– Leverages Strata Oncology’s Proprietary Biomarker Technology to
Stratify Patients –
HAYWARD, Calif. and ANN ARBOR, Mich.–(BUSINESS WIRE)–Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical
company focused on creating innovative cancer immunotherapies, and
Strata Oncology, Inc. (“Strata”), a precision oncology company, today
announced that the companies have entered into a clinical development
collaboration utilizing Strata’s precision drug development platform and
proprietary biomarkers to evaluate AB122, Arcus’s clinical-stage
anti-PD-1 antibody, in a basket trial including tumor types that are
generally not responsive to anti-PD-1 therapy.
As part of this partnership, Arcus will gain access to Strata’s drug
development platform, featuring leading capabilities to design and
conduct transformative precision therapy studies. AB122 will be
evaluated across the Strata Precision Oncology Network of trial-ready
health systems that employ the StrataNGSTM test to pre-screen
advanced cancer populations to enable rapid and predictable enrollment
of precision therapy trials. The StrataNGS comprehensive tumor
sequencing test is available to all advanced solid tumor patients
through the Strata Trial (NCT03061305)
to identify potential patients for precision therapy trials and to
evaluate proprietary biomarkers that may predict response to therapies.
Using observational study data, Strata has demonstrated the potential
predictive power of their proprietary biomarkers in multiple settings in
which anti-PD-1 therapies are known to be effective. Arcus and Strata
hope to extend the use of some of these biomarkers to identify patients
who may benefit from AB122 treatment in a basket trial including tumor
types that are generally not responsive to anti-PD-1 therapy.
“We look forward to our clinical collaboration with Strata Oncology,”
said Terry Rosen, Ph.D., Chief Executive Officer of Arcus. “The use of
these proprietary biomarkers and access to the Precision Oncology
Network provide a potential opportunity to identify patient populations
underserved by existing PD-1 therapies. While Arcus’s primary focus is
on developing anti-cancer combination therapies with its potentially
best-in-class small molecule drug candidates, we intend to efficiently
pursue targeted opportunities to bring cost-effective anti-PD-1 therapy
to cancer patients otherwise not benefiting from this therapeutic class.
Even with this new collaboration, combined with our novel pipeline
programs, we continue to expect our existing cash and investments will
be sufficient to fund operations into 2021.”
“Strata is committed to advancing the development of new precision
cancer therapies and we are excited to bring together two talented teams
for this collaboration,” commented Dan Rhodes, Ph.D., Co-founder and
Chief Executive Officer of Strata Oncology. “This important effort
leverages Strata’s unique ability to identify novel biomarker-driven
treatment hypotheses using real-world data from the Strata Trial and
rapidly translate those insights into prospective clinical trials across
our Precision Oncology Network. Coupled with Arcus’s significant
expertise in developing cancer immunotherapies, I am confident we will
successfully identify and treat patients who may derive benefit from
AB122 based upon specific biomarkers.”
AB122 is currently being evaluated in an ongoing Phase 1 monotherapy
dose-escalation trial in patients with advanced tumors and ongoing Phase
1/1b combination trials evaluating AB122 in combination with AB928, a
potentially best-in-class adenosine receptor antagonist, and AB122 in
combination with AB154, a novel anti-TIGIT antibody, in patients with
advanced solid tumors.
Under the terms of the agreement, the parties will share development
costs for the clinical collaboration. Strata is eligible to receive $2.5
million upon the achievement of a development milestone, as well as
regulatory and commercial milestones and royalties on U.S. net sales of
AB122 in the biomarker-identified indication. As further consideration,
Arcus issued to Strata restricted shares of its common stock, which are
subject to vesting based upon the achievement of regulatory milestones
within certain timelines.
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 being evaluated in a Phase 1 trial as monotherapy and
in combination with AB122, and AB680, a small-molecule inhibitor of
CD73, which is in a Phase 1 healthy volunteer study. 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.
Arcus Forward-Looking Statements
This press release contains forward-looking statements about Arcus’s
drug development plans, the potential benefits of the collaboration
between Arcus and Strata Oncology and Arcus’s anticipated operating
expenses and capital expenditure requirements. These forward-looking
statements reflect the current beliefs and expectations of management
and are 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, the emergence of
adverse events or other undesirable side effects, delays in clinical
trials due to difficulties or delays in the regulatory process,
enrolling subjects or manufacturing or supplying product for such
clinical trials, and changes in the competitive landscape for our
programs. Risks and uncertainties facing Arcus are described more fully
in Arcus’s most recent Annual Report on Form 10-K and Quarterly Report
on Form 10-Q filed with the U.S. Securities and Exchange Commission. 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.
About Strata Oncology
Strata Oncology is a precision medicine company dedicated to
transforming cancer care by systematizing precision oncology across a
network of health systems and pharma companies. We empower health
systems to deliver a cost-effective, system-wide precision oncology
program, one that integrates cutting-edge molecular profiling and
precision therapy trials with routine care, so that all advanced cancer
patients have the opportunity to benefit. This large network of
trial-ready health systems provides a mechanism to rapidly and
predictably enroll precision therapy trials. For more information, visit www.strataoncology.com.
Contacts
For Arcus Biosciences
Katherine Bock
(415) 533-5670
kbock@arcusbio.com
Nicole Arndt
(510) 284-4728
narndt@arcusbio.com
For Strata Oncology
Terri Clevenger
(203) 856-4326
Terri.clevenger@icrinc.com