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Jan 9, 2014

Sunesis Eyes Kinase Inhibitors in Development Deals with Biogen Idec, Millennium

  • Sunesis Pharmaceuticals today disclosed it will develop exclusively a pair of preclinical kinase inhibitor collaborations it said were designed to strengthen its hematology franchise. The value of both deals was not disclosed.

    In the first deal, Sunesis obtained global commercial rights from Biogen Idec to a selective noncovalently binding oral inhibitor of BTK (Bruton's tyrosine kinase) that the companies believe may hold potential as a treatment for B-cell malignancies and other blood cancers. Sunesis said it anticipates filing an IND application for the compound, called SNS-062, with the FDA in about a year to begin human clinical trials.

    In the other transaction, Sunesis licensed from Millennium: The Takeda Oncology Company global commercial rights to several potential first-in-class, preclinical inhibitors of the novel target PDK1 (phosphoinositide-dependent kinase-1), with the companies reasoning that PDK1 inhibitors can enhance survival and invasion signaling in both hematologic and solid tumor malignancies. Sunesis anticipates selecting a lead PDK1 development candidate this year to take into IND-enabling studies.

    "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," Adam R. Craig, M.D., Ph.D., Sunesis evp of development and CMO, said in a statement. "The PDK1 program may yield a first-in-class compound, while SNS-062, as a distinct, noncovalently 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."

    Both BTK and PDK1 programs were originally under an earlier collaboration by Biogen Idec and Sunesis. Millennium bought and exclusively licensed the PDK1 program along with a program for developing MLN2480, a pan-RAF inhibitor currently in the maximum tolerated dose cohort expansion stage of a Millennium Phase I dose-escalation study.

    Sunesis said it anticipates only modest incremental expense associated with advancing both programs in 2014.

    "These programs represent an exciting expansion of Sunesis' pipeline which, with vosaroxin, provide the opportunity to create a leading hematology franchise," Sunesis CEO Daniel Swisher said. "Taken together with vosaroxin, our wholly owned late-stage program, these efforts are expected to yield a number of important corporate milestones in the upcoming quarters.”

    Those milestones, he said, include a Q2 readout of the Phase III VALOR trial of vosaroxin in first relapsed or refractory acute myeloid leukemia.



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