Researchers recently presented data on ArQule’s ARQ 092 at the American Association for Cancer Research (AACR) Annual Meeting held in Washington, D.C. The data revealed that the candidate inhibits the AKT pathway and proved to be quite safe in an ongoing phase I clinical trial.
ARQ 092 is a selective AKT inhibitor, which was invented from the proprietary ArQule Kinase Inhibitor Platform (AKIP). ARQ 092 was tested in patients with a broad range of advanced or metastatic solid tumors, including colorectal, endometrial and neuroendocrine cancers for safety and activity. The researchers will test ARQ 092 for efficacy once they identify the maximum tolerated dose.
We note that ArQule regained its rights from Daiichi Sankyo to the AKT program and to candidate ARQ 092 after the latter decided to terminate the license and co-commercialization agreement. We note that Daiichi Sankyo and ArQule entered into a license agreement for the development of ARQ 092 in Nov 2011.
As per the license agreement, Daiichi Sankyo had exclusive rights for the development, manufacturing and marketing of ARQ 092 on a global basis. In exchange, ArQule received a $10 million upfront payment from Daiichi Sankyo in Nov 2011 along with support for the ongoing phase I trial on ARQ 092.
Apart from ARQ 092, ArQule’s pipeline also includes oncology candidate ARQ 197 (tivantinib).
In Jan 2013, ArQule and partner Daiichi Sankyo initiated a phase III METIV-HCC -- MET-high patients with tivantinib in hepatocellular carcinoma (HCC) -- trial on ARQ 197.
ArQule currently carries a Zacks Rank #3 (Hold). Right now, other companies in the biopharma space such as Gliead Sciences (GILD - Analyst Report), Agenus Inc (AGEN - Snapshot Report) and Biodel Inc (BIOD - Snapshot Report) look better placed with a Zacks Rank #2 (Buy).