Sunesis Pharmaceuticals has expanded its hematology franchise through separate global licensing agreements for two preclinical kinase inhibitor programs.
The first agreement, with Biogen Idec, is for global commercial rights to SNS-062, a potent and selective non-covalently binding oral inhibitor of BTK (Bruton's tyrosine kinase). BTK is a mediator of B-cell receptor signaling integral to the pathogenesis of B-cell malignancies.
With characteristics and activity distinct from in-class compounds, SNS-062 may hold potential as a differentiated treatment for B-cell malignancies and other blood cancers. Sunesis anticipates filing an investigational new drug (IND) application for SNS-062 with the Food and Drug Administration in approximately one year to begin human clinical trials.
The second agreement, with Millennium: The Takeda Oncology Company, is for global commercial rights to several potential first-in class, pre-clinical inhibitors of the novel target PDK1 (phosphoinositide-dependent kinase-1).
PDK1 is a key kinase and mediator of PI3K/AKT signaling, a pathway involved in cell growth, proliferation, differentiation, motility and survival. PDK1 inhibitors are expected to have unique effects on survival and invasion signaling and to be broadly active in both hematologic and solid tumor malignancies. Sunesis anticipates selecting a lead PDK1 development candidate this year to take into IND enabling studies.
Both BTK and PDK1 programs were originally developed under a research collaboration agreement between Biogen Idec and Sunesis.
The PDK1 program was subsequently purchased by and exclusively licensed to Millennium in 2011 along with the more advanced program, MLN2480, a pan-RAF inhibitor currently in the maximum tolerated dose cohort expansion stage of a Millennium Phase 1, multicenter dose escalation study.
SNS-062 and the PDK1 inhibitor will be developed exclusively by Sunesis. Sunesis anticipates only modest incremental expense associated with advancing both programs in 2014.
Sunesis development executive vice president and chief medical officer Dr Adam R Craig noted as key mediators of signaling pathways known to drive a variety of hematologic and solid tumor malignancies, BTK and PDK1 are both compelling targets in the field of oncology.
"Both programs have unique and differentiating features: the PDK1 program may yield a first-in-class compound, while SNS-062, as a distinct, non-covalently binding molecule, may prove clinically effective in settings where other agents, such as in ibrutinib and/or idelalisib, have failed. We look forward to the opportunity to develop these compounds in a variety of oncology indications," Dr Craig added.
