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.