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Inovio Approach for Universal Flu Vaccine
Product & Indication
VGX?-3400 is a proprietary, prophylactic DNA vaccine candidate being developed by Inovio. This vaccine is designed to prevent infection with the avian influenza (H5N1), which is highly pathogenic in humans. Over 200 human cases have been confirmed in Asian countries with an alarmingly high mortality rate of >50%. The vaccine is being delivered using Inovio's CELLECTRA? DNA Delivery System. The plasmid vaccine is delivered into muscle tissue with the assistance of electroporation with the goal of achieving expression of the H5N1 influenza antigens.
Market Potential
Influenza is one of the most communicable diseases and it typically is most severe in young children and the elderly. Typically, an influenza season strikes both hemispheres each year, resulting in three to five million cases of severe illness and up to 500,000 deaths annually. In addition, pandemics occur every ten to twenty years, with the potential to kill tens of millions of people. The "Spanish Flu" of 1918-1919 resulted in an estimated 50-100 million deaths.
New influenza viruses are constantly produced by mutation or by reassortment, and can develop resistance to standard antiviral drugs. The H5N1 strain has been spreading from Asia despite thoughts that it was under control after outbreaks there in 2004. In 2005, there were reports of H5N1 in wild birds in Europe. In 2006, there were reports of avian influenza A H5N1 strain in wild birds and poultry in Africa and the Near East.
Stage of Development
Phase: IND filed.
Commercialization
Vaccine: Licensed from The University of Pennsylvania.
Delivery technology: owned by Inovio.
License agreement: Financial details undisclosed. VGX?-3400 has been manufactured under cGMP by VGXI, Inc. and has been formulated for Phase I clinical trials.
Inovio Approach for Universal Flu Vaccine
<hr> VGX?-3400 (H5N1) Pre-IND Updates
hat-tip to Blue . . .
Product & Indication
VGX?-3400 is a proprietary, prophylactic DNA vaccine candidate being developed by Inovio. This vaccine is designed to prevent infection with the avian influenza (H5N1), which is highly pathogenic in humans. Over 200 human cases have been confirmed in Asian countries with an alarmingly high mortality rate of >50%. The vaccine is being delivered using Inovio's CELLECTRA? DNA Delivery System. The plasmid vaccine is delivered into muscle tissue with the assistance of electroporation with the goal of achieving expression of the H5N1 influenza antigens.
Market Potential
Influenza is one of the most communicable diseases and it typically is most severe in young children and the elderly. Typically, an influenza season strikes both hemispheres each year, resulting in three to five million cases of severe illness and up to 500,000 deaths annually. In addition, pandemics occur every ten to twenty years, with the potential to kill tens of millions of people. The "Spanish Flu" of 1918-1919 resulted in an estimated 50-100 million deaths.
New influenza viruses are constantly produced by mutation or by reassortment, and can develop resistance to standard antiviral drugs. The H5N1 strain has been spreading from Asia despite thoughts that it was under control after outbreaks there in 2004. In 2005, there were reports of H5N1 in wild birds in Europe. In 2006, there were reports of avian influenza A H5N1 strain in wild birds and poultry in Africa and the Near East.
Stage of Development
Phase: IND filed.
Commercialization
Vaccine: Licensed from The University of Pennsylvania.
Delivery technology: owned by Inovio.
License agreement: Financial details undisclosed. VGX?-3400 has been manufactured under cGMP by VGXI, Inc. and has been formulated for Phase I clinical trials.
Inovio Approach for Universal Flu Vaccine
- DNA vaccine targeting variable influenza HA: [H1, H2, H3, and H5 (Avian)] along with Conserved Regions of NA and M2e-NP.
- All constructs are made using SynCon? technology
- Proof of concept studies completed showing immunogenicity and protection against H1 and H5 Viruses in Animal Models.
- Potential for long-term immunity
- Pre-set vaccine regimens for each year
- SynCon? DNA Vaccines for Avian Flu (H5N1) - HA, NA, M1, M2-eNP
- Study Design:
Mice (10/group) immunized with 10 ?g DNA at wk 0, 2, 4 and with 25 ?g DNA at wk 8
Animals challenged with aerosolized lethal dose of Vietnam strain of Avian H5 virus
- Efficacy Data in Animal Models
- Strong Neutralizing Antibody Responses in 5 Separate Preclinical Species
- Strong CD8+ T cell Responses
- IND-enabling Toxicity Testing in Animals Completed
- cGMP Manufacturing of Phase I Clinical Product
- Conducted at VGXI manufacturing facility in TX
hat-tip to Blue . . .