ROUSSAY, FRANCE--(Marketwire - Aug 21, 2012) - Successful growth of BioDiem's Virus in
VIVALIS EB66(®) Cell Line
Highlights:
* BioDiem confirms successful and abundant growth of its virus in
VIVALIS'
proprietary EB66(®) cell line in Stage 1 of its collaboration with
VIVALIS.
* The next stage of the project will use known techniques to demonstrate
the
creation of new, 'disarmed' viruses (vectors) carrying foreign antigens
that
can be customized to fight specific diseases.
* Both BioDiem's LAIV virus and VIVALIS' EB66® have produced
vaccines which
have been through Phase II clinical trials, facilitating
commercialisation.
Melbourne (Australia), Nantes (France), 21 August 2012: Australian
infectious
disease therapy and vaccine development company BioDiem Ltd (ASX: BDM)
announced
today successful results from two programs of work carried out by French
partner
VIVALIS (NYSE Euronext: VLS), confirming the ability of BioDiem's Live
Attenuated Influenza Virus (LAIV) to grow in VIVALIS' proprietary
EB66(® )cell
line.
The next stage of the collaboration between BioDiem and VIVALIS will use
known
techniques to modify the LAIV virus to demonstrate and optimize the
methodology
for making a customizable "vector" which could be used by vaccine
developers for
the development of new vaccines targeting other specific diseases.
Priority
disease targets include nasopharyngeal carcinoma and respiratory syncytial
virus
infection.
The results are significant for both companies, as both the BioDiem LAIV
virus
and the VIVALIS EB66(®) cell line have been used to produce vaccines
that have
been tested in successful Phase II clinical trials. The resulting human
safety
data will facilitate a shorter and lower cost path to commercialisation on
completion of the next stage of development with VIVALIS.
BioDiem has world-leading in-house expertise in the LAIV virus, and is
committed
to expanding the value of the technology by developing specific disease
treatments. The proposed vector would take advantage of LAIV's safety
profile
and low toxicity (as the virus backbone is already weakened), intranasal
spray
delivery, and the ability to be customised to target particular diseases.
VIVALIS undertook this research based on the high potential value of
BioDiem's
technology in non-influenza vaccine applications, both therapeutic and
preventative. This work has confirmed the successful and abundant growth of
LAIV
in VIVALIS' EB66(® )cell line. The next step will be the development
of a stable
LAIV vector technology which uses EB66(®) as a base platform for
growth.
"We're delighted to have emphatically confirmed the feasibility of growth
of our
LAIV in conjunction with VIVALIS EB66(® )technology. BioDiem is
excited about
the use of our in-house viral technology to establish a platform for new
vaccine
creation via the vector project. We will now move to finalise planning the
most
effective development program for the vector," said Julie Phillips, BioDiem
CEO.
"We are very pleased to report the successes to date of this research
project.
We are focused on moving EB66(® )into exciting new indications, such
as the
therapeutic and preventative vaccines potentially offered by BioDiem's LAIV
technology", said Franck Grimaud, CEO, and Majid Mehtali, CSO, co-managers
of
VIVALIS.
The next steps for BioDiem's vector program will revolve around further
development of the vector platform, establishment of a best practice
production
process, and licensing and manufacturing agreement establishment.
ENDS
About BioDiem Ltd
BioDiem is an ASX-listed company based in Melbourne with an international
focus
on discovering, developing and commercialising world-class research and
technology targeting cancers and infectious diseases. BioDiem's core
technologies include the Live Attenuated Influenza Virus (LAIV), the SAVINE
platform and the BDM-I antimicrobial compound. BioDiem has also in-licensed
vaccine technologies from Australian National University and the University
of
Canberra with initial target indications of dengue fever and hepatitis
respectively.
The LAIV influenza vaccine is an intranasal vaccine to prevent infection
from
seasonal and pandemic influenza. The LAIV influenza vaccine can be produced
using both egg-based and cell-based manufacturing methods. The cell-based
LAIV
vaccine has completed a Phase II clinical trial in Europe. The egg-based
LAIV
vaccine technology is licensed to the World Health Organization as part of
the
Global Pandemic Influenza Action Plan to Increase Vaccine Supply.
