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24.10.2008 – 15:14

GenOdyssee SA

GenOdyssee Receives Broad Product Applications Protection in EU for Founding Natural Evolution Technology

Paris (ots/PRNewswire)

- GenOdyssee Has Received Notice of Allowance of European Patent
Application Covering Its Core Natural Evolution Technology Invented
in 2002, and Received Broad Product Applications Protection Rights to
All Cytokine Families
GenOdyssee (GO), a biotechnology company dedicated to the
discovery and development of improved 'next generation' human protein
therapeutics, announced today that it has received notice of
allowance from the European Patent Office of its Patent Application
no.3 785 733.1 (PCT/EP03/13965) covering its core founding drug
discovery technology process entitled "Method For Providing Natural
Therapeutic Agents With High Therapeutic Index" for applications to
all therapeutic cytokine families.
The company pioneered the vision that natural evolution has
created in the general population superior genetic variants of key
human protein therapeutic drugs as compared to the first wave of
reference protein therapeutic variants isolated and developed during
the first biotech boom in the 80s, which currently constitute
standard of care.
"We have always believed that our technology has wide potential
in the industry for discovery of second generation products. Our IFN
and EPO products have been granted IP in all major countries in which
we filed a product patent application, including the EU and the USA.
Our IP portfolio now extends to 53 patents and patent applications in
more than 19 countries. Importantly, the European patent office has
now granted our technology broad product protection rights across all
cytokine families. The granting of such broad IP product rights is
relatively unusual and has been achieved in this case because
GenOdyssee successfully demonstrated successful application of its
technology across multiple products in various cytokine families,"
said Dr. David Brown, senior executive advisor for science & bus dev
to GenOdyssee.
"This confirms the uniqueness of our proprietary technology as
well as the global leadership of our company's platform in the
protein therapeutics optimization arena. There is potential to apply
our technology to additional important classes of therapeutic
cytokines such as Interleukins and CSFs," added Dr. Escary, chief
executive officer.
The company's first lead product is a novel, natural human IFN
alpha variant protein called GEA007.1, a protein which is found in
all major human populations It is a naturally occurring variant of
human IFN alpha 17, which incorporates an innovative amino acid
substitution G45R that provides a novel positive charge together with
a change in 3-D structure of the protein receptor binding site. The
biochemical and structural modifications induced in the protein
binding site provide for superior anti-HCV efficacy using the
industry gold standard replicon assay without significantly increased
toxicity as demonstrated in Rhesus Monkeys compared to standards of
care IFN alpha 2 molecules. GEA007.1 product patent applications have
been granted in the EU and in the USA and are pending in an
additional 17 countries including Japan and emerging countries like
China where HCV is also a major health problem.
Examination procedures by the international patent offices have
not revealed any relevant prior art to such product or to the natural
evolution technology invented by the company.
About GenOdyssee S.A.
GenOdyssee applies its proprietary population-genetics-based drug
discovery approach using a proprietary DNA databank representative of
more than 90% of the different ethnicities that constitute the
current human population, which is screened for natural genetic
variants of therapeutic proteins with superior pharmacological
properties. The company pioneered the vision that natural evolution
has led to the generation in the current population of unpredictable
mutations that confer superior or novel therapeutic status to known
important human therapeutic proteins. GenOdyssee's technology is
protected by the international patent application PCT/EP03/13965 and
is the sole property of the company.
This technology has allowed GenOdyssee to identify in the
population a variety of innovative variations on existing key protein
drugs such as IFN alphas and EPO and to convert such variations into
novel drug candidates. The company's lead virology and immunotherapy
drug candidates are GEA007.1 and GEA009.2, respectively targeted at
treatments of HCV infection and cancer.
For more information about the company, please visit the
company's website at http://www.genodyssee.com
About GEA007.1
GEA007.1 is a novel and first in man natural human IFN alpha
protein variant identified using the company's proprietary natural
evolution technology. It is found in all major human populations
(Pacific, Iberian, Italian, Mexican, African, Caucasian, Chinese,
Indo-Pakistan, Middle-Eastern, Japanese). GEA007.1 is a naturally
occurring variant of human IFN alpha 17, which incorporates an
innovative amino acid substitution G45R that provides a novel
positive charge together with a change in 3-D structure of the
protein receptor binding site. The biochemical and structural
modifications induced in the protein binding site provide for
superior anti-HCV efficacy without increased toxicity of GEA007.1 as
compared to IFN alpha 2 which is the core agent of current standard
of care. Long lasting second generation pegylated IFN alpha 2's have
given major improvements in HCV therapy in combination with
ribavirin.
GEA007.1 is particularly positioned for use in HCV genotype 1
which has become the predominant genotype worldwide and which is the
most difficult to treat, as well as in patients infected with HCV
genotype 3 because of the following properties:
  • Stronger anti-HCV activity in fresh human hepatocytes infected with HCV type 3 (genotype 3a) virus, in which GEA007.1 reduced HCV RNA to levels 3-4 fold lower than IFN alpha 2 drugs.
  • Stronger anti-HCV activity in vitro in the HCV genotype 1b subgenomic replicon assay (BM4-5 cells) as compared to IFN alpha 2. GEA007.1 exhibits a 7 fold superior inhibitory activity on HCV genotype 1b RNA synthesis compared to IFN alpha 2.
  • Viral clearance of HCV genotype 1b replicon subgenome was obtained in BM4-5 cells after long-term administration (20 days) of GEA007.1, as evidenced by elimination of HCV genotype 1b RNA (both strands) replicon genome. In contrast, HCV genotype 1b RNA (both strands) was still apparent in cells treated with IFN alpha 2 in same conditions.
  • No rebound of HCV genotype 1 replication after cessation of GEA007.1 treatment. HCV subgenomic RNA remained undetectable after 5 passages post-treatment in GEA007.1 treated cells, whereas a low amount of positive strand HCV subgenomic RNA was maintained in IFN alpha 2 treated cells.
  • Similar safety pharmacology in rhesus monkeys (Macaca mulatta) to IFN alpha 2.
  • Importantly, GEA007.1 is a natural human protein, which means it is already functional and tolerated in man.
CONTACT: Dr. Jean-Louis Escary, CEO
    Tel: +33(0)616-416-857
    Email: escary@genodyssee.com

Contact:

CONTACT: Dr. Jean-Louis Escary, CEO, Tel: +33(0)616-416-857, Email:
escary@genodyssee.com