ArQule said today it regained worldwide rights to develop and commercialize the lead compound and other drugs covered under its AKT cancer drug collaboration with Daiichi Sankyo. The reversion of rights followed Daiichi Sankyo terminating a license and co-commercialization agreement for ARQ 092 with ArQule reached in November 2011.
ARQ 092 is a selective AKT inhibitor discovered through technology from the ArQule Kinase Inhibitor Platform (AKIP™). ARQ 092 was the first compound to emerge from the companies’ November 2008 agreement to collaborate on research through AKIP, designed to generate novel, selective, and potent small molecule kinase inhibitors.
Under that agreement, Daiichi Sankyo obtained from ArQule global exclusive rights for development, manufacturing, and marketing of ARQ 092 and other compounds discovered via AKIP. In return, Daiichi Sankyo agreed to pay ArQule $15 million up-front, plus undisclosed payments for research support in the first and second years of the collaboration, undisclosed licensing fees for compounds discovered through the platform technology, milestone payments related to clinical development, regulatory review and sales, and royalty payments.
In results for the fourth quarter of 2012, Daiichi Sankyo management attributed $10 million of a $10.9 million R&D revenue decrease to the ARQ up-front licensing payment of a year earlier, although it also recorded a $2.8 million increase from the ARQ 092 agreement
ARQ 092 is the subject of an ongoing Phase I trial, from which ArQule said it would present “encouraging” data on April 9 at the annual meeting of the American Association for Cancer Research.
AKT, also known as the serine/threonine kinase PKB, represents a potential therapeutic target for several cancers and other diseases since it is believed to mediate a number of signal transduction processes. The AKT signaling pathway plays a role in regulating cell growth, survival, migration, and angiogenesis, activities that are often disrupted in cancer.
ArQule’s lead product is tivantinib (ARQ 197), an oral, selective inhibitor of the c-MET receptor tyrosine kinase that is now in Phase II and Phase III clinical development. In January, ArQule and Daiichi reported only a one-month extension in progression-free survival in a Phase II trial in patients with aggressive colorectal cancer using ARQ 197, irinotecan, and cetuximab compared with the latter two drugs alone (8.3 months vs. 7.3 months). And in October, ARQ 197 delivered improvement in progression-free survival, but not overall survival, in a Phase III trial in patients with non-small cell lung cancer.
In addition to ARQ 092, ArQule’s pipeline also includes 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.