Calithera Biosciences, Inc. (Nasdaq:CALA), 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, today announced the
initiation of a randomized Phase 2 trial of CB-839, the company’s
glutaminase inhibitor, combined with AFINITOR® (everolimus) in
patients with clear cell renal cell carcinoma.
“Despite the advances in the treatment of renal cell carcinoma,
there remains significant unmet need for patients who have
progressed following treatment with an anti-PD1 and/or tyrosine
kinase inhibitors,” said Susan Molineaux, PhD, President and Chief
Executive Officer of Calithera. “The initiation of this study
marks an important milestone for our company, as it is the first
randomized trial of CB-839 that we believe has the potential for
U.S Food and Drug Administration (FDA) registration and
approval. In recognition of the lack of treatment options
available to patients with renal cell carcinoma, the FDA has
granted Fast Track Designation to CB-839 in this setting.”
The randomized, double-blind, placebo controlled trial is
designed to evaluate the safety and efficacy of CB-839 in
combination with everolimus versus placebo with everolimus in
approximately 250 patients with metastatic, clear cell renal cell
carcinoma (RCC) patients who have been treated with at least two
prior lines of systemic therapy including a VEGFR-targeting
tyrosine kinase inhibitor and at least one of either CABOMETYX™
(cabozantinib) or an active PD-1/PD-L1 inhibitor. Patients
will be randomized in a 2:1 ratio. The primary endpoint is
progression free survival assessed by an independent review
committee; overall survival will be assessed as a secondary
endpoint. The multicenter, international study will be conducted at
multiple sites in the United States, Europe and Canada.
Clinical trial sites have been activated and the study is
open for enrollment. For a listing of clinical sites and
additional details about the clinical trial, please see
www.clinicaltrials.gov (NCT03163667).
CB-839 takes advantage of the pronounced dependency many cancers
have on the nutrient glutamine for growth and survival.
CB-839 inhibits glutaminase, an enzyme required by cancer
cells to utilize glutamine effectively, resulting in inhibition of
tumor growth. In 2017, RCC is estimated to be
diagnosed in approximately 63,990 people in the United States,
according to the National Cancer Institute. Clear cell is the
most common form of kidney cancer, comprising 70-75% of cases.
Most patients with clear cell RCC lack the tumor suppressor
gene VHL, making them more dependent on glutamine due to a loss of
ability to make fatty acids from glucose1,2,3. Since the mTOR
inhibitor everolimus impairs the use of glucose by cancer cells,
the combination of CB-839 with everolimus induces dual metabolic
inhibition.
About Calithera 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 an 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 2 clinical
trials in combination with standard of care agents. Calithera is
also developing CB-1158, in collaboration with Incyte Corporation,
an investigational immuno-oncology metabolic checkpoint inhibitor
designed to target arginase, a critical immunosuppressive enzyme
responsible for T-cell suppression by myeloid-derived suppressor
cells (MDSCs). 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. CB-1158
is currently in a Phase I clinical trial. Calithera is
headquartered in South San Francisco, California. For more
information about Calithera, please visit
http://www.calithera.com/.
Forward Looking StatementsStatements 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
advancement of the Company’s clinical trials, the review,
registration and approval of CB-839 by the FDA, and the safety and
efficacy of CB-839. 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.
1Proc Natl Acad Sci U S A. 2011 Dec 6;108(49):19611-6.Hypoxia
promotes isocitrate dehydrogenase-dependent carboxylation of
α-ketoglutarate to citrate to support cell growth and viability.
Wise DR, Ward PS, Shay JE, Cross JR, Gruber JJ, Sachdeva UM, Platt
JM, DeMatteo RG, Simon MC, Thompson CB.
2Nature. 2011 Nov 20;481(7381):380-4. Reductive glutamine
metabolism by IDH1 mediates lipogenesis under hypoxia. Metallo CM1,
Gameiro PA, Bell EL, Mattaini KR, Yang J, Hiller K, Jewell CM,
Johnson ZR, Irvine DJ, Guarente L, Kelleher JK, Vander Heiden MG,
Iliopoulos O, Stephanopoulos G.
3Cell Metab. 2013 Mar 5;17(3):372-85. doi:
10.1016/j.cmet.2013.02.002. In vivo HIF-mediated reductive
carboxylation is regulated by citrate levels and sensitizes
VHL-deficient cells to glutamine deprivation. Gameiro PA1,
Yang J, Metelo AM, Pérez-Carro R, Baker R, Wang Z, Arreola A,
Rathmell WK, Olumi A, López-Larrubia P, Stephanopoulos G,
Iliopoulos O.
Contact:
Jennifer McNealey
ir@Calithera.com
650-870-1071
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