HAYWARD, Calif.--(BUSINESS WIRE)--
Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical
company focused on creating innovative cancer immunotherapies, today
announced that the U.S. Food and Drug Administration (FDA) has cleared
Investigational New Drug (IND) applications for the Company’s two most
advanced product candidates, AB928 and AB122. Clearance of the first IND
for AB928 allows the Company to proceed with its planned Phase 1/1b
trial to evaluate the safety, tolerability and preliminary efficacy of
AB928 in combination with other agents, including AB122 (the Company’s
anti-PD-1 antibody) and chemotherapy, in patients with breast and
gynecologic malignancies. Two additional IND applications will be
submitted this month which, if cleared, will enable the Company to
proceed with trials of AB928 combinations in gastrointestinal
malignancies, non-small cell lung cancer (NSCLC) and renal cell
carcinoma (RCC). In parallel, the Company has been completing the
regulatory process to evaluate the combination of AB928 and AB122 in
patients in Australia and expects to dose its first patient with this
combination shortly.
“We are thrilled to receive our first IND clearances to permit dosing in
patients for AB928, our dual adenosine receptor antagonist, in
combination with other anti-cancer agents,” said Terry Rosen, Ph.D.,
Chief Executive Officer at Arcus. “For our initial Phase 1/1b
combination trials for AB928, we have selected tumor types that we
believe will be most responsive to adenosine 2 receptor antagonism and
combination partners that we expect to be synergistic with this
mechanism, specifically immunogenic cell death (ICD) inducing
chemotherapy and anti-PD-1 therapy. We have designed our Phase 1/1b
program for AB928 to provide us with significant flexibility to open new
arms to evaluate promising combinations and to expand or close existing
arms based on the emerging data. We are extremely pleased to begin
testing in patients the first adenosine 2 receptor antagonist that was
specifically designed to be a therapeutic for cancer.”
The Phase 1/1b program for AB928 will initially evaluate AB928 in
combination with AB122 and with chemotherapy in three tumor-specific
trials. The Phase 1/1b program will begin with a
dose-escalation phase to identify the optimal dose of AB928 to be
combined with fixed doses of AB122 and with each of the three different
ICD-inducing chemotherapy regimens. Once the recommended dose of AB928
for each combination has been selected, the tumor-specific trials will
enroll expansion cohorts to evaluate AB928 in combination with AB122 or
chemotherapy in the following selected tumor types:
-
Breast and Gynecologic Malignancies. This trial will initially
evaluate AB928 in combination with AB122 and with DOXIL® in
triple negative breast cancer and ovarian cancer. The FDA has cleared
the IND application for this trial.
-
Gastrointestinal Malignancies. This trial will initially evaluate
AB928 in combination with AB122 and with mFOLFOX in gastroesophageal
and colorectal cancers. The IND application for this trial will be
submitted this month.
-
Lung Cancer and Renal Cell Carcinoma. This trial will initially
evaluate AB928 in combination with AB122 in NSCLC and RCC as well as
AB928 in combination with a platinum-based chemotherapy regimen in
NSCLC. The trial design will also allow for the exploration of
additional AB928 combinations, including triple combinations, and
AB928 in combination with other anti-PD-1 antibodies. The IND
application for this trial will be submitted this month.
Each trial was designed to allow for the addition of new AB928
combination arms in the future. In the dose-escalation portion of the
trials, the Company will assess evidence of immune engagement to enable
a mechanistic understanding of early clinical responses and will
evaluate the suitability of several potential biomarkers for patient
enrichment in the dose-expansion cohorts and in future trials.
Data from the dose-escalation portion of the Phase 1/1b program are
expected to be available in the first half of 2019.
About AB928
AB928 is an orally bioavailable, highly potent antagonist of the
adenosine 2a and 2b receptors. The activation of these receptors by
adenosine interferes with the activity of key populations of immune
cells and inhibits an optimal anti-tumor immune response. By blocking
these receptors, AB928 has the potential to reverse adenosine-induced
immune suppression within the tumor microenvironment. AB928 was designed
specifically for the oncology setting, with a profile that includes
potent activity in the presence of high concentrations of adenosine and
a minimal shift in potency due to non-specific protein binding, both
essential properties to be efficacious in the tumor microenvironment.
AB928 has other attractive features, including high penetration of tumor
tissue and low penetration through the healthy blood-brain barrier. In a
Phase 1 trial in healthy volunteers, AB928 has been shown to be safe and
well tolerated and to have pharmacokinetic and pharmacodynamic profiles
consistent with a once-daily dosing regimen.
About Arcus Biosciences
Arcus Biosciences is a clinical-stage biopharmaceutical company focused
on creating innovative cancer immunotherapies. Arcus has several
programs targeting important immuno-oncology pathways, including a dual
adenosine receptor antagonist AB928, which will be evaluated in
combination with other agents in multiple tumor types in a Phase 1/1b
program, and an anti-PD-1 antibody, which is being evaluated in a Phase
1 trial and will be tested in combination with Arcus’s other product
candidates. Arcus’s other programs include a small molecule inhibitor of
CD73 and an anti-TIGIT antibody, both of which are in IND-enabling
studies. Arcus has extensive in-house expertise in medicinal chemistry,
immunology, biochemistry, pharmacology and structural biology. For more
information about Arcus Biosciences, please visit www.arcusbio.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements
other than statements of historical facts contained herein, including,
but not limited to, Arcus’s regulatory submission timelines, clinical
development plans and investigations of biomarkers and immune
engagement, are forward-looking statements reflecting the current
beliefs and expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. All
forward-looking statements involve known and unknown risks,
uncertainties and other important factors that may cause Arcus’s actual
results, performance or achievements to differ significantly from those
expressed or implied. Factors that could cause or contribute to such
differences include, but are not limited to, the inherent uncertainty
associated with pharmaceutical product development and clinical trials,
delays in our clinical trials due to difficulties or delays in the
regulatory process, enrolling subjects or manufacturing or supplying
product for such clinical trials, and that the results of biomarker
analyses and immune engagement may be subject to differing
interpretations. Risks and uncertainties facing Arcus are described more
fully in Arcus’s quarterly report on Form 10-Q for the quarter ended
March 31, 2018 filed on May 9, 2018 with the SEC. You are cautioned not
to place undue reliance on the forward-looking statements, which speak
only as of the date of this press release. Arcus disclaims any
obligation or undertaking to update, supplement or revise any
forward-looking statements contained in this press release.
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Arcus Biosciences, Inc.
Jennifer Jarrett, 510-694-6261
jjarrett@arcusbio.com
or
Nicole
Arndt, 510-284-4728
narndt@arcusbio.com
Source: Arcus Biosciences