The LAIV influenza vaccine is marketed as Nasovac™ in India by the Serum
Institute of India, and has been licensed to China-based Changchun BCHT
Biotechnology Co. The LAIV vaccine was in-licensed from the Institute of
Experimental Medicine in St Petersburg, Russia where it has been used for
over a
decade in many millions of people - children, adults and the elderly. The
LAIV
is administered by nasal spray and induces a rapid immune response in the
mucosal lining of the nose and pharynx.
The LAIV is also being developed as a viral vector for making novel
non-influenza vaccines for different diseases including cancers. Viruses
have the
ability to generate proteins prolifically and can be programmed to produce
disease-specific proteins. As part of a vaccine, disease-specific proteins
can
help generate a beneficial immune response. BioDiem is advancing its two
new
vaccine and vaccine vector programs in partnership with France-based
developer
VIVALIS and the Royal Melbourne Institute of Technology (RMIT).
SAVINE (patented Scrambled Antigen Vaccine) is a platform technology for
the
design of antigens for incorporation into vaccines targeting an immune
response
to a range of different diseases. SAVINE antigens are encoded as synthetic
genes
which, together with a delivery technology such as BioDiem's LAIV-based
vaccine
vector technology, can be used to develop novel vaccines.
BDM-I is a synthetic compound targeted at the treatment of serious human
infections. BDM-I is in the preclinical stage with outlicensing as the
intended
outcome. BDM-I is active against a range of pathogenic micro-organisms
including
gram-positive and gram-negative bacteria, fungi and protozoa. Key patents
have
been granted in both Europe and the US around BDM-I's antimicrobial
activity.
BioDiem is also developing BDM-E, a tetra peptide synthetic compound, as a
treatment for ophthalmic disorders. The US Food & Drug Administration
(USFDA)
has granted Orphan Drug designation to BDM-E for the treatment of retinitis
pigmentosa, a serious degenerative disease of the retina.
BioDiem's research is ongoing in partnership with internationally
recognised
research groups.
For additional information, please visit www.biodiem.com
About VIVALIS (www.vivalis.com)
VIVALIS (NYSE Euronext: VLS) is a biopharmaceutical company that provides
innovative cell-based solutions to the pharmaceutical industry for the
manufacture of vaccines and proteins, and develops drugs for the prevention
and
treatment of unmet medical needs. VIVALIS' expertise and intellectual
property
are leveraged in two main areas:
EB66(®) Cell Line
VIVALIS offers research and commercial licenses for its EB66® cell
line, derived
from duck embryonic stem cells, to pharmaceutical and biotechnology
companies
for the production of therapeutic and prophylactic viral vaccines,
virosomes,
VLP's, and recombinant proteins (with a focus on monoclonal antibodies
having
enhanced cytotoxic activity). Through these programs VIVALIS receives
upfront,
clinical, and milestone payments along with royalties on licensees net
sales.
VIVA|Screen™ Human Antibody Discovery Platform
Customized solutions for the discovery, development, and production of
fully
human monoclonal antibodies are now offered by VIVALIS. Through these
programs
VIVALIS receives upfront, clinical stage milestone payments along with
royalties
on licensees net sales.
Based in Nantes & Lyon (France) and in Toyama (Japan) VIVALIS was founded
in
1999 by the Grimaud Group (ca. 1,700 employees), a worldwide leader in
animal
genetic selection. VIVALIS has established more than 30 partnerships and
licenses with world leaders in this sector, including Sanofi Pasteur,
GlaxoSmithKline, Transgene, Pfizer Animal Health, Kaketsuken, Kitasato
Daiichi
Sankyo Vaccine, Merial, Merck Animal Health, and SAFC Biosciences. VIVALIS
is a
member of the French ATLANTIC BIOTHERAPIES and LYON BIOPOLE bioclusters and
a
member of the Japanese HOKURIKU INNOVATION CLUSTER FOR HEALTH SCIENCE in
Toyama.
VIVALIS
Listed on Euronext Paris - Compartment C of NYSE Euronext
Reuters: VLS.PA - Bloomberg: VLS FP
Included in NYSE Euronext's SBF 250, CAC Small 90 and Next Biotech indexes
This document contains forward-looking statements and comments on the
company's
objectives and strategies. No guarantee can be given as to any of the
events
anticipated by the forward-looking statements, which are subject to
inherent
risks, including the risk factors described in the company's document de
référence, changes in economic conditions, the financial markets
or the markets
in which the company operates.
Successful growth of BioDiem?s Virus in VIVALIS EB66® Cell Line:
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