ArQule, Inc., a biopharmaceutical company, engages in the research and development of therapeutics to treat cancers and rare diseases. The company intends to produce drugs that target biological pathways implicated in a range of cancers and certain non-oncology indications. Its clinical stage pipeline consists of four product candidates, all of which are in targeted patient populations. The company’s primary product candidate is tivantinib (ARQ 197), an orally administered, small molecule inhibitor of the c-Met receptor tyrosine kinase (MET) and its biological pathway. MET is a promising target for cancer therapy, based on its multiple roles in cancerous cell proliferation, tumor spread, new blood vessel formation and resistance to certain drug therapies. The company and its partners, Daiichi Sankyo Co., Ltd. (Daiichi Sankyo) and Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin), are implementing a worldwide clinical development program with tivantinib. The company’s primary indication is liver cancer (hepatocellular carcinoma or HCC), and it is conducting two Phase 3 trials with its partners. The company has also completed earlier-stage single agent and combination therapy trials and pre-clinical experiments with tivantinib and other anti-cancer agents that might provide data to support trials in additional indications. The company’s most advanced ongoing clinical trial, the METIV-HCC trial, is a pivotal Phase 3 randomized, double-blind, controlled study of tivantinib as single agent therapy in previously treated patients with MET diagnostic-high, inoperable HCC conducted by Daiichi Sankyo and it. The company has licensed commercial rights to tivantinib for human cancer indications to Daiichi Sankyo in the U.S., Europe, South America and the rest of the world, excluding Japan and certain other Asian countries, where it has licensed commercial rights to Kyowa Hakko Kirin. The company has collaborated with the National Cancer Institute (NCI) through its Cancer Therapy Evaluation Program to explore the clinical potential of tivantinib in various tumor indications. The company’s proprietary pipeline of product candidates is directed toward molecular targets and biological processes with demonstrated roles in the development of both human cancers and rare, non-oncology diseases. These product candidates include ARQ 092, designed to inhibit the AKT serine/threonine kinase; ARQ 087, a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor (FGFR) family; and ARQ 761, a Beta lapachone analog being evaluated in investigator-sponsored testing as a promoter of NQO1-mediated programmed cancer cell necrosis. Strategy The company’s strategy is to focus on the most promising indications within its clinical programs based upon continually generated and updated clinical and pre-clinical data. Its strategy is to build a fully integrated, commercial-stage biotechnology company that discovers, develops, and commercializes safe, innovative, and effective small molecule drugs in the fields of oncology and rare diseases. Patents and Proprietary Rights For its MET program, the company has three issued patents in the U.S. covering the composition of matter of tivantinib and its derivatives, as well as pharmaceutical compositions and methods of use thereof. The U.S. Patent and Trademark Office has determined that the term of the initial patent would be adjusted beyond its normal expiration date of February 2026 to March 2029 (and in addition, there is the possibility of a patent term extension based upon regulatory review) and the second patent would be adjusted beyond its normal expiration date of February 2026 to December 2026. The company has issued patents from the Republic of Korea, the Republic of Singapore, Australia, the People’s Republic of China, the E.U., Japan, Israel, Mexico, New Zealand, the Philippines, Russia, Canada, Hong Kong, Indonesia, India, Malaysia, Norway and South Africa for composition of matter covering tivantinib. It understands that these patents would expire in February 2026. The company also has pending U.S., E.U. and other foreign applications cove
arqule inc (ARQL:NASDAQ GM)
One Wall Street
Burlington, MA 01803
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