Calithera Biosciences Announces Clinical Trial Collaboration to Evaluate IBRANCE® (palbociclib) and talazoparib in Combinati...
October 05 2018 - 7:00AM
Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage
biotechnology company focused on the development of novel cancer
therapeutics, today announced two new clinical trial collaborations
to evaluate Pfizer’s palbociclib, also known as IBRANCE®, and the
investigational dual-mechanism poly (ADP-ribose) polymerase (PARP)
inhibitor talazoparib, each in combination with Calithera’s
glutaminase inhibitor CB-839. As part of the collaboration, Pfizer
will provide palbociclib and talazoparib, as well as financial
support.
“Tumor metabolism is a unique therapeutic approach that exploits
the way in which cancer cells utilize nutrients to grow and
survive,” said Susan Molineaux, PhD, President and Chief Executive
Officer of Calithera. “CB-839, a novel glutaminase inhibitor, has
the potential to be developed in combination with palbociclib or
talazoparib to improve patient outcomes. We look forward to
collaborating with Pfizer on the combination clinical trials
planned in the first quarter of 2019.”
Preclinical data suggest that CB-839, which is designed to
starve tumor cells of the key nutrient glutamine, synergizes with
CDK4/6 inhibitors by enhancing cell cycle arrest and blocking
cancer cell proliferation. The combination of CB-839 with CDK4/6
inhibitors has demonstrated synergistic activity in a number of
preclinical cancer models, including colorectal cancer (CRC),
non-small cell lung carcinoma (NSCLC), triple negative breast
cancer (TNBC) and ER+ breast cancer. Based on these data, Calithera
will initiate a Phase 1/2 clinical trial of the combination of
CB-839 plus palbociclib in patients with KRAS mutated CRC and
patients with KRAS mutated NSCLC in the first quarter of 2019.
CB-839 also synergizes with PARP inhibitors to impair DNA
synthesis, enhance DNA damage, and block cancer cell proliferation.
The combination of CB-839 with PARP inhibitors has demonstrated
synergistic activity in a number of preclinical cancer models,
including renal cell carcinoma (RCC), TNBC, CRC, NSCLC, ovarian
cancer and prostate cancer. Based on these data, Calithera will
initiate a Phase 1/2 clinical trial of the combination of CB-839
plus talazoparib in patients with RCC, and TNBC in the first
quarter of 2019.
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 product
candidate, CB-839, is a potent, selective, reversible and orally
bioavailable 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 randomized clinical trials for the treatment of patients with
renal cell carcinoma. INCB-001158 is an immuno-oncology
metabolic checkpoint inhibitor targeting arginase, a critical
immunosuppressive enzyme responsible for T-cell suppression by
myeloid-derived suppressor cells. 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. INCB-001158 is being developed in collaboration with
Incyte Corporation. 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
timing and success of Calithera’s collaboration with Pfizer, the
potential for CB-839 to be developed in combination with
therapeutics, such as palbociclib or talazoparib, to improve
patient outcomes, the safety, tolerability and efficacy of CB-839,
the overall advancement of CB-839 in clinical trials, Calithera’s
plans to continue development of CB-839 in combination with PARP
inhibitor talazoparib for the treatment of TNBC, and RCC 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 CB-839
plus palbociclib in CRC and NSCLC patients in the first quarter of
2019. 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,
Incorporated
CONTACT:
Jennifer McNealeyir@Calithera.com650-870-1071
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