Clinical Data from NewLink Genetics' HyperAcute Prostate Cancer Immunotherapy Published in Journal of Immunotherapy

AMES, Iowa, Dec. 13, 2012 /PRNewswire/ --NewLink Genetics Corporation (NLNK) today announced that the results of a Phase 1 dose escalation study with its proprietary HyperAcute Prostate Cancer Immunotherapy were published in the Journal of Immunotherapy. The article, entitled "Cellular Immunotherapy Study of Prostate Cancer Patients and Resulting IgG Responses to Peptide Epitopes Predicted From Prostate Tumor-associated Autoantigens," is featured in the current edition of the Journal.

The study was conducted at the University of Nebraska Medical Center and included eight patients. Patients were scheduled to receive a priming dose on day one, followed by eleven boost doses every two weeks and patients received up to 12 intradermal vaccinations at doses ranging from 30 million to 500 million cells per injection. Patients were tested for safety, immunological and clinical responses arising after immunotherapy.

The study demonstrated that the immunotherapy was safe, and that the first immunization differentially increased the anti-alphaGal IgG response in all patients compared with baseline levels. These data indicated that administration of HyperAcute-Prostate immunotherapy increases the immune response against alphaGal epitopes, demonstrating the immunogenicity of the vaccine in prostate cancer patients.

The patients that received the highest dose of immunotherapy developed antibody responses against prostate tumor-associated antigens that were not seen in a control group of untreated volunteers. Data demonstrated that 37.5 percent (3/8) of patients responded with Prostate Specific Antigen (PSA) level stabilization for more than 100 days.

The adverse events data reported in this publication confirm the safety of this immunotherapy, consistent with previous studies on the safety of alpha-Gal-expressing allogeneic vaccines (HyperAcute immunotherapy) in the treatment of lung, melanoma and pancreatic cancers. Median overall survival for the study was 25.1 months with one patient with bone metastases surviving for more than 70 months.

"The favorable safety profile of this agent combined with evidence of vaccine induced immunologic responses in patients clearly suggests this therapy should be studied in a large controlled trial," said Dr. George P. Hemstreet, III, University of Nebraska Medical Center, the Principal Investigator for the study.

NewLink Genetics is currently evaluating its lead immunotherapy product candidate algenpantucel-L (HyperAcute-Pancreas) in a Phase 3 clinical trial in surgically-resected pancreatic cancer patients.

About HyperAcute Prostate Cancer Immunotherapy

NewLink's HyperAcute Prostate Cancer immunotherapy product candidate consists of two allogeneic prostate cancer tumor cell lines modified to express alpha-Gal. These cell lines were chosen to provide a broad coverage of prostate cancer antigens. Each of the modified cell lines is grown in large cultures, harvested, packaged and irradiated. Each of the two vaccine components was administered separately.

About Prostate Cancer

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Clinical Data from NewLink Genetics' HyperAcute Prostate Cancer Immunotherapy Published in Journal of Immunotherapy