SOUTH SAN FRANCISCO, Calif., April 18, 2018 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq:CALA), a
clinical stage biotechnology company focused on the development of novel cancer therapeutics, today announced that the U.S. Food
and Drug Administration (FDA) has granted Fast Track designation to CB-839 in combination with cabozantinib for the treatment of
patients with metastatic renal cell carcinoma who have received one or two prior lines of therapy, including at least one vascular
endothelial growth factor tyrosine kinase inhibitor or the combination of nivolumab and ipilimumab. CB-839 is a
first-in-class, oral, selective, potent inhibitor of glutaminase being evaluated in the CANTATA trial. The trial is a
randomized double-blind clinical study of cabozantinib in combination with CB-839 or placebo in 298 patients with clear cell renal
cell carcinoma. The primary endpoint is progression free survival and the global study is open for enrollment.
“Despite a number of new therapies for the treatment of renal cell carcinoma, there remains a significant unmet need among
advanced patients who have received prior treatment,” said Susan Molineaux, PhD, President and Chief Executive Officer of
Calithera. “We are pleased that CB-839 has been granted Fast Track designation, demonstrating the FDA’s commitment to
facilitate the development and expedite the review of our glutaminase inhibitor as an important new therapy for patients with
advanced or metastatic renal cell carcinoma who have failed prior systemic therapy.”
The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics, to
treat serious or life threatening conditions, and to fill an unmet medical need. Specifically, Fast Track designation
facilitates frequent interactions with the FDA review team, including meetings to discuss all aspects of development to support
approval, and also provides the opportunity to submit sections of an NDA on a rolling basis as data become available.
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, the overall advancement of CB-839 in clinical trials, the unmet need in the
treatment of patients with advanced disease, the timing of the FDA’s review of CB-839 and whether the FDA will support further
development of CB-839, and Calithera’s plans to continue development of CB-839 in combination with cabozantinib for the treatment
of clear cell renal cell carcinoma. 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.
SOURCE: Calithera Biosciences, Incorporated
CONTACT:
Jennifer McNealey
ir@Calithera.com
650-870-1071
