Foundation Medicine to provide technology and analysis to inform
companion diagnostic development for Clovis’ PARP inhibitor product
CAMBRIDGE, Mass. & BOULDER, Colo.--(BUSINESS WIRE)--Aug. 6, 2012--
Foundation Medicine, Inc. and Clovis Oncology, Inc. (Nasdaq:CLVS)
announced today that they have entered into a diagnostic collaboration.
The goal of the collaboration is to develop an in-vitro diagnostic (IVD)
to identify biomarkers to select cancer patients most likely to respond
to Clovis’ product candidate rucaparib, a poly (ADP-ribose) polymerase
(PARP) inhibitor currently in Phase I/II clinical development.
“We are pleased to collaborate with Foundation Medicine,” said Patrick
J. Mahaffy, president and CEO of Clovis Oncology. “This continues our
commitment to developing targeted therapies with companion diagnostics
to identify the patients most likely to benefit from our therapeutics.
Foundation Medicine’s leadership in next generation sequencing and
genomic analysis make them an ideal partner to work with us on our
Foundation Medicine and Clovis Oncology will analyze the genomic
alterations found in tissue samples from patients to evaluate the
feasibility of developing an IVD method to identify patients who have
tumors more likely to respond to rucaparib.
In particular, the goal of the collaboration is to identify the
additional genetic mutations beyond those in germ-line and somatic BRCA
that are associated with defective DNA repair and may define appropriate
tumor targets for rucaparib. In high-grade serous ovarian cancer, for
example, this study has the potential to increase the percentage of
ovarian cancer patients potentially eligible for rucaparib therapy from
the 15 percent typically found to have germ-line mutations of BRCA to an
estimated 40 to 50 percent who have DNA repair deficiencies caused by
somatic mutations in a variety of genes.
“Foundation Medicine’s core capability is the translation of genomic
insights into clinically actionable information,” said Michael J.
Pellini, M.D., president and CEO of Foundation Medicine. “But even the
most in-depth genomic profile for a patient is only as actionable as the
available and relevant targeted therapies. Therefore, we are working to
help expand the universe of targeted therapeutic options. Clovis
Oncology, a recognized leader in patient-specific oncology drug
development, is an ideal partner in this mission.”
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing and commercializing innovative anti-cancer agents
in the U.S., Europe and additional international markets. Clovis
Oncology targets development programs at specific subsets of cancer
populations, and simultaneously develops diagnostic tools that direct a
compound in development to the population that is most likely to benefit
from its use. Clovis Oncology is headquartered in Boulder, Colorado, and
has additional offices in San Francisco, California and Cambridge, UK.
About Foundation Medicine
Foundation Medicine is a molecular information company dedicated to a
transformation in cancer care in which treatment is informed by a deep
understanding of the genomic changes that contribute to each patient’s
unique cancer. The company’s initial clinical product, FoundationOne™,
is a fully informative genomic profile to identify a patient’s
individual molecular alterations and match them with relevant targeted
therapies and clinical trials. Foundation Medicine’s molecular
information platform aims to improve day-to-day care for patients by
serving the needs of clinicians, academic researchers and drug
developers to help advance the science of molecular medicine in cancer.
For more information, please visit www.foundationmedicine.com.
Clovis Oncology Forward-Looking Statement: To the extent that
statements contained in this press release are not descriptions of
historical facts regarding Clovis Oncology, they 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. Such forward-looking statements involve
substantial risks and uncertainties that could cause our clinical
development programs, future results, performance or achievements to
differ significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include, among
others, the uncertainties inherent in our clinical development programs
for rucaparib, the corresponding development strategies for companion
diagnostics for our product candidates, actions by the FDA, the EMA or
other regulatory authorities regarding whether to approve drug
applications that may be filed, as well as their decisions regarding
drug labeling, and other matters that could affect the availability or
commercial potential of our drug candidates or companion diagnostics,
including competitive developments. Clovis Oncology does not undertake
to update or revise any forward-looking statements. A further
description of risks and uncertainties can be found in Clovis Oncology’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2011
and in its reports on Form 10-Q and Form 8-K.
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Source: Clovis Oncology, Inc.
Pure Communications, Inc.
Sr. Director, Investor Relations
Sr. Director, Investor Relations