Calithera Announces First Patient Dosed in a Phase I Study of CB-1158, the First-in-Class Inhibitor of the Immuno-Oncology Ta...
September 15 2016 - 7:45AM
Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage
biotechnology company focused on the development of novel cancer
therapeutics, today announced that the first patient has been dosed
in a Phase I clinical trial assessing the safety and efficacy of
CB-1158, a first-in-class arginase inhibitor for the treatment of
advanced solid tumors. Arginase is an enzyme in
myeloid-derived suppressor cells (MDSCs), which prevents T-cell and
natural killer (NK) cell activation in tumors.
"Arginase, when released by MDSCs, plays an important role in
the inhibition of T-cell and NK-cell activation and proliferation,
preventing immune-mediated anti-tumor activity. For example,
in many solid tumors, including lung, colorectal, esophageal,
bladder, head and neck, and kidney cancer, arginase-expressing
MDSCs accumulate, establishing an immunosuppressive
microenvironment by blocking the ability of T-cells and NK-cells to
kill cancer cells. We believe that inhibitors of arginase can
promote an anti-tumor immune response and augment the activity of
checkpoint inhibitors," said Susan M. Molineaux, Ph.D., founder,
Chief Executive Officer and President of Calithera Biosciences.
"We look forward to reporting initial clinical results with
this compound in 2017.”
Arginase exerts its immunosuppressive effect by depleting the
amino acid arginine in the tumor microenvironment and preventing
activation and proliferation of the immune system’s cytotoxic
T-cells and NK-cells. We believe that inhibitors of arginase
activity promote an anti-tumor immune response by restoring
arginine levels in the tumor and reversing this immunosuppressive
metabolic checkpoint. The Phase I clinical trial will enroll
patients with advanced solid tumors treated with CB-1158 as a
monotherapy, as well as in combination with an anti-PD1
therapy.
About Calithera Biosciences
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 1/2 clinical trials in combination with standard of care
agents. CB-1158 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. 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-1158, enrollment of the
combination expansion cohorts of CB-1158 and the presentation of
data in 2017. 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 most recent
Quarterly Report on Form 10-Q 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.
CONTACT:
Jennifer McNealey
ir@Calithera.com
650-870-1071
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