Research Update

Oxford Biomedica PLC
18 December 2003




18 December 2003





                       OXFORD BIOMEDICA ONCOLOGY UPDATE



Oxford, UK: 18 December 2003 - Oxford BioMedica announced today an update on 
recent R&D and corporate development progress within its oncology portfolio.

Highlights:

  • Encouraging initial TroVax(R) Phase II results in colorectal cancer

  • Company's first IND submission for TroVax in renal cancer

  • Cancer Research UK makes regulatory submission to GTAC for TroVax Phase II
    trial

  • Commercial-scale manufacturing agreement for TroVax

  • Wyeth collaboration on anti-tumour antibody meets key milestone

  • Intervet research collaboration on TroVax-VET for cancer in companion
    animals extended to full option to license agreement

  • Positive final results from the second MetXia(R) Phase I/II trial in
    breast cancer

  • MHRA approval for the MetXia Phase I/II trial in pancreatic cancer


TroVax: Encouraging initial Phase II results in colorectal cancer

The Company is reporting initial data from the Phase II study of TroVax in
patients with Stage IV (Dukes' D) colorectal cancer who are receiving
first line chemotherapy of 5-fluorouracil (5-FU) and irinotecan.  A total of
nine patients have been recruited to date. Three of these have been withdrawn
from the trial because of an inability to withstand the chemotherapy. The
remaining six patients are partway through their TroVax immunisation regime and
have shown no adverse effects that can be attributed to TroVax.

Although these patients have not completed their course of immunisations, the
Company is encouraged by the fact that anti-tumour immune responses have been
mounted. Further immunisations are expected to increase this response.
Furthermore, T-cell (CD4 and CD8) counts, which are indicators of immune
competence, have not been significantly diminished by the chemotherapy;
supporting the notion that immunotherapy alongside chemotherapy may be a
feasible strategy.

Recruitment should be complete by Q1 2004 and further data will be reported with
the Company's full year results. Recruitment for the second Phase II
study, in Stage IV colorectal cancer patients receiving the chemotherapy
combination of 5-FU and oxaliplatin, is underway and initial data will be
available in Q2 2004.

TroVax: First IND submission for Phase II trial in renal cancer

The Company submitted its first IND application to the US FDA on 3 December
2003. The application is for a Phase II trial of TroVax in patients with
metastatic renal cancer. There are about 30,000 cases of metastatic renal cancer
in the US. Currently the standard of care in many US hospitals, after resection
of the primary tumour, is IL2 and this has been shown to have some benefit.
Given that IL2 is known to enhance immune responses, this suggests that the
tumours may be responsive to immunological strategies. The rationale for this
trial is that the immune response produced by TroVax may halt or delay the
progression of metastases so increasing survival beyond the current median of 13
months.

There is a great need for additional therapies for renal cancer and the
regulatory strategy will involve seeking fast track approval and opening
discussions about product registration if early data are compelling. The
endpoints will be immune responses, tumour responses, time to disease
progression and survival. The renal cancer trial will involve 30 patients
initially and will be run at the Columbia Hospital, NY although additional NCI
groups may be included in the future to increase the rate of patient
recruitment. This trial has already been approved by the US Recombinant Advisory
Committee (RAC) and has been the subject of a successful pre-IND meeting with
the FDA. A response from the FDA is expected in early January.

TroVax: Cancer Research UK makes regulatory submission for Phase II trial

Cancer Research UK has submitted the trial protocol for a Phase II trial with
TroVax in colorectal cancer to the UK Gene Therapy Advisory Committee and a
response is expected by 22 December 2003. Oxford BioMedica announced, in August
2003, that Cancer Research UK had agreed to conduct and sponsor an open label
Phase II trial with TroVax, in colorectal cancer patients who have liver
metastases. The decision by Cancer Research UK followed extensive review of the
successful Phase I/II data of TroVax in colorectal cancer patients.

The patient population in the trial will comprise twenty Stage IV colorectal
cancer patients who are to undergo surgery for resectable liver metastases.
Patients will receive injections of TroVax followed by surgery approximately two
weeks later.  Biopsies of the tumour will be taken at surgery and analysed for
TroVax stimulated immune activity. Further vaccinations will be given after
surgery. Patients' management will then continue as standard, usually
including adjuvant chemotherapy. Patients will be followed after the final
vaccination to assess immune responses and toxicity and then monitored over the
longer term for clinical benefit.

TroVax: commercial-scale manufacturing secured for larger trials

In September 2003, Oxford BioMedica signed a manufacturing agreement for the
supply of more than 10,000 doses of GMP grade TroVax to cover the requirements
for large randomised trials.  The manufacturing process is based on the same
technology commonly used for infectious disease vaccines. Since unit dose costs
can be kept to a minimum, the process is ideal for the commercial production of
TroVax.

Wyeth collaboration: Milestone achieved with anti-tumour antibody conjugate

Wyeth has completed key preclinical studies with Oxford BioMedica's
anti-tumour monoclonal antibody linked to calicheamicin, a potent cytotoxic
agent. These results trigger a further milestone payment to Oxford BioMedica
before the end of 2003.

