Arcus Biosciences Presents Initial Data from the Phase 1 Dose-Escalation Study of AB122, its anti-PD-1 antibody, at the SITC ...
09 Novembro 2018 - 10:30AM
Business Wire
- Preliminary data demonstrate that AB122 has
properties similar to those of approved anti-PD-1 antibodies -
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:
- 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.
- 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.
- 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:
- 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).
- Time on study ranged from 0.8 to 9.9
months.
- 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.
- 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: 10638Poster Presentation
Hours: Friday, Nov. 9, from 12:45 – 2:15 pm and 6:30 – 8 pm
ETPoster 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 BiosciencesJennifer Jarrett, 510-694-6261jjarrett@arcusbio.comorNicole Arndt,
510-284-4728narndt@arcusbio.com
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