Delivering on our Promise
Our experienced cancer drug development organization is committed to advancing our pipeline of new oncology therapeutics for the potential treatment of solid and hematologic cancers. Our most advanced program is QINPREZO (vosaroxin), our product candidate for the potential treatment of acute myeloid leukemia (AML). Vosaroxin is an anticancer quinolone derivative, or AQD — a class of compounds that has not been used previously for the treatment of cancer.
Vosaroxin is currently being evaluated in patients with relapsed or refractory AML, frontline AML and myelodysplastic syndrome (MDS) and MDS in patients who have failed frontline treatment with hypomethylating agents. In October 2014, we announced the results from our Phase 3, multi-national, randomized, double-blind, placebo-controlled, pivotal VALOR (Vosaroxin and Ara-C combination evaluating Overall survival in Relapsed/refractory AML) trial. VALOR was designed to evaluate the effect of vosaroxin in combination with cytarabine on overall survival as compared to placebo in combination with cytarabine. The trial was conducted at 124 study sites in 15 countries. Patients treated with vosaroxin achieved increased overall survival compared to those treated with placebo (7.5 months vs 6.1 months, HR=0.87), the primary endpoint, but this difference did not achieve statistical significance (p=0.06). The complete remission (CR) rate, the sole secondary efficacy endpoint in the trial, did demonstrate a significant difference for the vosaroxin combination arm (30.1% vs 16.3%, p < 0.0001). Detailed results of the VALOR trial were presented in the "Late Breaking Abstracts" session of the American Society of Hematology (ASH) Annual Meeting in December 2014.
In November 2014, based on results of the trial, we submitted a letter of intent to the European Medicines Agency (EMA) describing our intention to file a marketing authorization application (MAA) for marketing authorization of vosaroxin plus cytarabine for the treatment of relapsed or refractory AML. In June 2015, we met separately with our Rapporteur and Co-Rapporteur, who are two appointed members of the EMA's Committee of Human Medicinal Products. Based upon feedback from these meetings, we plan to file an MAA with the EMA as soon as practicable. In July 2015, we met with the U.S. Food and Drug Administration (FDA) to discuss a potential regulatory filing in the United States. Based upon the meeting, the FDA recommended that we provide additional clinical evidence prior to any regulatory filing in the U.S. As a result, we will evaluate regulatory and clinical strategies with the goal of gaining future marketing approval in the U.S.
We own worldwide development and commercialization rights to vosaroxin. In 2009, vosaroxin received orphan drug designation for the potential treatment of AML from the FDA and in 2012, the European Commission granted orphan drug designation to vosaroxin for the treatment of AML, which may provide for 10 years of marketing exclusivity in all member countries of the European Union following product approval for this indication in Europe. In 2011, the FDA granted fast track designation to vosaroxin for the potential treatment of relapsed or refractory AML in combination with cytarabine.
In January 2014, we announced the expansion of our oncology franchise through separate global licensing agreements for two preclinical kinase inhibitor programs. The first agreement, with Biogen Idec MA, Inc. (Biogen Idec) is for global commercial rights to SNS-062, a selective non-covalently binding oral inhibitor of Bruton's tyrosine kinase (BTK).
The second agreement, with Millennium Pharmaceuticals, Inc., a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited (Millennium), is for global commercial rights to several potential first-in-class, pre-clinical inhibitors of the novel target phosphoinositide-dependent kinase-1 (PDK1).
We plan to continue to build Sunesis into a leading biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers by:
- filing an MAA with the EMA as soon as practicable, with the goal of obtaining regulatory approval for vosaroxin as a potential treatment for relapsed or refractory AML in Europe,
- evaluating regulatory and clinical strategies with the goal of gaining future marketing approval for vosaroxin in the U.S. 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 our pivotal indication, in different patient segments within AML and MDS through investigator sponsored studies;
- investing in additional company-sponsored clinical trials to evaluate vosaroxin for additional AML indications, MDS, other hematologic malignancies and solid tumors;
- leveraging our strong intellectual property protection over vosaroxin to realize its full potential;
- supporting our multi-kinase inhibitor programs with Millennium in oncology and Biogen Idec for immunology indications;
- filing a Clinical Trial Authorization (CTA) application with the EMA to support a Phase 1A study for our BTK inhibitor, SNS-062, in healthy volunteers;
- moving at least one of the two selected development candidates from our PDK1 inhibitor program, SNS-229 and SNS-510, into IND-enabling absorption, distribution, metabolism and excretion (ADME) and safety studies; and
- continuing to expand and develop our oncology-focused pipeline through further licensing or collaboration arrangements and research and development.