GenOdyssee (GO), a biotechnology
company dedicated to the discovery and development of improved 'next
generation' human protein therapeutics, announced 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 genodyssee
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.
GenOdyssee SA
genodyssee