The agreement with Wyeth was originally signed in January 2001. Earlier this
year, Wyeth exercised its option for an exclusive license to Oxford BioMedica's 
anti-tumour antibody for all human cancer indications. Wyeth has full
responsibility for the costs of development, marketing and manufacture of
products that arise from the programme. The potential value of the deal for
Oxford BioMedica is $24 million in upfront and milestone payments. Additionally,
Oxford BioMedica will receive royalties on product sales by Wyeth.

The successful preclinical work undertaken by Wyeth included optimising the
antibody and calicheamicin conjugate and conducting proof-of-efficacy studies in
relevant tumour models. Timelines for the completion of preclinical development
and initial clinical trials will be established in early 2004.

Intervet collaboration: Extension of deal on TroVax-VET

On 15 December 2003 an option to license agreement was signed with Intervet (a
division of Akzo Nobel) confirming the ongoing commitment of Intervet to the
development of novel animal cancer vaccines based on Oxford BioMedica's
technology. In January 2003, Oxford BioMedica announced the signing of a
research agreement with Intervet for the development of TroVax-VET. As reported
in January, the Company and Intervet entered negotiations for a full option to
license agreement for TroVax-VET and a number of other veterinary cancer
products arising from Oxford BioMedica's antigen discovery programme.

MetXia: Final results from second Phase I/II trial in breast cancer

Recruitment is now complete in the second Phase I/II trial with MetXia, mainly
in breast cancer patients. Recruitment was halted at eight patients because all
the requirements of the trial have been met, although patients will continue to
be monitored. This second Phase I/II trial is using an improved version of
MetXia that effectively increases the dose level. One of the goals of the trial
is to show that this higher potency form of MetXia is safe. The trial is also
designed to confirm the encouraging immune responses observed in an earlier
clinical trial of the original formulation of MetXia as well as to determine
whether the higher potency version of the product delivers the therapeutic gene
to tumours more efficiently in humans, as it does in preclinical models.

In line with initial results reported in July 2003 for the low dose group with
the improved formulation, the high dose patients have shown enhanced gene
transfer in all cases with no adverse effects of the treatment. Furthermore,
five out of seven patients assessed so far have shown an increased immune
response to known tumour molecules, confirming the immunogenic properties of
MetXia. Detailed data will be published next year in peer-reviewed journals and
at relevant conferences.

MetXia: MHRA approval for start of a Phase I/II trial in pancreatic cancer

On 11 December 2003, the Company received approval from the UK MHRA to proceed
with a Phase I/II study of MetXia in patients with pancreatic cancer. Two
leading clinical centres in Liverpool and Leicester have supported this
regulatory application and plan to commence recruitment before the end of the
year. The trial will be an open label study and will initially recruit six
patients to assess the safety of MetXia and to identify the optimal dose for the
second stage. In the second part of the trial, the cyclophosphamide prodrug will
be gradually escalated to identify a maximum tolerated dose. Up to 21 patients
will be recruited and endpoints include safety, clinical response and time to
disease progression.

Pancreatic cancer is amongst the most aggressive with median survival time of
only 6-12 months from diagnosis for inoperable cancers. Current treatment
options are primarily based on the chemotherapeutic agents 5-fluorouracil and,
more recently, gemcitabine. However, these have a minimal effect on median
survival underlining the need for novel therapeutic strategies.  Given the short
survival times and the lack of therapeutic options for this disease, positive
data from this trial could lead to accelerated approval for MetXia in this
indication.

Commenting on Oxford BioMedica's oncology programmes, Dr. Susan Kingsman, 
SVP Research & Development, said 'Overall we are pleased with the 
progress of TroVax and MetXia. Although patient recruitment has been rather
slow in some cases, the clinical data are encouraging. We are delighted to be
initiating clinical trial programmes in the USA and we expect patient
recruitment rates to be substantially faster in that environment. We are also
particularly pleased to see the Wyeth programme going so well'.

In regard to Oxford BioMedica's business development activities in
oncology, Nick Woolf, SVP Corporate Strategy, said 'We are very
encouraged by the strong support from our current partners. Furthermore, we have
received high levels of interest in our in-house pipeline, particularly TroVax,
and a key priority for Oxford BioMedica is to secure new collaborations for our
lead programmes in 2004.'



For further information, please contact:


Oxford BioMedica plc
Professor Alan Kingsman, Chief Executive               Tel: [phone]


City/Financial Enquiries:
Mike Wort, James Chandler: Beattie Financial           Tel: [phone]


Scientific/Trade Press Enquiries:
Sue Charles, Katja Stout: Northbank Communications     Tel: [phone]



Notes to editors

1. Oxford BioMedica

Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the
development of gene-based products for a range of unmet medical needs with an
emphasis on new cancer products, which combine novel mechanisms of action with
very low side effects, and innovative neurotherapy products, which address large
and, in several areas, untapped markets. The products are all protected by
multiple patents comprising a total intellectual property portfolio of some 69
patent families, which represents one of the broadest patent estates in the
field.

