NewLink Genetics Corp Announces Data From Investigator-Initiated Phase 2 Study Of NewLink Genetics' HyperAcute Melanoma Immunotherapy

NewLink Genetics Corp announced results from a Phase 2 investigator-initiated study of NewLink's HyperAcute Melanoma immunotherapy product candidate in combination with pegylated interferon (Sylatron, Merck). Twenty-five patients (16 Stage IV patients and nine Stage III patients) with advanced melanoma were treated with 150 million cell injections weekly for 12 weeks in combination with an eight week course of pegylated interferon. Trial endpoints included clinical response, overall safety and correlative findings for observed anti-tumor effect. Twenty-one of 25 patients completed the trial, with four stopping due to progressive disease. HyperAcute Melanoma was well tolerated without significant grade 3 or 4 toxicities associated with the vaccine. By RECIST criteria, of 16 stage IV patients there were two complete responders (CR), two with stable disease and three with no evidence of disease (NED) after resection. Among stage III patients, 3/9 remain disease free and one patient with slowly progressive disease remained alive for more than 30 months. The median overall survival in the study was 29 months, with 50% of the patients surviving for two years and 12/25 (48%) still alive. The anti-alpha-Gal antibody values increased after vaccination in 24/25 patients by up to 100-fold. All evaluable patients seroconverted, developing asymptomatic autoimmune antibodies. Anti-tyrosinase antibodies developed in seven of 23 patients correlating with one CR and one patient NED.