Sunesis Pharmaceuticals - Inspired to Make a Difference in Cancer Patients Lives.

Vosaroxin Partnering Opportunities

Sunesis is evaluating partnership opportunities to further develop vosaroxin.

Vosaroxin is an anticancer quinolone derivative (AQD). The molecular core of vosaroxin is structurally similar to quinolones and distinct from anthracyclines and anthracenediones. Vosaroxin's anticancer activity results from apoptosis caused exclusively by DNA intercalation, inhibition of topoisomerase II, and cell cycle inhibition in replicating cells.

Vosaroxin is currently being evaluated in patients with frontlineAML in Investigator Sponsored Trials. The Company published results from its sponsored Phase 3, multi-national pivotal VALOR trial in Relapsed/Refractory AML in Lancet Oncology in July 2015. 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.

In July 2015, we met with the U.S. Food and Drug Administration (FDA) to discuss a potential regulatory filing in the United States. In June 2015, we met separately with our Rapporteur and Co-Rapporteur, who are two appointed members of the European Medicines Agency (EMA)'s Committee of Human Medicinal Products. Based upon feedback from these meetings, we filed a Marketing Authorization Application with the EMA in December 2015 Subsequently, both the FDA and EMA have recommended that we provide additional clinical evidence prior to any regulatory filing in the U.S. or further regulatory filings in the EU. As a result, we will evaluate regulatory and clinical strategies with the goal of gaining future marketing approval in both the U.S. and EU.

Results from Sunesis' clinical and nonclinical studies of vosaroxin have been reported at numerous conferences, and these posters and presentations may be found here.