In addition to its technical research skill-base, Oxford BioMedica has in-house
clinical, regulatory and manufacturing know-how. The development pipeline
includes two novel anti-cancer products in clinical trials and a gene-based
treatment for Parkinson's disease, which is in late preclinical studies.

Oxford BioMedica has a wholly owned subsidiary in San Diego, USA. Oxford
BioMedica has corporate collaborations with Wyeth, Intervet, Amersham, Arius
Research, Kiadis and Viragen.

Further information is available at http://www.oxfordbiomedica.co.uk



2. TroVax(R) cancer immunotherapy

TroVax is Oxford BioMedica's leading cancer immunotherapy product. It is
designed specifically to stimulate an anti-cancer immune response and has
potential application in most solid tumour types. TroVax 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 poxvirus (MVA) gene transfer system, 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 protein.

Two Phase I/II trials with TroVax have been completed in the UK in late-stage
colorectal cancer patients. Following these successful Phase I/II trials, TroVax
has entered two Phase II trials in the UK in Stage IV colorectal cancer patients
receiving 5FU plus either oxaliplatin or irinotecan. The product is also
expected to enter further trials in colorectal, renal and breast cancer. The
renal and breast cancer trials are to be conducted in the United States under an
Investigational New Drug (IND) application. The renal cancer trial in the US is
expected to start enrolment in early 2004. Initial data from the first TroVax
Phase II trial in colorectal cancer have confirmed the product's safety
profile and have shown that an anti-tumour immune response can be mounted even
in the context of chemotherapy. Full results from the colorectal cancer Phase II
trials are anticipated in 2004.


3. MetXia(R) gene therapy for cancer

A common strategy for the treatment of cancer is to administer cytotoxic (or
cell killing) drugs in an attempt to destroy the tumour. Cyclophosphamide is one
of a group of drugs that is taken by the patient in the form of an inactive
prodrug. The prodrug travels through the body to the liver where enzymes convert
it to the active, cytotoxic form. This approach affects the whole body and leads
to the familiar adverse side effects of cancer chemotherapy because the
cytotoxic drug destroys normal cells on its way from the liver to the tumour. In
addition, because the activating enzymes are present only in the liver, high
doses of prodrug must be given to achieve therapeutic levels of the cytotoxic
drug at the tumour site. Often the therapeutic effect is compromised by the
toxicity.

Oxford BioMedica's MetXia addresses these problems by delivering a specific 
human cytochrome P450 gene (CYP2B6) directly to the tumour using a highly 
engineered retrovirus gene delivery system. Once incorporated into the
genetic material of the tumour cells, this gene produces the liver enzyme that
converts the cyclophosphamide pro-drug to its active form within the tumour. The
aim is to achieve high concentrations of activated cyclophosphamide locally in
the tumour while minimising circulating levels of the drug. It is anticipated
that this will lead to substantially increased sensitivity of the tumour to the
drug and to an ability to reduce the dose of cyclophosphamide, thereby reducing
adverse side effects.

A Phase I/II trial in late stage breast cancer and melanoma patients was
completed in 2002. The product was found to be safe, well tolerated and showed
some clinical benefit. In addition to local effects on tumour nodules that had
been treated with MetXia, there was evidence of induction of systemic
anti-tumour immune responses. A second Phase I/II study, using a higher potency
version of MetXia has now completed, showing that delivery of the therapeutic
gene to tumour cells is more than 10-fold better than in the previous trial and
also that patients are mounting an anti-tumour immune response, confirming the
observations made in the first trial. The safety profile of MetXia was also
maintained at the higher potency. The first clinical trial of MetXia in
pancreatic cancer is expected to start enrolment in early 2004 in the UK.


4. Anti-tumour antibody conjugate

Oxford BioMedica licensed its anti-tumour antibody for all human cancer
indications to Wyeth in a deal valued at a potential $24 million in upfront and
milestone payments, and royalties on sales. The deal was originally signed in
January 2001 and extended in February 2003. The most advanced product in
development from this collaboration is Oxford BioMedica's anti-tumour
antibody linked to calicheamicin, which is a potent cytotoxic agent. The product
has now successfully completed key preclinical proof-of-efficacy studies in
relevant tumour models.

Wyeth has expertise and proprietary technology in the conjugation of
calicheamicin to monoclonal antibodies. Calicheamicin is the active component of
Mylotarg(R), an antibody conjugate for the treatment of Acute Myeloid Leukaemia
that was launched in 2000 by Wyeth in the US.

Oxford BioMedica's antibody is directed against a novel proprietary
tumour-associated antigen that is expressed on a wide range of solid tumours.
Products developed under this agreement are therefore expected to be broadly
applicable in the treatment of many kinds of cancer.


5. TroVax(R)-VET

In collaboration with InterVet, Oxford BioMedica is developing a veterinary
version of TroVax. The product comprises the canine 5T4 gene delivered in a
poxvirus (MVA) vector.


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