AMES, Iowa, June 1, 2012 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (Nasdaq:NLNK - News) today announced results from a Phase 2 investigator-initiated study of NewLink's HyperAcute(R) Melanoma immunotherapy product candidate in combination with pegylated interferon (Sylatron, Merck). The data were published in an abstract (No:e19008) at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting being held in Chicago, IL. This is in advance of presentations scheduled for Monday, June 4th at ASCO regarding NewLink's HyperAcute Pancreas (algenpantucel-L) and HyperAcute Lung (tergenpumatucel-L) immunotherapy product candidates and IDO pathway inhibitor, NLG8189 (D-1mT) product candidate.

"Patients with metastatic melanoma have a poor outcome. We find it very encouraging that all of the patients in this study had immune responses to HyperAcute Melanoma including several patients who either had a complete objective response or have continued disease free survival after the resection of Stage III or IV disease," said Dr. Adam Riker, senior author of the abstract entitled, "Final results of a phase II immunotherapy trial for stage III and IV melanoma patients." "This promising data warrants further studies especially considering that this study employed only a short 12-week course of therapy at a relatively low dosage."

Phase 2 Study Design

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.

Study Findings

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. Vitiligo developed in 4/25 patients, correlating with two complete responses and two patients stable continuing with no evidence of disease.

"The presence of vitiligo and durable complete responses provide further evidence for clinical activity of HyperAcute Melanoma ," said Dr. Nicholas Vahanian, President and Chief Medical Officer of NewLink Genetics and added "We look forward to further evaluating our HyperAcute Melanoma immunotherapy in combination with recently approved anti-melanoma agents in additional advanced clinical studies."

"We believe that lessons we are learning from trials employing our proprietary HyperAcute technology in patients with lung and pancreatic cancer can be incorporated into improved study designs for patients with melanoma as we attempt to build upon these initial provocative clinical findings," stated Dr. Charles Link, CEO and Chief Scientific Officer of NewLink Genetics.

About HyperAcute Melanoma

New Link Genetics' HyperAcute Melanoma product candidate consists of a group of three allogeneic melanoma tumor cell lines that were modified to express the gene that makes alpha-GT. These three cell lines each possess collections of known melanoma antigens so that the immune response they stimulate will provide broad coverage. Each of the modified cell lines is grown separately in large cultures, then harvested, irradiated and packaged. Approximately 50 million cells of each HyperAcute Melanoma cell line are given by intradermal injection with each treatment.

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Data From an Investigator-Initiated Phase 2 Study of NewLink Genetics' HyperAcute(R) Melanoma Immunotherapy Published ...

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