AACR-DT22-17). Stand Up To Cancer is a program of the Entertainment Industry Foundation. Research grants are
administered by the American Association for Cancer Research, the scientific partner of SU2C.
SOURCE: Calithera Biosciences, Inc.
CONTACT:
Jennifer McNealey
ir@Calithera.com
650-870-1071
