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Oxford Biomedica Announces Publication of TroVax(R) Phase III Analyses in Cancer Immunology, Immunotherapy

March 15, 2011

OXFORD, England, March 15, 2011 /PRNewswire-FirstCall/ –

– Immune Response Surrogate Algorithm Shownto be a Significant Predictor
of Clinical Benefit

Oxford BioMedica plc (“Oxford BioMedica” or “the Company”) (LSE: OXB), a
leading gene therapy company, today announces that further analyses of the
TroVax(R) Renal Immunotherapy Survival Trial (“TRIST”), a randomised,
double-blind, placebo-controlled Phase III study, have been accepted for
publication in Cancer Immunology, Immunotherapy, the official journal of the
Association for Cancer Immunotherapy.

The online publication of the article, entitled “MVA-5T4-induced immune
responses are an early marker of efficacy in renal cancer patients”,can be
accessed at: http://www.springerlink.com/content/b54126121tm63152. TroVax(R)
(MVA-5T4) is a therapeutic cancer vaccine designed to stimulate the immune
system to destroy cancerous cells expressing the 5T4 tumour antigen which is
broadly distributed throughout a wide range of solid tumours.

The Phase III TRIST results, published in Clinical Cancer Research in
November 2010, confirmed the association between a high 5T4 antibody response
and enhanced survival in patients treated with TroVax(R). Using data from the
TRIST study, Oxford BioMedica identified analgorithm (the “Immune Response
Surrogate”; IRS)for predicting thequantitative 5T4 antibody response induced
by TroVax(R) in order to identify those patients who are most likely to mount
a strong 5T4 antibody response before receiving TroVax(R).The IRS is a
combination of three baseline (pre-treatment) blood parameters which can be
measured using ablood test; 5T4 antibody levels, haemoglobin and haematocrit
(the proportion of blood volume occupied by red blood cells).

When applied to the TRIST results, the IRS showed a significant
correlation between the 5T4 antibody response, induced following vaccination
with TroVax(R), and treatment benefit, i.e. patients with higher IRS values
who were treated with TroVax(R) survived longer than patients in the placebo
group with the same IRS values.Importantly, the IRS was also associated with
5T4 antibody response and survival when applied to an independent dataset
derived from the ninehistoric Phase I and II studies of TroVax(R) in patients
with renal, colorectal and prostate cancer, implying that the IRS could
potentially be applied to multiple cancer types.

The IRS will beused inall future TroVax(R)clinical trials including the
current Phase II study in hormone refractory prostate cancer, in addition to
the planned sponsored Phase II studies in mesothelioma, colorectal and
ovarian cancers expected to start in 2011. Based on the typical blood
profiles of patients with these cancer indications, it is expected that the
IRS will predict that the majority of these patient populations may benefit
from TroVax(R).

Stuart Naylor, Chief Scientific Officer of Oxford BioMedica, said: “Few
immunotherapy treatmentshave demonstrated a direct link between the predicted
mode of action and clinical benefit. TroVax(R) stands apart as a cancer
vaccine that elicits a strong and readily definable immune response. The IRS
will allow us to target a more responsive patient population and we are
confident that this novel biomarker will be further validated by results from
our current Phase II clinical development programme for TroVax(R).”

Notes to editors

1. Oxford BioMedica(R)

Oxford BioMedica plc (LSE: OXB) is a biopharmaceutical company developing
innovative gene-based medicines and therapeutic vaccines that aim to improve
the lives of patients with high unmet medical needs. The Company’s technology
platform includes a highly efficient LentiVector(R) gene delivery system,
which has specific advantages for targeting diseases of the central nervous
system and the eye; and a unique tumour antigen (5T4), which is an ideal
target for anti-cancer therapy. Through in-house and collaborative research,
Oxford BioMedica has a broad pipeline and its partners include
sanofi-aventis, Sigma-Aldrich and Pfizer. Further information is available at
http://www.oxfordbiomedica.co.uk.

2. TroVax(R)

TroVax(R) is Oxford BioMedica’s therapeutic cancer vaccine which is
designed to stimulate an anti-cancer immune response and has potential
application in most solid tumour types. TroVax(R) targets the tumour antigen
5T4, which is broadly distributed throughout a wide range of solid tumours.
The presence of 5T4 is correlated with poor prognosis. The product consists
of a Modified Vaccinia Ankara vector, which delivers the gene for 5T4 and
stimulates a patient’s body to produce an anti-5T4 immune response. This
immune response destroys tumour cells carrying the 5T4 antigen.

3. Cancer Immunology, Immunotherapy

Cancer Immunology, Immunotherapy keeps readers informed of the latest
research results in the fields of oncology and immunology. The scope of the
journal has broadened to include more of the progress being made in the areas
of biology concerned with biological response modifiers which keeps readers
up to date on the latest advances in the understanding of tumour-host
interactions.The journal publishes short editorials including “position
papers,” general reviews, original articles, and short communications,
providing a forum for the most current experimental and clinical advances in
tumour immunology. Cancer Immunology, Immunotherapy is the official journal
of the Association for Cancer Immunotherapy.

    For further information, please contact:

    Oxford BioMedica plc:
    Tel: +44(0)1865-783-000
    Lara Mott, Head of Corporate Communications

    Media Enquiries:
    Emma Thompson/Amber Bielecka/Katja Toon
    Tel: +44(0)20-7920-2342
    M:Communications

SOURCE Oxford Biomedica Plc


Source: newswire



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