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April 19, 2005

Onyvax-105 Cancer Vaccine Shows Encouraging Clinical Results in Osteosarcoma Patients After Intensive Chemotherapy

London, UK – 19 April 2005: Onyvax Limited, the biotechnology company developing novel cancer therapies, today announced the publication of the Phase I/II clinical trial results for Onyvax-105, the company’s investigational anti-cancer immunotherapy also known as 105AD7, in the British Journal of Cancer. Onyvax-105 was invented by a team led by Professor Lindy Durrant at the University of Nottingham with support from Cancer Research UK. The results show that the majority of patients receiving intensive chemotherapy for osteosarcoma can nevertheless mount an immune response to a cancer vaccine approach. Two patients remain free of disease more than 4 yrs after enrolment on the clinical trial, suggesting possible benefit in a small number of cases.

The trial was co-ordinated by the UK Children’s Cancer Study Group and Cancer Research UK, with Dr Kathy Pritchard-Jones of the Institute of Cancer Research & Royal Marsden Hospital in London as principal investigator. 31 pediatric and young adult patients diagnosed with high grade osteosarcoma who had completed current best standard therapy for their condition were recruited. Although the trial was designed to assess feasibility of immunotherapy in this group of patients rather than anti-tumor efficacy, two patients showed unusual clinical courses and remain free of their tumours more than 4 years later.

Professor Pritchard-Jones, Professor of Childhood Cancer Biology and Honorary Consultant in Paediatric Oncology at the Royal Marsden Hospital & Institute of Cancer Research in London and principal investigator of the study, said: “This group of patients have limited treatment options and a very poor prognosis. We were pleased to see a high percentage of patients developing immune responses to Onyvax-105, confirming that an immunomodulatory approach is feasible in combination with the intensive chemotherapy that these children and young adults require. Moreover, it is very unexpected for any patients at this stage of the disease to remain free of recurrent disease for long. The vaccine may be responsible for this effect and the product should be studied in randomised trials designed to assess efficacy.”

Commenting on the results, Professor Angus Dalgleish, Research Director of Onyvax, said: “Evidence that this product may be effective in a range of tumours is building. CD55, the target of this antibody, is over-expressed on a broad range of cancers including prostate, colorectal, lung, breast as well as osteosarcoma. Tumours express CD55 as part of their defence against immune system attack. By vaccinating with Onyvax-105, that defence is removed and the tumour becomes susceptible to immune destruction. In addition, there is potential that this product may work synergistically with other cancer treatments, including monoclonal antibody therapies such as Herceptin and Rituxan, as well as Onyvax’s Cell Vaccine platform.”


For further information, please contact:

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

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



Notes to Editors:

About the trial and about Onyvax-105:

The clinical trial was conducted as a multi-institution collaborative effort between the UK Children's Cancer STudy Group (UKCCSG) at the University of Leicester, Cancer Research UK and the Cancer Division of MRC Clinical Trials Unit. Patients were treated at four centres across the UK: Royal Marsden Hospital, Surrey, the Middlesex Hospital, London, St James University Hospital, Leeds and the Royal Victoria Infirmary, Newcastle. Onyvax-105 was invented by a team led by Professor Lindy Durrant at the University of Nottingham and was licensed to Onyvax Limited in 1999 from Cancer Research Technology. Onyvax Limited is planning further clinical trials of Onyvax-105 in a range of cancers, including a Phase II clinical trial that will look for signs of synergy with Onyvax-P, the company’s lead product for prostate cancer.

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 1997, Onyvax has two product candidates in clinical trials designed for the treatment of 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 due to enter Phase II/III clinical trials in 2005. 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 standardised conditions. The Phase IIa trial for Onyvax-P was conducted by the Department of Oncology at St George’s Hospital Medical School, London, UK.

Onyvax is committed to the commercialisation 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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