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October 31, 2008

Onyvax identifies a biomarker profile that could be predictive of response to cancer vaccines

London, UK – 31 October, 2008: Onyvax Limited, the biotechnology company developing novel cancer therapies, today announced that, in collaboration with the John van Geest Cancer Research Centre (based at Nottingham Trent University, Nottingham UK), researchers have discovered an immunological profile that could be used to predict whether a patient will respond to cancer vaccine therapy. If validated, this profile could be used to streamline the development of cancer vaccines by targeting those patients who may be more likely to respond to the therapy. The data was published on 30 October 2008 at the second ASCO-NCI-EORTC Annual Meeting on Molecular Markers in Cancer in Hollywood, Florida.

Research undertaken as part of an EU FP6 funded programme to discover biomarkers (ENACT: www.enactcancerresearch.org) has found significant differences in pre-treatment immunological biomarkers in patients who responded to vaccination compared to those who didn’t. In the Phase IIa clinical trial, 40% of patients made a statistically significant reduction in PSA velocity (a blood marker for prostate cancer). Prior to vaccination, these patients’ immune cells, when in a resting state, made lower amounts of the pro-inflammatory cytokine interferon-gamma than non-responders. When stimulated in the laboratory, they increased their levels of interferon-gamma but did not produce as much interleukin-5 as non-responders. This profile could predict with over 90% accuracy whether that patient would make a PSA velocity response.

Dr. Anthony Walker, CEO of Onyvax said: "The possibility of predicting whether a patient will respond to a cancer vaccine may allow us to focus our resources on these patients. This would lead to much more efficient drug development, and may give patients the comfort of knowing they have a very good chance of responding to the vaccine. Clearly, all biomarkers need to be prospectively validated, and identifying this signature is a promising first step.”

Previous Phase IIa data for Onyvax-P, published in Clinical Cancer Research, June 15th 2005 edition, showed:

  • significant slowing of PSA rise in 40% patients
  • time to disease progression (i.e. clinical deterioration) took 58 weeks compared to historical experience of 29-30 weeks
  • low-grade side effects typical of standard vaccines including transient flu-like symptoms and redness and swelling at injection sites

Prostate cancer is one of the most prevalent cancers that affects the male population. Each year approximately 410,000 patients are diagnosed with the disease in the seven major markets, of which 250,000 cases are in the United States alone. The incidence of hormone resistant prostate cancer in the seven major markets is over 36,500 patients per annum, with a total patient population of 220,000.

For further information:

Dr Anthony Walker / Robert Johnson
+44 (0)208 682 9494

Financial Dynamics
Julia Philips
+44 (0)20 7831 3113


Notes to editors

About the John van Geest Cancer Research Centre:

The John van Geest Cancer Research Centre is undertakes work into human cancer vaccines and biomarker discovery using “state-of-the-art” technologies in the fields of Tumour Immunology and Vaccine Development, Antigen Discovery & Molecular Genetics, Clinical Proteomics and Bioinformatics with a special focus on Prostate Cancer. The Centre is core-funded by The John and Lucille van Geest Foundation and is based in The School of Science and Technology at Nottingham Trent University.

About Onyvax:

Onyvax Ltd is a biotechnology company developing novel cancer therapies that harness the selective power of the immune system to seek and destroy tumour cells.

Founded in 1998, Onyvax is developing products that use the power of the immune system to treat prostate and other cancers. Onyvax’s lead products are based on combinations of inactivated cell lines that induce immune responses to a broad spectrum of tumour targets. Onyvax-P, a Cell Vaccine for prostate cancer, is the subject of two randomized, double blind, placebo controlled Phase IIb clinical trials, one in Europe, the other in US. For each cancer type, Onyvax generates banks of proprietary cell lines representative of different stages of the disease. The vaccines are manufactured in bulk under standardized conditions.

Onyvax is committed to the commercialization of new therapies that significantly prolong survival while maintaining a high quality of life for cancer patients. The Company is based in London and has collaborations with leading institutions in Europe and the US. Further information on Onyvax can be found at www.onyvax.com


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