- Preliminary data demonstrate that AB122 has properties similar to
those of approved anti-PD-1 antibodies -
HAYWARD, Calif.--(BUSINESS WIRE)--
Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical
company focused on creating innovative cancer immunotherapies, today
announced preliminary data from its ongoing Phase 1 dose-escalation
study of AB122. The data are being presented today during a poster
presentation at the Society for Immunotherapy of Cancer (SITC) Annual
Meeting in Washington, D.C.
“Preclinical data previously demonstrated that AB122 has biological,
pharmacokinetic and pharmacodynamic properties similar to those of the
approved anti-PD-1 antibodies and the dose-escalation data presented
today represent an important step in confirming these results in
patients,” said Joyson Karakunnel, MD, MSc, FACP, Vice President of
Clinical Development at Arcus. “These results support the selection of
240 mg as the AB122 dose for administration every 2 weeks (Q2W); we
continue to enroll patients in the Phase 1 study to identify the
appropriate doses for administration every 3 weeks (Q3W) or every 4
weeks (Q4W).”
“Since Arcus’s inception, we believed it was important to ensure access
to an anti-PD-1 antibody to maximize the value of our internally
discovered product candidates, which guided our decision to in-license
AB122 from WuXi Biologics, one of the leading biologics manufacturing
companies,” said Terry Rosen, Ph.D., Chief Executive Officer at Arcus.
“Our development strategy for AB122 is focused on its development in
combination with our other product candidates, including AB928, our dual
adenosine receptor antagonist, AB680, our small molecule CD73 inhibitor,
and AB154, our anti-TIGIT antibody.”
Design of the Phase 1 Dose-Escalation Study for
AB122
The Phase 1 dose-escalation study for AB122 is designed to evaluate the
safety, immunogenicity, pharmacokinetic, pharmacodynamic and clinical
activity profile of AB122. The Company is evaluating three dosing
regimens with the goal of identifying doses of AB122 that can be
administered Q2W, Q3W or Q4W.
As of the cutoff date of October 5, 2018, 20 patients had been treated:
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For the Q2W dosing regimen, doses of 80 mg (n=3), 240 mg (n=6), and
360 mg (n=1) were evaluated. 240 mg was identified as the recommended
dose for this regimen, based on receptor occupancy data.
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For the Q3W dosing regimen, a dose of 360 mg (n=5) is being evaluated.
This cohort continues to enroll patients with the goal of identifying
a recommended dose for this regimen.
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For the Q4W dosing regimen, a dose of 480 mg (n=5) is being evaluated.
This cohort also continues to enroll patients with the goal of
identifying a recommended dose for this regimen.
Results from the Phase 1 Dose-Escalation Study
As of the data cutoff date:
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The following tumor types were enrolled: ovarian (7), colorectal (3),
endometrial (3), gastroesophageal (2), bladder (1), head and neck (1),
breast (1), non-small cell lung (1), and prostate (1).
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Time on study ranged from 0.8 to 9.9 months.
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AB122 was well tolerated at all doses evaluated. The majority of
treatment emergent adverse events (TEAEs), regardless of causality in
all subjects, were Grade 1/2, the most common of which were fatigue
(55%) and diarrhea and nausea (25% each). Three patients experienced
serious adverse events (SAEs), none of which were considered related
to AB122: Grade 2 lower respiratory tract infection, Grade 2 fever and
Grade 3 elevated liver function tests secondary to cholelithiasis.
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Data from the three patients in the 80 mg Q2W and six patients in the
240 mg Q2W cohorts showed that AB122 achieved full and sustained
receptor occupancy on peripheral blood T cells across all time points
in the majority of patients. These data are consistent with published
data for approved anti-PD-1 antibodies.
-
Of the 16 response-evaluable patients, two patients demonstrated a
reduction in tumor size: a patient with head and neck cancer in the 80
mg Q2W cohort and a patient with ovarian cancer in the 360 mg Q2W
cohort.
-
Disease control rate was 50% in the evaluable patient population.
Stable disease was achieved in patients with colorectal cancer (2),
ovarian cancer (1) and head and neck cancer (1).
Ongoing and Planned Clinical Trials for AB122
Arcus is planning to initiate an expansion cohort which will evaluate
AB122 in non-small cell lung cancer with the objective of confirming
that AB122 has similar clinical activity to that of the approved PD-1
antibodies. AB122 is also being evaluated in combination with AB928, as
well as with AB154, in Phase 1/1b dose-escalation trials.
Details of Arcus’s Poster Presentation is as
Follows:
Title: Preliminary results from an ongoing Phase 1 study of
AB122, an anti-programmed cell death-1 (PD-1) monoclonal antibody, in
patients with advanced solid tumors.
Poster Number: P673;
Abstract ID: 10638
Poster Presentation Hours: Friday,
Nov. 9, from 12:45 – 2:15 pm and 6:30 – 8 pm ET
Poster Hall
Location: Hall E
This poster presentation, as well as the Company’s eight other posters
being presented at SITC, will be available on Arcus’s corporate website
at https://www.arcusbio.com/publications/.
About AB122
AB122 is a fully human IgG4 antibody that potently and selectively
blocks the interaction of PD-1 with its ligands, PD-L1 and PD-L2. The
biochemical, biological and preclinical properties of AB122 have been
shown to be similar to those of the marketed anti-PD-1 antibodies
nivolumab and pembrolizumab. In August 2017, Arcus entered into a
license agreement with WuXi Biologics for an exclusive license to
develop, use, manufacture, and commercialize AB122 worldwide except for
China and five other countries outside of the U.S., Europe and Japan. In
November 2017, dosing was initiated in Australia for the Phase 1 trial
of AB122 in cancer patients. AB122 is also being evaluated in
combination with AB928, the Company’s dual adenosine receptor
antagonist, in a Phase 1/1b dose-escalation trial. Preliminary data from
this trial are expected in the second quarter of 2019. The Company
expects AB122 to form the backbone of many of its intra-portfolio
combinations.
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 is in a Phase 1/1b program to
evaluate AB928 in combination with other agents in multiple tumor types,
and an anti-PD-1 antibody AB122, which is being evaluated in a Phase 1
trial and is being tested in combination with Arcus’s other product
candidates. Arcus’s other programs include AB154, an anti-TIGIT
antibody, which is in a Phase 1 trial to evaluate AB154 as monotherapy
and in combination with AB122, and AB680, a small molecule inhibitor of
CD73, which has entered clinical development. 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 strategy and clinical development plans, 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,
risks associated with preliminary data and the emergence of adverse
events or other undesirable side effects. Risks and uncertainties facing
Arcus are described more fully in Arcus’s quarterly report on Form 10-Q
for the quarter ended September 30, 2018 filed on November 8, 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
Jennifer Jarrett, 510-694-6261
jjarrett@arcusbio.com
or
Nicole
Arndt, 510-284-4728
narndt@arcusbio.com
Source: Arcus Biosciences