ArQule regains rights to AKT compounds from Daiichi Sankyo
by Jeffrey Bouley  |  Email the author


WOBURN, Mass.—Instead of ending up at the wrong end of an April Fool's Day prank, ArQule Inc. started the month off with regaining worldwide rights for the development and commercialization of compounds covered under its AKT collaboration with Daiichi Sankyo Co. Ltd., including the lead compound emerging from this collaboration, ARQ 092.
ARQ 092 is a selective AKT inhibitor that was discovered through technology from the ArQule Kinase Inhibitor Platform (AKIP) and optimized through a structure-based drug design methodology. The AKT signaling pathway, which plays a role in regulating cell growth, survival, migration and angiogenesis, is frequently dysregulated in cancer.
"Regaining worldwide rights to the AKT program, including the novel oral agent, ARQ 092, adds significant value for ArQule, as it expands our proprietary pipeline in an exciting area of therapeutic development," said Dr. Brian Schwartz, chief medical officer of ArQule, a biotech company focused on researching and developing next-generation, small-molecule cancer therapeutics. "AKT, also known as the serine/threonine kinase PKB, is believed to mediate a number of signal transduction processes and represents a potential therapeutic target for several cancers and other diseases. We look forward to the AACR data presentation from the ongoing Phase I trial with ARQ 092."
That data will be presented at the American Association for Cancer Research (AACR) annual meeting on April 9.
ArQule is regaining its rights to the AKT program and to ARQ 092 pursuant to Daiichi Sankyo's decision to terminate a license and co-commercialization agreement with ArQule dated Nov. 8, 2011.
For Daiichi, the decision to exit this deal may have a lot to do with setbacks related to a previous deal that helped set the stage for teaming up on ARQ 092. In the previous work, both companies had been optimistic about ARQ 197 (tivantinib), ArQule's lead compound, but now recent months have seen some bumps in the road there, with tivantinib producing disappointing data in October 2012 in a Phase III trial involving patients with non-small cell lung cancer when the numbers suggested patients didn't live significantly longer than subjects in the control group. A few months later, in January, the drug fell short of hopes in a mid-stage study involving patients with colorectal cancer.
Tivantinib, which in Phase II and Phase III clinical development, is an oral, selective inhibitor of the c-MET receptor tyrosine kinase. The company's pipeline consists of ARQ 092, designed to inhibit AKT; ARQ 087, designed to inhibit fibroblast growth factor receptor (FGFR); ARQ 621, designed to inhibit the Eg5 kinesin motor protein; and ARQ 736, designed to inhibit the RAF kinases. ArQule's AKIP-based current discovery efforts are focused on the identification of novel kinase inhibitors that are potent, selective and do not compete with ATP (adenosine triphosphate) for binding to the kinase.
Code: E04011301

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