Calithera Announces First Patient Treated in Phase 1 Cohort of INCB01158 dosed in Combination with Keytruda
October 19 2017 - 08:00AM
Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage
pharmaceutical company focused on discovering and developing novel
small molecule drugs directed against tumor metabolism and tumor
immunology targets for the treatment of cancer, today announced
that the first patient has been treated in the Phase 1 cohort of
INCB01158 (also known as CB-1158) in combination with Keytruda®
(pembrolizumab), an anti-PD1 immune checkpoint inhibitor. INCB01158
is a potent, selective, oral inhibitor of arginase being developed
pursuant to a global collaboration and license agreement with
Incyte Corporation.
"Arginase is involved in the metabolism of a key amino acid that
is required for optimal anti-cancer immune function," said Susan M.
Molineaux, Ph.D., founder, Chief Executive Officer and President of
Calithera Biosciences. "In combination with an anti-PD1 therapy, an
inhibitor of arginase may reduce immunosuppression caused by
myeloid cells and broaden the reach of immuno-oncology
therapies."
The Phase 1 trial (NCT02903914) is designed to evaluate the
safety and recommended Phase 2 dose of INCB01158 as a monotherapy,
and in combination with immune checkpoint therapy. The trial was
initiated in September 2016 and is designed to enroll monotherapy
expansion cohorts of patients with advanced non-small cell lung
cancer, colorectal cancer and other solid tumors. The recommended
Phase 2 monotherapy dose has been selected, and several cohorts of
additional tumor types have been added to the trial design.
Expansion cohorts of INCB01158 dosed in combination with Keytruda®
are expected to enroll patients diagnosed with non-small cell lung
cancer, melanoma, urothelial cell carcinoma, colorectal cancer,
gastroesophageal cancer, squamous cell head and neck cancer and
mesothelioma.
About Calithera Calithera Biosciences, Inc. is
a clinical-stage pharmaceutical company focused on discovering and
developing novel small molecule drugs directed against tumor
metabolism and tumor immunology targets for the treatment of
cancer. Calithera’s lead product candidate, CB-839, is a potent,
selective, reversible and orally bioavailable inhibitor of
glutaminase. CB-839 takes advantage of the pronounced dependency
many cancers have on the nutrient glutamine for growth and
survival. It is currently being evaluated in Phase 2 clinical
trials in combination with standard of care agents. INCB01158 is a
first-in-class immuno-oncology metabolic checkpoint inhibitor
targeting arginase, a critical immunosuppressive enzyme responsible
for T-cell suppression by myeloid-derived suppressor cells.
Arginase depletes arginine, a nutrient that is critical for the
activation, growth and survival of the body’s cancer-fighting
immune cells, known as cytotoxic T-cells. INCB01158 is being
developed in a global collaboration and license agreement with
Incyte Corporation and is currently in a Phase 1 clinical trial.
Calithera is headquartered in South San Francisco, California. For
more information about Calithera, please visit
www.calithera.com.
Forward Looking StatementsStatements 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 timing of Calithera’s
clinical trials, the clinical and commercial potential of its
product candidates, including whether INCB01158 will be effective
in the treatment of cancer or successfully advance through clinical
studies, Calithera’s ability to fund its clinical programs, and
Calithera’s receipt of clinical data from its clinical trials.
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 potential 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 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.
Contact:Jennifer
McNealeyir@Calithera.com650-870-1071
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