Calithera Biosciences Initiates Phase 1b Trial of Arginase Inhibitor CB-280 for the Treatment of Cystic Fibrosis
13 Juli 2020 - 1:00PM
Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage
biotechnology company focused on discovering and developing novel
small molecule drugs for the treatment of cancer and other
life-threatening diseases, today announced that it has dosed the
first patients in its Phase 1b clinical trial of the arginase
inhibitor CB-280 in adult patients with cystic fibrosis (CF) and
chronic airway infection. The study will evaluate the safety and
optimal dose range of CB-280 when added onto existing therapies for
CF patients, including CFTR modulators.
“We remain committed to advancing our arginase inhibitor
clinical development program to fully explore the potential of this
new class of therapeutics in a variety of conditions,” said Susan
Molineaux, PhD, president and chief executive officer of Calithera.
“Based on preclinical data and the unique pathology of this
disease, we believe that CB-280’s mechanism of action represents an
opportunity to further improve upon the current standard-of-care
for CF patients, for whom there remains great unmet need despite
recent therapeutic advancements.”
Research in CF patients has demonstrated that increased arginase
activity correlates directly with worsened lung function, and
reduced expiratory nitric oxide (NO) levels. Pre-clinical studies
conducted by Calithera and collaborators have shown that arginase
inhibition increases systemic arginine levels, decreases airway
bacterial colonies, and improves lung function in CF mouse models
of infection. Inhibiting arginase may reduce infection and improve
lung function in people with CF. Chronic poly-microbial infection
remains a major area of unmet need in CF.
The Phase 1b randomized, double blind, placebo-controlled, dose
escalation trial will evaluate multiple ascending doses of CB-280
compared to placebo in 32 adult CF patients to determine a safe
dose range for CB-280, dosed orally twice daily for 14 days. The
study follows the completion of a Phase 1 trial that evaluated the
safety, tolerability and pharmacokinetic profile of CB-280 in
healthy volunteers, which was conducted under a United States Food
and Drug Administration Investigational New Drug (IND)
application.
In October 2017, Calithera entered into a global collaboration
agreement with Incyte, focused on research, development and
commercialization of a first-in-class arginase inhibitor in
hematology and oncology. As part of this agreement, Calithera
retained the rights to develop additional arginase inhibitors in
specific non-oncology indications, including CF. The molecule being
evaluated in these clinical trials, CB-280, is wholly owned by
Calithera.
About Calithera
Calithera Biosciences is a clinical-stage biopharmaceutical
company pioneering the discovery and development of targeted
therapies that disrupt cellular metabolic pathways to
preferentially block tumor cells and enhance immune-cell activity.
Driven by a commitment to rigorous science and a passion for
improving the lives of people impacted by cancer and other
life-threatening diseases, Calithera is advancing a pipeline of
first-in-clinic, oral therapeutics to meaningfully expand treatment
options available to patients. 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 the arginase inhibitor CB-280 in adult
patients with cystic fibrosis, the overall advancement of CB-280 in
the Phase 1b clinical trial , the unmet need in the treatment of
patients despite recent therapeutic advancements, Calithera’s
global collaboration with Incyte, and Calithera’s plans to continue
development of CB-280. 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 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.
SOURCE: Calithera Biosciences, Inc.
CONTACTS:
Investor RelationsJennifer
McNealeyCalitherair@Calithera.com650-870-1071
MediaMichele ParisiSam Brown,
Inc.micheleparisi@sambrown.com925-864-5028
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