Calithera Biosciences Initiates Phase 1/2 Trial of Telaglenastat in Combination with the PARP Inhibitor Talazoparib
March 26 2019 - 6:05AM
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 the first patient
has been treated in the Phase 1/2 open-label clinical trial of the
glutaminase inhibitor telaglenastat (CB-839) in combination with
Pfizer’s poly adenosine diphosphate ribose polymerase (PARP)
inhibitor talazoparib, also known as Talzenna®, in patients with
advanced or metastatic solid tumors.
“The initiation of this clinical trial of telaglenastat in
combination with talazoparib marks the first of two clinical trials
that will evaluate telaglenastat with approved Pfizer therapeutics
as part of this collaboration,” said Susan Molineaux, PhD,
president and chief executive officer of Calithera. "We believe
these new combination trials have the potential to broaden the
opportunities for telaglenastat to improve patient outcomes.”
Preclinical studies have shown that telaglenastat synergizes
with PARP inhibitors to impair DNA synthesis, enhance DNA damage
and block cancer cell proliferation. The combination of
telaglenastat with PARP inhibitors has demonstrated synergistic
activity in a number of preclinical cancer models, including renal
cell carcinoma (RCC), triple negative breast cancer (TNBC),
colorectal cancer (CRC), non-small cell lung cancer (NSCLC),
ovarian cancer and prostate cancer. In October 2018, Calithera
entered into a clinical trial collaboration agreement with Pfizer
to evaluate telaglenastat in two clinical trials. The first trial
is a combination of telaglenastat with talazoparib and the second
trial is a combination of telaglenastat with palbociclib, also
known as Ibrance®. As part of this agreement, Pfizer will provide
palbociclib and talazoparib, as well as financial support.
The Phase 1/2 trial (NCT03875313) will evaluate the safety and
efficacy of the combination of telaglenastat plus talazoparib in
patients with locally advanced/metastatic RCC, TNBC and CRC that
are refractory or intolerant to standard therapies. The trial will
evaluate the potential of telaglenastat to sensitize tumors to
talazoparib in patients regardless of mutations in the BRCA
gene.
Telaglenastat is an investigational, novel glutaminase inhibitor
specifically designed to block glutamine consumption in tumor
cells. Tumors commonly exhibit metabolic alterations that increase
their dependence on glutamine. In preclinical studies,
telaglenastat produced synergistic antitumor effects when used in
combination with standard-of-care therapies.
About Calithera
Calithera is a clinical-stage biopharmaceutical company focused
on fighting cancer and other life-threatening diseases 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 success
of Calithera’s collaboration with Pfizer, the potential for
telaglenastat to be developed in combination with therapeutics,
such as palbociclib or talazoparib, to improve patient outcomes,
safety, tolerability and efficacy of telaglenastat, the overall
advancement of telaglenastat in clinical trials, the unmet need in
the treatment of patients with advanced disease, Calithera’s plans
to continue development of telaglenastat in combination with PARP
inhibitor talazoparib for the treatment of TNBC, RCC and TNBC as
well as the related timing for clinical trials, and Calithera’s
plans to initiate a Phase 1/2 clinical trial of the combination of
telaglenastat plus palbociclib in CRC and NSCLC patients. 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, Inc.
CONTACT: Jennifer McNealey
ir@Calithera.com
650-870-1071
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