Sunesis Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. The company’s major advanced program is QINPREZO (vosaroxin), its product candidate for the potential treatment of acute myeloid leukemia (AML). Vosaroxin is an anticancer quinolone derivative, or AQD. In 2014, the company announced the results of a Phase 3, multi-national, randomized, double-blind, placebo-controlled trial of vosaroxin in combination with cytarabine in patients with relapsed or refractory AML, or the VALOR trial. The company owns worldwide development and commercialization rights to vosaroxin. TAK-280 TAK-580 is a pan-Raf kinase inhibitor with a distinct molecular signature which has exhibited a promising profile. SNS-062 is a potent, non-covalently binding inhibitor of Bruton’s tyrosine kinase (BTK). BTK mediates signaling through the B-cell receptor, which is critical for adhesion, migration, proliferation and survival of normal and malignant B-lineage lymphoid cells. SNS-229 and SNS-510 In January 2014, the company in-licensed a series of selective PDK1 inhibitors from Millennium that were discovered under a research collaboration agreement between Biogen Idec and Sunesis. The company has taken a series of PDK1 inhibitors with confirmed antitumor activity in vitro and in vivo into preclinical development, and in 2014, the company selected two PDK1 inhibitors, SNS-229 and SNS-510, of which it has taken one, SNS-229 into IND-enabling ADME and safety studies. Strategy The company plans to continue to build Sunesis into a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers by: pursuing regulatory approval for vosaroxin as a potential treatment for relapsed or refractory AML in Europe, the United States, and other major markets; leveraging potential partners and distributors to commercialize vosaroxin in selective international markets; establishing vosaroxin as the new standard of care for patients with relapsed or refractory AML; exploring the broader potential of vosaroxin, beyond its pivotal indication, in different patient segments within AML and myelodysplastic syndrome through investigator sponsored trials; investing in additional clinical testing to evaluate vosaroxin for additional AML indications, myelodysplastic syndrome, other hematologic malignancies and solid tumors; leveraging its strong intellectual property protection over vosaroxin to capitalize on its full potential; supporting its multi-kinase inhibitor programs with Millennium in oncology and Biogen Idec MA, Inc. (Biogen Idec) for immunology indications; conducting a phase 1a study in healthy volunteers for its BTK inhibitor, SNS-062; conducting ADME and safety studies with its PDK1 inhibitor, SNS-229 in 2016; and continuing to expand and develop its oncology-focused pipeline through further licensing or collaboration arrangements and research and development. Licensing and Collaboration Agreements In 2003, the company has an agreement with Sumitomo to acquire exclusive worldwide development and marketing rights for vosaroxin. In 2004, the company entered into the original collaboration agreement with Biogen Idec to discover, develop and commercialize small molecule inhibitors of the human protein Raf kinase, including family members Raf-1, A-Raf, B-Raf and C-Raf, collectively Raf, and up to five additional targets that play a role in oncology and immunology indications, such as BTK and PDK1, or the Biogen Idec OCA. In 2013, the company entered into a second amended and restated collaboration agreement with Biogen Idec, or the Biogen Idec 2nd ARCA, which amended and restated the Biogen Idec 1st ARCA, to provide the company with an exclusive worldwide license to develop, manufacture and commercialize SNS-062, a BTK inhibitor synthesized under the Biogen Idec 1st ARCA, solely for oncology indications. In 2014, the company entered into an amended and restated license agreement with Takeda, or the Amended Takeda A
sunesis pharmaceuticals inc
395 Oyster Point Boulevard
South San Francisco, CA 94080
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