AMES, Iowa, June 4, 2012 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (Nasdaq:NLNK - News) announced its HyperAcute(R) Lung (tergenpantucel-L) immunotherapy will be featured today in a poster presentation (abstract number 2571) at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting being held in Chicago, IL. The abstract entitled "Correlation of interferon-g (IFN) response with survival in a phase II hyperacute (HAL) immunotherapy trial for non-small cell lung cancer (NSCLC)" will be shown in S Hall A2 from 8:00AM to 12:00 PM. The study presented by Dr. John C. Morris, Professor and Director of Thoracic Cancer Division at the University of Cincinnati, demonstrated a direct correlation between immune response and survival in non-small cell lung cancer patients. In addition, patient survival compared favorably to that seen in patients receiving other second-line chemotherapy agents, suggesting encouraging clinical benefit.

"The overall survival data is particularly remarkable when compared to current standard-of-care, which primarily utilizes cytotoxic chemotherapy agents with their associated debilitating side effects," commented Dr. Nick Vahanian, President, Chief Medical Officer, NewLink Genetics.

"These data suggest an intriguing relationship between a patient's immunological response to tergenpumatucel-L and overall survival," said Dr. John C. Morris. He added, "Survival of the late stage patients in this study compares favorably with that seen in approved agents and there is emerging data to suggest that patient response to some of these agents may be enhanced by prior treatment with tergenpumatucel-L."

Phase 1B/2 Study Design

Seventeen patients were treated in the Phase 1 portion of the study and 37 patients were treated in the phase 2 portion. Patients had metastatic or recurrent NSCLC and had failed first-line chemotherapy. Twenty-eight of the 37 phase 2 patients were evaluable for clinical response. All phase 2 patients received 300 million cells per injection every two weeks for up to eight scheduled doses. Serum samples were collected before and after immunization and then at two-month follow-up visits. Peripheral blood mononuclear cells (PBMC) were collected prior to immunization and after the fourth and eighth vaccinations. Response was determined using RECIST criteria.

Results

There were 28 patients in the phase 2 portion of the study evaluable for response. Among these patients median overall survival was 11.3 months. Eight patients (28.5 percent) demonstrated stable disease after 16 weeks of treatment, including one patient that initially progressed and later regressed, surviving over 40 months. Eighteen patients with pre-immunization and post-immunization serum samples were tested for elevations in interferon-gamma response to drug. Eleven of these 18 responded with increased interferon-gamma, and the overall survival of these patients was 21.9 months. The increase in overall survival of patients with increased interferon gamma compared to non-responders was statistically significant with a p-value of 0.044. Six of the 11 responders showed reactivity to CL4-H522, a cellular target not present in HyperAcute Lung, suggesting cross priming to shared antigens.

Safety and Tolerability

No serious adverse events were reported as definitely or probably attributable to HyperAcute Lung. The most frequently observed adverse events attributable to the therapy were skin reactions at the site of injection. These were generally either acute inflammatory reactions or delayed-type hypersensitivity reactions that resolved without intervention in the vast majority of cases.

Dr. Charles Link, CEO and Chairman of NewLink, stated that, "We are gratified that in addition to seeing positive clinical data with our HyperAcute-Lung product candidate, this study provides us with meaningful insight into the fundamental mechanisms by which this class of immunotherapies work."

Visit link:
NewLink Genetics HyperAcute(R) Lung (tergenpumatucel-L) Immunotherapy Demonstrates a Correlation Between Immune ...

Comments are closed.