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Collaboration to discover an innovative treatment approach for
gastrointestinal stromal tumors (GIST) patients with disease resistant
to current therapies
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KIT mutations drive GIST in approximately 80 percent of patients
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Array to discover novel KIT inhibitor; broad experience in
designing selective kinase inhibitors
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Clovis responsible for preclinical and clinical development as well
as worldwide commercialization of compound
BOULDER, Colo., Jul 16, 2012 (BUSINESS WIRE) --Clovis Oncology, Inc. (Nasdaq: CLVS) and Array BioPharma (Nasdaq: ARRY)
announced today an agreement for the discovery of a novel KIT inhibitor
targeting resistance mutations for the treatment of GIST. GIST is a
gastrointestinal cancer diagnosed each year in more than 12,000 patients
in the US and EU and 2,500 in Japan. Currently approved therapies for
GIST include the tyrosine kinase inhibitors (TKIs) Gleevec® (imatinib),
and Sutent® (sunitinib), typically used first- and second-line
respectively. Each inhibits some KIT mutations, but acquired resistance
due to secondary KIT mutations occurs in the majority of GIST patients,
resulting in disease progression. Patients who present with metastatic
GIST have a five-year survival rate of approximately 50 percent.
Exon 17 resistance mutations are considered the most difficult to treat,
and typically emerge after other TKI therapy in at least 50 percent of
patients with progressive disease. None of the currently-approved
therapies inhibit exon 17 mutations, nor do the current
development-stage drugs targeting GIST. The goal of this collaboration
is to discover a potent, oral inhibitor of KIT mutations, including all
exon 17 resistance mutations.
“Virtually all GIST patients on first-line therapy progress due to the
persistent and resistant nature of the disease,” said Dr. Jonathan
Fletcher, Associate Professor, Harvard Medical School. “Therefore, there
is significant unmet medical need for patients with advanced GIST.
Specifically, we see a need for therapy active against the KIT exon 17
mutations.”
“Array has a proven track record of success in the discovery of novel
drugs and we are very pleased to collaborate with them to identify our
fourth product candidate,” said Patrick J. Mahaffy, president and CEO of
Clovis Oncology. “This program is highly complementary to our current
programs, takes advantage of our experience in developing targeted
therapies with companion diagnostics and represents another cost
effective approach to building our pipeline. If successful, we would
hope to file an IND within three years, which is also well-timed as our
existing pipeline matures.”
“We are delighted to collaborate with Clovis on this challenging cancer
target,” said Ron Squarer, Chief Executive Officer, Array BioPharma.
“With 10 Array-invented drugs currently in Phase 2 clinical development
and vast experience in the structure-based discovery of kinase
inhibitors, we are confident we will create value for Clovis and
ourselves with the ultimate goal of improving treatment for cancer
patients.”
Under the terms of the agreement, Clovis Oncology and Array BioPharma
will collaborate on the discovery of the compound. Clovis will be fully
responsible for all aspects of the pre-clinical and clinical development
and commercialization, including development of a companion diagnostic
to prospectively identify patients with specific KIT mutations.
Financial terms were not disclosed.
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 Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the
discovery, development and commercialization of targeted small-molecule
drugs to treat patients afflicted with cancer and inflammatory diseases.
Array has four core proprietary clinical programs: ARRY-614 for
myelodysplastic syndromes, ARRY-520 for multiple myeloma, ARRY-797 for
pain and ARRY-502 for asthma. In addition, Array has 10 partner-funded
clinical programs including two MEK inhibitors in Phase 2 clinical
trials: selumetinib with AstraZeneca and MEK162 with Novartis. For more
information on Array, please go to www.arraybiopharma.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
research and 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 risks and uncertainties inherent in the
discovery program identifying a suitable candidate compound, the
activities required to move an early stage compound through pre-clinical
and clinical development, actions by regulatory authorities regarding
whether to approve drug applications that may be filed, and the
corresponding development and approval pathways of a companion
diagnostic. 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.
Array BioPharma Inc. Forward-Looking Statement: This press
release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, including statements
about the timing of the announcement of the results of clinical trials
for our proprietary and our partnered programs, the time of the
completion or initiation of further development of our partnered
programs, our potential to earn future milestone and royalty payments
under our collaboration agreements, expectations that events will occur
that will result in greater value for the Company, the potential for the
results of ongoing preclinical and clinical trials to support regulatory
approval or the marketing success of a drug candidate, our ability to
partner our proprietary drug candidates for up-front fees, milestone
and/or royalty payments, our future plans to progress and develop our
proprietary programs and the plans of our collaborators to progress and
develop programs we have licensed to them. These statements involve
significant risks and uncertainties, including those discussed in our
most recent annual report filed on Form 10-K, in our quarterly reports
filed on Form 10-Q, and in other reports filed by Array with the
Securities and Exchange Commission. Because these statements reflect our
current expectations concerning future events, our actual results could
differ materially from those anticipated in these forward-looking
statements as a result of many factors. These factors include, but are
not limited to, our ability to continue to fund and successfully
progress internal research and development efforts and to create
effective, commercially viable drugs; risks associated with our
dependence on our collaborators for the clinical development and
commercialization of our out-licensed drug candidates; the ability of
our collaborators and of Array BioPharma Inc. to meet objectives tied to
milestones and royalties; our ability to effectively and timely conduct
clinical trials in light of increasing costs and difficulties in
locating appropriate trial sites and in enrolling patients who meet the
criteria for certain clinical trials; risks associated with our
dependence on third-party service providers to successfully conduct
clinical trials within and outside the United States; our ability to
achieve and maintain profitability and maintain sufficient cash
resources; the extent to which the pharmaceutical and biotechnology
industries are willing to in-license drug candidates for their product
pipelines and to collaborate with and fund third parties on their drug
discovery activities; our ability to out-license our proprietary
candidates on favorable terms; and our ability to attract and retain
experienced scientists and management. We are providing this information
as of July 16, 2012. We undertake no duty to update any forward-looking
statements to reflect the occurrence of events or circumstances after
the date of such statements or of anticipated or unanticipated events
that alter any assumptions underlying such statements.
SOURCE: Clovis Oncology
Clovis Oncology
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna
Burkart, 303-625-5023
bburkart@clovisoncology.com
or
Array
BioPharma
Tricia Haugeto, 303-386-1193
thaugeto@arraybiopharma.com
