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
