Calithera Biosciences Highlights Breadth of Innovative Pipeline at R&D Day
October 05 2018 - 7:01AM
-Updated response rate of 50% in advanced renal
carcinoma treated with CB-839 + cabozantinib-CB-839 clinical trial
collaboration with Pfizer -Presentation of INCB001158 data expected
in 1H2019-R&D day hosted today in New York from 8:00 a.m.
-10:15 a.m. ET, live webcast available
Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage
pharmaceutical company focused on discovering and developing small
molecule drugs that target novel and critical metabolic pathways in
tumor and cancer-fighting immune cells, will provide an update on
the company’s growing research pipeline of novel therapies in
oncology and cystic fibrosis during an R&D day hosted today in
New York City.
Calithera management, including Susan Molineaux, PhD, President
and Chief Executive Officer and Keith Orford, MD, PhD, Senior Vice
President of Clinical Development will discuss progress on
Calithera’s clinical and emerging programs. Nizar Tannir, MD,
Deputy Department Chair, Department of Genitourinary Medical
Oncology, Division of Cancer Medicine, University of Texas MD
Anderson Cancer Center will discuss the advanced renal cell
carcinoma treatment landscape.
“R&D Day is an opportunity to provide additional insight
into our clinical development programs, delineate key milestones,
and highlight our innovative pipeline,” said Susan Molineaux, PhD,
President and Chief Executive Officer of Calithera. “In 2019,
we plan to report data from our Phase 2 ENTRATA study in renal cell
carcinoma. In addition, we and our partner Incyte expect data on
INCB001158 to be presented at a medical meeting in the first half
of 2019.”
Pipeline Highlights
During R&D Day, Calithera will discuss its clinical
development pipeline of innovative therapies including:
- Two Randomized Phase 2 Combination Trials of CB-839 for
the Treatment of Patients with Renal Cell Carcinoma.
The ENTRATA trial, a randomized double-blind placebo-controlled
study of late line patients, will enroll approximately 66 patients
to receive either everolimus and CB-839 or everolimus alone.
Topline results are expected in 2019. CANTATA is a
randomized, global, double-blind, placebo-controlled trial
comparing patients treated with cabozantinib and CB-839 to patients
treated with cabozantinib alone. This trial will enroll
approximately 300 clear cell renal cell carcinoma patients who have
previously received one or two prior lines of therapy. The U.S.
Food and Drug Administration (FDA) has granted Fast Track
designation for CB-839 in combination with cabozantinib for the
treatment of this patient population.
- CB-839 Phase 1b Cabozantinib Combination Data in
Patients with Advanced Renal Cell Carcinoma. Updated
results of CB-839 in combination with cabozantinib will be
presented. In the Phase 1b trial, 12 advanced renal cell
carcinoma patients, including 10 clear cell and two papillary
patients, were treated with CB-839 plus cabozantinib and were
evaluable for response. Patients enrolled in the trial have
advanced or metastatic disease and had received a median of three
prior treatments, which included tyrosine kinase inhibitors, mTOR
inhibitors, and checkpoint inhibitors. One hundred percent of
evaluable patients experienced tumor shrinkage and disease control,
including five patients who had a partial response and seven
patients who had stable disease. In the clear cell patient
population, the disease control rate was 100% and the response rate
was 50%.
- Pfizer collaboration to develop CB-839 in combination
with PARP inhibitors and CDK4/6 inhibitors. As part
of a clinical collaboration with Pfizer announced today, Calithera
will initiate Phase 1/2 clinical studies in the first quarter of
2019. Preclinical data suggest that CB-839 synergizes with
CDK4/6 inhibitors by enhancing cell cycle arrest and blocking
cancer cell proliferation. CB-839 also synergizes with PARP
inhibitors to impair DNA synthesis, enhance DNA damage, and block
cancer cell proliferation.
- INCB001158 Arginase Inhibitor Immuno-oncology
Program. INCB001158 is being evaluated in multiple
clinical trials for the treatment of patients with solid tumors
both as a monotherapy, and in combination with immunotherapies and
chemotherapy. INCB001158 is being developed as part of a
collaboration and license agreement with Incyte. Data from
INCB001158 is expected to be presented at a medical meeting in the
first half of 2019.
- CB-280 Arginase Inhibitor for the Treatment of Cystic
Fibrosis. Arginase is believed to be critical in the
pathology of cystic fibrosis. It impairs production of nitric oxide
and generates metabolites of arginine that may impair lung
function. CB-280 is an orally administered small molecule inhibitor
of arginase. An investigational new drug (IND) application for
CB-280 with the U.S. FDA is planned for the first half of
2019.
- CB-708 Oral Small Molecule CD73
Inhibitor. The immuno-oncology target CD73 is an
enzyme that plays a critical role in the process of ATP conversion
to adenosine. An IND application for CB-708, an orally administered
small molecule inhibitor of CD73, is planned for 2019.
Webcast Information
Calithera will host R&D Day today from 8:00 a.m. - 10:15
a.m. ET in New York, NY. For those not able to attend, a live
webcast that will include audio and slides of the presentation can
be accessed through the Investors section of the Company's website
at www.calithera.com. Following the live presentations, a
replay of the webcast will be available on the company’s website
for at least 90 days.
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
advancement of Calithera’s programs toward key milestones;
Calithera’s product pipeline; timing and enrollment of Calithera’s
clinical trials, including the ENTRATA trial; and Calithera’s and
Incyte’s receipt and presentation of clinical data from their
clinical trials; the expansion of development of CB-839 in
combination with PARP inhibitors and CDK4/6 inhibitors and the
results of those combinations; the filing of an IND application for
CB-280 with the U.S. FDA; clinical and commercial potential of its
product candidates; and Calithera’s ability to fund its clinical
programs. 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 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.
Contact:Jennifer
McNealeyir@Calithera.com650-870-1071
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