Calithera Biosciences Completes Patient Enrollment in Randomized CANTATA Trial of Telaglenastat and Cabozantinib in Advanced ...
October 03 2019 - 7:05AM
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 it has completed
patient enrollment in the ongoing CANTATA trial. CANTATA is a
global, randomized double-blind clinical trial of the glutaminase
inhibitor telaglenastat (CB-839) combined with cabozantinib, a
standard of care, in patients with advanced or metastatic renal
cell carcinoma (RCC) who have received one or two prior treatments.
The study is designed with registrational intent. Exelixis, Inc. is
providing cabozantinib for the trial through a material supply
agreement with Calithera.
“We are grateful that both clinicians and patients have
expressed real interest in the CANTATA trial, enabling us to
complete enrollment ahead of schedule,” said Susan Molineaux, PhD,
president and chief executive officer of Calithera. “This is an
important milestone in the clinical progress of telaglenastat, our
novel glutaminase inhibitor. Despite the introduction of new
therapies, the treatment of patients with advanced renal cell
carcinoma who have progressed on initial treatments remains a
critical unmet need.”
The CANTATA trial (NCT03428217) is a global, randomized,
double-blind trial designed to evaluate the efficacy and safety of
telaglenastat in combination with cabozantinib versus placebo with
cabozantinib in patients with advanced or metastatic RCC who have
been treated with one or two prior lines of systemic therapy,
including at least one vascular endothelial growth factor (VEGF)
tyrosine kinase inhibitor or the combination of nivolumab and
ipilimumab. In April 2018, the U.S. Food and Drug Administration
granted Fast Track designation to telaglenastat in this indication.
The CANTATA trial enrolled 445 patients at multiple centers
globally. The primary endpoint is progression-free survival by
blinded independent review, and a key secondary endpoint is overall
survival. Calithera plans to report top-line efficacy and safety
data from the trial in the second half of 2020.
Telaglenastat is an investigational first-in-class glutaminase
inhibitor specifically designed to block glutamine consumption in
tumor cells. RCC 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 RCC therapies. Earlier this year,
Calithera announced that a randomized Phase 2 trial of
telaglenastat plus everolimus versus everolimus plus placebo
(ENTRATA) met its primary endpoint of improving progression free
survival, demonstrating proof of concept for telaglenastat in
patients with advanced RCC.
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 Calithera’s product candidates,
including the potential for telaglenastat to be developed in
combination with therapeutics, such as everolimus or cabozantinib,
the overall advancement and timing of Calithera’s product
candidates in clinical trials, the unmet need in the treatment of
patients with advanced disease, and Calithera’s plans to continue
development of its product candidates. 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,
Incorporated
CONTACT:
Jennifer
McNealeyir@Calithera.com650-870-1071
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