Updated Results from Phase I Study of CB-839 in Combination with Paclitaxel in Patients with Triple Negative Breast Cancer to...
December 05 2017 - 8:00AM
Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage
biotechnology company focused on discovering and developing novel
small molecule drugs directed against tumor metabolism and tumor
immunology targets for the treatment of cancer, announced today
that updated clinical data from its lead product candidate CB-839,
a first-in-class glutaminase inhibitor, will be presented at the
2017 San Antonio Breast Cancer Symposium, December 5-9, 2017 in San
Antonio, Texas. The data demonstrate the clinical activity
and tolerability of CB-839 in combination with paclitaxel, and
highlight the unique mechanism of action of CB-839 in patients with
advanced/metastatic triple negative breast cancer (TNBC).
Based on these data, Calithera has opened a Phase 2 trial
exploring the treatment combination in both first line and late
line metastatic TNBC patients.
“Effective treatment for triple negative breast cancer in the
advanced and metastatic population remains a significant unmet
need. In our Phase 1 study, we were pleased to have observed
responses in patients who were heavily pretreated and the Phase 2
study will help us further understand the role of CB-839 in
inhibiting glutaminase to help control the progression of cancer in
advanced metastatic TNBC patients,” said Susan Molineaux, PhD,
President and Chief Executive Officer of Calithera.
In a poster presentation representing an update from data
presented at SABCS 2016, Dr. Kevin Kalinsky from Columbia
University Medical Center will present, “Phase I study of CB-839, a
first-in-class inhibitor of glutaminase, in combination with
paclitaxel in patients with advanced triple negative breast
cancer,” (Abstract PD3-13). Eligible patients must have
locally advanced/metastatic TNBC, with no restrictions on prior
exposure to taxanes, or the number of prior therapies. As of
October 23, 2017, 49 triple negative breast cancer patients had
been treated with doses of CB-839 of 400, 600 or 800 mg bid in
combination with 80 mg/m2 IV paclitaxel, weekly, three weeks out of
four; 44 were evaluable for response. Patients were heavily
pretreated, having received a median of 3 prior therapies for
advanced metastatic disease. A majority of patients had
received prior taxane therapy in either the neo-adjuvant (37%) or
metastatic setting (51%). Among all evaluable patients
treated with CB-839 doses of at least 600 mg bid (n=37), there were
8 partial responses (22%) and disease control (response or stable
disease) in 22 patients (59%). Among African Americans, there
was a 36% response rate in patients who had received previous
taxanes in the metastatic setting; all responders were refractory
to prior taxanes. Exploratory biomarker analysis shows a
trend for the strongest clinical benefit occurring in patients with
LAR and/or desmoplastic stromal gene expression signatures1.
The combination of CB-839 and paclitaxel has been well tolerated
to date, with adverse events that have been primarily low grade and
reversible. Consistent with the previous report, there was
one case of dose-limiting, recurrent grade 3 neutropenia at the 400
mg dose level, which led to a reduction in the dose of paclitaxel
for that patient. The most frequent adverse event ≥ Grade 3
was neutropenia (27%). A low rate of ≥ Grade 3 peripheral
neuropathy (4.2%) was observed despite 88% of the patients having
prior taxane exposure.
1Lehmann et al., J Clin Invest 2011; Chen et al, Cancer Inform
2012; Jovanovic et al BMC Cancer 2017; Saleh et al, Cancer Research
2017
About CB-839
Calithera’s lead product candidate, CB-839, is a potent,
selective, reversible and orally bioavailable inhibitor of
glutaminase. CB-839’s onco-metabolism activity takes
advantage of the unique metabolic requirements of tumor cells and
cancer-fighting immune cells such as cytotoxic T-cells. It is
currently being evaluated in Phase 2 clinical trials in multiple
tumor types, in combination with standard of care agents.
About Calithera
Calithera is a clinical-stage biopharmaceutical company focused
on fighting cancer 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
safety, tolerability and efficacy of CB-839, Calithera’s ability to
understand the role of CB-839 in inhibiting glutaminase to help
control the progression of cancer in TNBC patients, and the
advancement of CB-839 in 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 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 McNealey
ir@Calithera.com
650-870-1071
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