Intellikine earned $4 million in a milestone payment from Infinity Pharmaceuticals on the latter’s start of two Phase I trials with IPI-145 (INK1197), an oral inhibitor of phosphoinositide-3 kinase (PI3K) delta and gamma. Inifinity inked an exclusive, global license to the candidate in July 2010 and is developing IPI-145 as part of its alliance with Mundipharma.
PI3K delta and gamma are implicated in hematologic cancers and a range of inflammatory conditions, which will be the main areas of focus for Infinity’s PI3K clinical development program. The firm says IPI-145 represents the only PI3K delta/gamma inhibitor to have started in clinical development.
One of the Phase I trials will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple escalating doses of IPI-145 in healthy adults. The other, open-label dose-escalation study will evaluate the safety, pharmacokinetics, and clinical activity of IPI-145 in patients with advanced hematologic cancers. An expansion phase of this trial will be initiated in patients with selected malignancies once the maximum tolerated dose has been identified.
Infinity’s 2010 agreement with Intellikine covers worldwide rights to IPI-145 and related IP for PI3K-delta and PI3K-gamma inhibitors. Under terms of the agreement Intellikine could receive up to another $471 million in development and commercial milestones plus future sales royalties. The firm also retains an option to pay an option fee at the end of Phase II development and convert its royalty interest in U.S. sales into the right to share in 50% of the profits and losses on U.S. development and commercialization.
Intellikine is focused on the development of small molecule drugs targeting the PI3K/mTOR pathway for treating cancer and other diseases. Lead candidate, INK128, is a TORC1/2 inhibitor, which is expected to start in Phase II studies during early 2012. The Phase I program for INK128 includes studies in advanced solid malignancies, multiple myeloma, and Waldenstrom macroglobulinemia as well as a solid tumor combination study with paclitaxel/trastuzumab.
In September 2011, Intellikine started clinical development with INK1117, an orally available small molecule inhibitor of PI3Kalpha, for the potential treatment of solid tumors. The Phase I study is evaluating INK1117 as a single-agent treatment for patients with advanced malignancies harboring a PIK3CA mutation.