After a pair of trial setbacks with a separate program from ArQule, Japan-based drugmaker Daiichi Sankyo has decided to jettison an alliance with the Woburn, MA-based drug developer on an early-stage compound known as ARQ 092. ArQule ($ARQL) reported that the company has regained full rights to ARQ 092, an AKT inhibitor, ahead of reporting Phase I data on the compound at a cancer research meeting later this month.
Daiichi had signed on as a collaborator with ArQule for the 092 asset as part of a November 2011 alliance struck during a time of good feelings about the two companies' previous engagement for ArQule's lead drug tivantinib. Yet in the past half-year or so tivantinib (ARQ 197) trials turned in disappointing data, starting in October with a Phase III misfire involving patients with non-small cell lung cancer, showing that patients in the late-stage study on the drug didn't live significantly longer than subjects in the control group. Then in January the Met inhibitor came up short again in a midstage study of colorectal cancer patients.
ArQule, whose stock price has fallen 48% during this tough 6-month stretch, will have to advance 092 without the deeper pockets at Sankyo. Nevertheless, the biotech's brass talked up the perks of full ownership of the candidate, which targets the AKT signaling pathway that goes haywire in cancer cells and aids cellular growth as well as blood vessel formation or angiogenesis. It's another product of ArQule's tech platform for discovering kinase inhibitors and finely tuning the compounds with structure-based design.
"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," Dr. Brian Schwartz, ArQule's medical chief, said in a statement. "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 1 trial with ARQ 092."
ArQule's shares were up nearly 2% to $2.64 as of 11:59 a.m. ET on April 1.
- here's the release