Calithera Biosciences Announces FDA Fast Track Designation Granted to CB-839 in Combination with Cabozantinib for Treatment o...
April 18 2018 - 7:01AM
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 McNealeyir@Calithera.com650-870-1071
Calithera Biosciences (NASDAQ:CALA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Calithera Biosciences (NASDAQ:CALA)
Historical Stock Chart
From Apr 2023 to Apr 2024