– IPI-549 with AB928 and AB122 in Triple
Negative Breast Cancer and Ovarian Cancer –
– IPI-549 with AB928 and Chemotherapy in
Triple Negative Breast Cancer and Ovarian Cancer –
Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage
biopharmaceutical company focused on creating innovative cancer
immunotherapies, and Infinity Pharmaceuticals,
Inc. (NASDAQ:INFI), a clinical-stage biopharmaceutical company
developing IPI-549, a first-in-class immuno-oncology product
candidate that selectively inhibits phosphoinositide-3-kinase gamma
(PI3K-gamma), today announced that they have entered into a
clinical collaboration to evaluate two triple combination therapies
in selected tumor types which typically show minimal response to
checkpoint inhibition monotherapy.
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The collaboration will evaluate IPI-549 in combination with
AB928, Arcus’s dual adenosine receptor antagonist, and AB122,
Arcus’s anti-PD-1 antibody, as well as IPI-549 in combination with
AB928 and chemotherapy in patients with triple negative breast
cancer (TNBC) or ovarian cancer in four separate cohorts. These
four cohorts will be incorporated into Arcus’s recently initiated
Phase 1/1b trial to evaluate AB928 combinations in TNBC and ovarian
cancer. As both macrophages and high adenosine levels are believed
to play critical roles in creating a highly immune-suppressive
tumor microenvironment in TNBC and ovarian cancer, the triple
combinations being evaluated could represent a promising approach
to treating these tumor types. By intervening in multiple
mechanisms that mediate immuno-suppression, the companies hope to
address two tumor types that lack effective therapies, particularly
in later lines of treatment.
“This partnership with Infinity is important as, for the first
time, we will be investigating the potential for the triple
combination of a selective PI3K-gamma inhibitor, a dual adenosine
receptor antagonist, and either a PD-1 inhibitor or chemotherapy to
effectively treat patients with triple negative breast cancer or
ovarian cancer,” said Terry Rosen, Ph.D., Chief Executive Officer
of Arcus Biosciences. “This collaboration also allows us to expand
the number of promising combinations with strong biological
rationale that we plan to evaluate in our recently initiated Phase
1/1b trial for AB928. Arcus has carefully considered which
immuno-oncology therapies can best target immune suppressive
macrophages and has concluded that selective inhibition of
PI3K-gamma is a fundamental mechanism for reprogramming macrophages
from a pro-tumor to an anti-tumor function.”
“This collaboration with Arcus Biosciences enables an important
expansion of our clinical development of IPI-549, investigating
IPI-549 in triple-combination therapy with other important
immuno-oncology agents as well as with chemotherapy,” said Adelene
Perkins, Chief Executive Officer and Chair of Infinity
Pharmaceuticals. “Combining these agents may result in enhanced
reduction of pro-tumor immune suppression and increased anti-tumor
immune activation. We look forward to working with the terrific
team at Arcus in investigating these triple-combination therapies
as potentially new treatment options for patients with cancers that
are not adequately addressed by existing therapies.”
Under the terms of the agreement, Infinity and Arcus will share
equally expenses related to the four triple-combination cohorts to
evaluate the safety and activity of IPI-549 + AB928 + AB122 and
IPI-549 + AB928 + chemotherapy. Each of the four triple-combination
cohorts will enroll approximately 15 patients. Topline data from
these studies are expected in 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 IPI-549 and the Ongoing Phase 1/1b Study
IPI-549 is an investigational first-in-class, oral,
immuno-oncology product candidate targeting tumor-associated
myeloid cells through selective phosphoinositide-3-kinase-gamma
(PI3K-gamma) inhibition, thereby reducing pro-tumor macrophage
function and increasing anti-tumor macrophage function. In
preclinical studies, IPI-549 demonstrated the ability to reprogram
macrophages from a pro-tumor (M2), immune-suppressive function, to
an anti-tumor (M1) immune-activating function and enhance the
activity of, and overcome resistance to, checkpoint inhibitors.i
ii As such, IPI-549 may have the potential to treat a broad
range of solid tumors and represents a potentially additive or
synergistic approach to restoring anti-tumor immunity in
combination with other immunotherapies such as checkpoint
inhibitors.
The ongoing Phase 1/1b study being conducted by Infinity is
designed to evaluate the safety, tolerability, activity,
pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy
and in combination with Opdivo® in approximately 200 patients
with advanced solid tumors.iii The study includes monotherapy
and combination dose-escalation components, in addition to
monotherapy expansion and combination expansion components. The
monotherapy dose-escalation and expansion components are complete.
The combination dose-escalation component is also complete, and
combination expansion cohorts are enrolling.
The combination expansion component of the study includes
multiple cohorts designed to evaluate IPI-549 in patients with
specific types of cancer, including patients with non-small cell
lung cancer (NSCLC), melanoma and head and neck cancer whose tumors
show initial resistance or initially respond to but subsequently
develop resistance to immune checkpoint blockade therapy. The
combination expansion component also includes a cohort of patients
with triple negative breast cancer (TNBC) who have not been
previously treated with immune checkpoint blockade therapy, a
cohort of patients with mesothelioma, a cohort of patients with
adrenocortical carcinoma and a cohort of patients with high
baseline blood levels of MDSCs.
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.
About Infinity Pharmaceuticals
Infinity is an innovative biopharmaceutical company dedicated to
advancing novel cancer treatments. Infinity is advancing IPI-549, a
potentially transformative immuno-oncology approach that aims to
reprogram tumor-associated macrophages by selectively inhibiting
PI3K-gamma. A Phase 1/1b study in approximately 200 patients with
advanced solid tumors is ongoing. For more information on Infinity,
please refer to Infinity's website at www.infi.com.
Arcus 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, the potential of the
triple combination therapies in TNBC and ovarian cancers and
timeline for topline data, 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 the ability to
demonstrate safety and activity of these triple combinations in the
four cohorts. 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.
Infinity Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Such forward-looking statements include those regarding the
therapeutic potential of PI3K-gamma selective inhibition and
IPI-549, alone and in combination with one or more of Opdivo,
AB928, AB122, and chemotherapy, and plans to report topline data
from the triple combination studies. Management’s expectations and
such forward-looking statements are subject to numerous important
factors, risks and uncertainties that may cause actual events or
results to differ materially from the company's current
expectations, including the risks described under the caption "Risk
Factors" included in Infinity's quarterly report on Form 10-Q filed
with the Securities and Exchange Commission (SEC) on May
8, 2018, and other filings filed by Infinity with the SEC. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Infinity expressly disclaims any
obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise.
OPDIVO® is a registered trademark of Bristol-Myers
Squibb.
i Kaneda, M., Messer, K., Ralainirina, N., Li, H., et al. PI3Kγ
is a molecular switch that controls immune
suppression. Nature, 2016 Nov;539:437–442.
ii De Henau, O., Rausch, M., Winkler, D., Campesato, L., et
al. Overcoming resistance to checkpoint blockade therapy by
targeting PI3Kγ in myeloid cells. Nature, 2016
Nov;539:443-447.
iii www.clinicaltrials.gov, NCT02637531.
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version on businesswire.com: https://www.businesswire.com/news/home/20180626005514/en/
Arcus Biosciences Contacts:Jennifer Jarrett,
510-694-6261jjarrett@arcusbio.comorNicole Arndt,
510-284-4728narndt@arcusbio.comorInfinity Pharmaceuticals
Contact:Stern Investor Relations, Inc.Daniella Funaro,
212-362-1200daniella@sternir.com
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