BOULDER, Colo.--(BUSINESS WIRE)--Oct. 21, 2013--
Clovis Oncology (NASDAQ: CLVS) announced today that the Company signed
an agreement with QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA)
to develop a companion diagnostic test to identify the T790M resistance
mutation in patients with epidermal growth factor receptor (EGFR) driven
non-small cell lung cancer (NSCLC) for CO-1686.
The diagnostic will build on QIAGEN’s therascreen®
EGFR RGQ PCR Kit, which was approved by the U.S. Food and Drug
Administration (FDA) in July 2013 as a companion diagnostic used in the
treatment of metastatic NSCLC in patients whose tumors have certain EGFR
mutations. Analytical performance of the therascreen EGFR
test has been established for 21 EGFR
mutations, including the most prevalent resistance mutation (T790M).
Terms of the agreement were not disclosed.
“As we continue development of CO-1686 for patients with mutant
EGFR-driven non-small cell lung cancer, we are pleased to collaborate
with QIAGEN for the development of a companion diagnostic for CO-1686,”
said Patrick J. Mahaffy, President and CEO of Clovis Oncology.
“Importantly, QIAGEN’s test is already FDA approved to reliably and
accurately detect EGFR mutations, including T790M, which complements our
accelerated plan for CO-1686 clinical development by potentially
allowing for a supplemental premarket approval (PMA) filing.”
“We are pleased that Clovis has selected the therascreen EGFR
test as its companion diagnostic solution of choice for CO-1686,” said
Peer M. Schatz, QIAGEN’s Chief Executive Officer. “The decision provides
further confirmation for the therascreen technology’s leadership
in companion diagnostics. We look forward to working with Clovis to
contributing the benefits of personalized healthcare to all stakeholders
involved: for pathologists, oncologists, payers and – most importantly –
for patients.”
The diagnostic test is now being further developed in parallel with the
clinical development of CO-1686, with the goal of filing a supplemental
PMA application with the FDA in a time frame that would allow for
regulatory approval of the companion diagnostic concurrent with CO-1686
approval. The Company intends to begin using the QIAGEN test in its
Phase II expansion cohorts, the first of which is expected to begin
enrolling in late 2013.
In addition to the collaboration on CO-1686, both partners have signed a
non-exclusive Master Collaboration Agreement which will enable
additional Clovis assets requiring supporting companion diagnostic
assays to be rapidly developed using QIAGEN sample and assay
technologies where appropriate.
About CO-1686
CO-1686 is a novel, oral, targeted covalent (irreversible) inhibitor of
the cancer-causing mutant forms of epidermal growth factor receptor
(EGFR) currently being studied for the treatment of non-small cell lung
cancer (NSCLC). CO-1686 was designed to selectively target both the
initial activating EGFR mutations as well as the T790M resistance
mutation, while sparing wild-type, or “normal” EGFR at anticipated
therapeutic doses. Accordingly, it has the potential to treat NSCLC
patients with EGFR mutations both as a first-line or second-line
treatment with a reduced toxicity profile compared to current EGFR
inhibitor therapies. The Phase I/II study is currently in the dose
escalation phase, being conducted in the U.S., France and Australia.
Following the establishment of an appropriate dose, the Company intends
to study CO-1686 in Phase II expansion cohorts of NSCLC patients with
activating EGFR mutations who have failed initial EGFR-directed therapy
and have developed the T790M resistance mutation as well as NSCLC
treatment-naïve patients with activating EGFR mutations.
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.
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. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks relating
to the business of the company in general, see Clovis Oncology’s Annual
Report on Form 10-K for the year ended December 31, 2012 and its other
reports filed with the Securities and Exchange Commission.
Source: Clovis Oncology, Inc.
Clovis Oncology, Inc.
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna
Burkart, 303-625-5023
bburkart@clovisoncology.com