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2005/OB/04
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OXFORD
BIOMEDICA AND VIRAGEN REPORT PROGRESS IN AVIAN TRANSGENICS
BIOMANUFACTURING
Oxford
BioMedica (LSE: OXB), the leading gene therapy company, today
announced progress in the programme of its collaborative partner
Viragen, Inc (AMEX: VRA). Viragen, in collaboration with the
Roslin Institute, is developing avian transgenic biomanufacturing
for the purpose of using chickens as bioreactors for the efficient
and economical production of human pharmaceutical protein-based
drugs in their eggs.
Viragen
reported that an antibody designed to treat malignant melanoma
(anti-GD3 antibody) has been successfully detected in the
blood of a founder transgenic rooster after the antibody was
introduced using Oxford BioMedica’s proprietary LentiVector®
gene delivery system. This achievement is the first in a series
of steps designed to confirm that a humanised antibody can
be produced in subsequent generations of chickens and demonstrate
a fully intact structure capable of its intended therapeutic
function.
Project Leader,
Roslin’s Dr. Helen Sang, explained: "We have previously
demonstrated that a reporter gene can be synthesised in the
oviduct of laying hens, the source of egg white proteins.
The significance of this new milestone is that we are now
using a humanised anti-cancer antibody which has been incorporated
into the bird’s DNA."
Dr. Sang also discussed
the project’s goal to demonstrate tissue-specific expression
in the oviduct: "We have now shown that a protein can
be synthesised in the oviduct of transgenic hens, the source
of egg white proteins. These results indicate that we are
well advanced towards our stated target of tissue-specific
expression of a therapeutic protein – a key milestone
in our development plan."
"These collective
results are extremely encouraging and give us good reason
to believe that additional important milestones could be reported
in the coming months," stated Viragen’s President
and CEO, Mr. Charles A. Rice. "We are developing similar
work utilising a second therapeutic protein which has global
sales of approximately $2 billion. As we continue to realise
these significant milestone events, the time is approaching
for scheduling meetings with the appropriate international
regulatory agencies, including the FDA, to determine the steps
that will be required to bring this exciting technology to
the market."
In other
avian transgenic-related news, it was announced that a scientific
article has been published in Drug Discovery Today (Volume
10, Number 3, February 2005). The article, titled "Transgenic
chickens as bioreactors for protein-based drugs", reports
on significant advances to develop avian transgenics.
Co-authored
by Dr. Helen Sang*, the article concludes that: "Recent
improvements of transgenic technology for chickens and preliminary
results on protein expression in birds are encouraging."
-
ends -
*Authors:
Simon G. Lillico, Michael J. McGrew, Adrian Sherman and Helen
M. Sang; Roslin Institute
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Notes
| 1. |
Oxford
BioMedica |
|
Oxford
BioMedica (LSE: OXB) is a biopharmaceutical
company specialising in the development
of novel gene-based therapeutics with a
focus on the areas of oncology and neurotherapy.
The Company was established in 1995 as a
spin out from Oxford University, and is
listed on the London Stock Exchange.
Oxford
BioMedica has core expertise in gene delivery,
as well as in-house clinical, regulatory
and manufacturing know-how. In oncology,
the pipeline includes an immunotherapy and
a gene therapy in multiple Phase II trials,
and a preclinical targeted antibody therapy
in collaboration with Wyeth. In neurotherapy,
the Company’s lead product is a gene
therapy for Parkinson’s disease, which
is expected to enter clinical development
in 2005, and four further preclinical candidates.
The Company is underpinned by over 80 patent
families, which represent one of the broadest
patent estates in the field.
The
Company has a staff of approx. 65 split
between its main facilities in Oxford and
its wholly owned subsidiary, BioMedica Inc,
in San Diego, California. Oxford BioMedica
has corporate collaborations with Wyeth,
Intervet, Amersham, Viragen, MolMed and
Kiadis; and has licensed technology to a
number of companies including Merck &
Co and Biogen Idec. |
| 2. |
LentiVector®
technology |
| |
Oxford
BioMedica’s LentiVector gene delivery
technology, based on lentiviral vectors,
is arguably the most potent system currently
available for treating a range of diseases,
particularly those of the central nervous
system. Oxford BioMedica has shown that
its lentiviral vectors are able to deliver
genes with high efficiency to a variety
of both dividing and non-dividing cells,
including neurons in the brain.
Oxford
BioMedica has a comprehensive portfolio
of US and European patents covering the
LentiVector technology, which supports the
LentiVector-based pipeline and its technology
licensing activities. The Company has established
a neurotherapy pipeline of product candidates
based on the technology, which includes
ProSavin® for Parkinson’s
disease, RetinoStat® for
retinopathy, MoNudin® for
motor neuron disease and Innurex®
for nerve repair. In addition to its application
in therapeutic products, the LentiVector
technology is an effective tool for genomics-based
target validation, screening, production
systems, and the creation of transgenic
animals. |
| 3. |
Viragen,
Inc |
| |
Viragen
(AMEX: VRA) is a biotechnology company specialising
in the research, development and commercialisation
of natural and recombinant protein-based drugs
designed to treat a broad range of viral and
malignant diseases. These protein-based drugs
include natural human alpha interferon, monoclonal
antibodies and a peptide drug. Viragen’s
strategy also includes the development of
Avian Transgenic Technology as a biomanufacturing
platform for the large-scale, cost-effective
production of therapeutic proteins.
Viragen is publicly traded
on the American Stock Exchange (VRA). Viragen’s
majority owned subsidiary, Viragen International,
Inc., is publicly traded on the Over-The-Counter
Bulletin Board (VGNI). Viragen’s key
partners and licensors include: Roslin Institute,
Memorial Sloan-Kettering Cancer Center,
Cancer Research UK, University of Nottingham
(U.K.), University of Miami, America’s
Blood Centers and the German Red Cross.
For more information, please
visit: http://www.viragen.com/
For an Avian Transgenic
Technology Profile, please visit: http://www.viragen.com/aviantechprofile.pdf
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| 4. |
Oxford
BioMedica and Viragen collaboration |
| |
On
5 July 2004, Oxford BioMedica and Viragen
entered a license agreement for Oxford BioMedica’s
LentiVector gene delivery technology. The
agreement provides Viragen with worldwide
exclusive rights to utilise the technology
in its collaboration with Roslin Institute
(Scotland) to develop Avian Transgenic Technology
as a novel platform for the efficient and
economical manufacturing of therapeutic proteins
in chicken eggs. Under the agreement, Viragen
is funding the development and Oxford BioMedica
receives an upfront license fee and annual
maintenance payments. In addition, Oxford
BioMedica will receive milestone payments
on the achievement of technical goals by Viragen
and royalties on commercialisation of the
Avian Transgenic Technology. |
| |
| For
further information please contact:
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Oxford BioMedica plc
Professor Alan
Kingsman, Chief Executive
Peter Nolan, SVP Commercial Development
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Tel: +44 (0)1865 783 000 |
Viragen,
Inc
Douglas Calder, Director of Communications
|
Tel:
+1 954 233 8746 |
| City/Financial
Enquiries
Lisa
Baderoon/Mark
Court/Mary-Jane
Johnson
Buchanan Communications |
Tel: +44 (0)20 7466 5000
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Scientific/Trade
Press Enquiries
Sue
Charles, Katja
Stout, Ashley
Lilly
College Hill - Life Sciences |
Tel:
+44 (0)20 7886 8150 |
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