Friday, July 25, 2008

INOVIO - INO

Since I just bought some INO I figured I should spell out why I bought and what I expect.

It all centers around this VGX merger that is now proposed and underway. Inovio has an electroporation device which injects a vaccine into humans. VGX has the DNA vaccine which in mouse studies worked to provide 100% immunity against highly pathogenic H5N1 - avian flu:

1)

Inovio/VGX merger to expedite DNA vaccine development

By Gareth Macdonald

09-Jul-2008 - Electroporation specialist Inovio Biomedical Corp and vaccine developer VGX Pharmaceuticals believe that their recently announced merger will create a firm capable of rapidly moving DNA vaccine candidates from the laboratory to the clinic.

The definitive agreement, which has been approved by the boards of both firms but is still subject to clearance by stockholders, will integrate Inovio's electroporation technology with VGX's pipeline of developmental DNA vaccines and Cellectra delivery platform.

In January this year, BCC research forecast that the global market for therapeutic vaccines, which is valued at around $20bn (€12.7bn), will be worth $34bn by 2013, representing a compound annual growth rate of nearly 11 per cent.

While traditional antigen-based products will continue to dominate the sector, the benefits offered by DNA vaccines in terms of minimized side effect profile make any successful technology an attractive proposition.

"We are highly confident that the combined company will advance the potential of developing and delivering new DNA vaccines that could play a significant role in treating or even preventing diseases. Leadership of both companies could not forego this medical and market opportunity," commented Avtar Dhillon, Inovio Biomedical's CEO.

Joseph Kim, co-founder, president and CEO of VGX Pharmaceuticals, said that: "Significant, growing evidence indicates that electroporation has a pivotal role to play in enabling the potency of this promising new generation of vaccines and VGX has already made a strong commitment to this DNA delivery technology."

FDA accepts VGX's DNA cervical cancer vacc IND

Earlier this month, the US Food and Drug Administration (FDA) approved VGX's Investigational New Drug (IND) application for the DNA vaccine for cervical cancer, VGX-3100. Following the decision, the firm announced plans to initiate a Phase I clinical trial in the third quarter this year.

At present, the cervical cancer vaccine market is shared between Merck and Sanofi Pasteur's Gardasil and GlaxoSmithKline's (GSK) Cervarix. Both products are traditional antigen-based vaccines that incorporate a limited range of antigens present in the most commonly circulating human papilloma virus (HPV) strains.

In contrast, VGX-3100 is a DNA vaccine that has been designed to offer protection against a wide range of HPV viruses. The product was developed using VGX's SynCon DNA antigen platform, which aligns a selection of primary DNA sequences for each antigen and selects the base that is most common or relevant at each position using a series of sophisticated statistical algorithms.

The selected composite antigens are then included in the vaccine. VGX claims that the approach allows it to identify the DNA sequences that are most likely to elicit cross-reactive immunity to the widest range of HPV viruses, thereby providing enhanced immune protection.

Source

2)
Inovio Biomedical's First Proprietary DNA Vaccine Achieves 100% Protection Against Avian Flu in Pre-Clinical Testing

Wednesday July 16, 6:00 am ET

Results Suggest Experimental DNA Vaccine May Protect Against Multiple Seasonal and Pandemic Influenza Strains

SAN DIEGO--(BUSINESS WIRE)--Inovio Biomedical Corporation (AMEX:INO - News), a leader in enabling the development of DNA vaccines using a proprietary electroporation-based DNA delivery platform, announced today pre-clinical results from two proprietary plasmid DNA-based universal influenza vaccine candidates using the companys proprietary electroporation delivery technology and, specifically, a new intradermal device. In this study, 100% of the immunized mice given a lethal challenge of highly pathogenic H5N1 influenza virus (A/Vietnam/1203/04) survived and showed only minor weight loss.

The DNA vaccine design was based on a different influenza strain (H1N1) than the influenza strain used in the challenge, providing evidence that a universal vaccine based on conserved genes common to multiple strains of seasonal influenza and even potential pandemic influenza may have the possibility to provide widespread protection against such viruses. In collaboration with Vandalia Research Inc., Inovio also tested the use of fully synthetic linear expressing cassettes (LEC) to express the same antigens and achieved similar results. These results were presented by Dr. Michael Fons, VP Corporate Development, on July 15th at the Controlled Release Society 35th Annual Meeting and Exposition.

Were enthusiastic about these very early results because todays strain-specific (homologous) influenza vaccines cannot provide universal protection against seasonal influenzas and potential pandemic influenza strains. Only a broad-spectrum (heterologous) influenza DNA vaccine, such as the one were testing, would have the potential to provide protection against multiple known and unknown influenza strains. Our hope is that such a universal vaccine may one day replace the standard seasonal vaccine and provide protection against the generally inconvenient symptoms as well as the more severe effects, including death, that can result from seasonal and pandemic influenzas, said Inovio CEO Dr. Avtar Dhillon.

Current strain-specific influenza vaccines are designed to stimulate an immune response specific to a single influenza strain. Given that seasonal flu can rapidly mutate, such homologous vaccines may provide modest protection against variant influenza strains but cannot fully prevent the contagion from widely spreading and causing not only the familiar symptoms of the common cold but, in some cases, death. The major risk of pandemic influenza is that new virulent strains of influenza, such as the avian flu, which have never spread widely through a human population, would potentially result in harsher symptoms and widespread death because of the bodys delay in naturally building immunity to the virus and the inability to develop and distribute in a timely manner a vaccine specific to that influenza strain.

The concept of a universal broad-spectrum vaccine is based on emerging scientific knowledge that conserved regions of the influenza genome are not under dramatic selective pressure to mutate. These genes and the antigens they express are common across most strains of influenza. This creates the possibility to develop heterologous influenza vaccines without knowing the genetic make-up of a future influenza strain that may have the potential to, for example, migrate from animals to man and pose pandemic risk.

This pre-clinical work involved two other technology advancements Inovio has been developing or co-developing:

1) Fully synthetic linear expressing cassettes (LEC), or linear constructs, represent a new type of carrier mechanism for the genes that comprise a DNA vaccine. Numerous clinical studies have provided evidence that DNA plasmids are inexpensive, safe, and effective for delivering DNA vaccines. LECs are a next generation of synthetic DNA constructs that are easier, faster and cheaper to make, while providing equivalent utility.

2) Inovio has developed a multi-product line of electroporation devices that can provide different electroporation parameters in different types of tissue. This pre-clinical work used a new intradermal device intended to deliver a DNA vaccine into skin rather than muscle, the tissue type that is the focus of Inovios existing clinical studies. Delivering a vaccine into skin creates the potential for greater tolerability and would therefore make such a device more acceptable for prophylactic (preventive) vaccination.

About Inovio Biomedical Corporation

Inovio Biomedical (AMEX:INO - News) is focused on developing multiple DNA-based immunotherapies. Inovio is a leader in developing human applications of electroporation using brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical. Interim human data has shown that Inovios DNA delivery technology, which is protected by an extensive patent portfolio covering in vivo electroporation, can significantly increase gene expression and immune responses from DNA vaccines. Immunotherapy partners include Merck, Wyeth, Vical, University of Southampton, Moffitt Cancer Center, the U.S. Army, National Cancer Institute, and International Aids Vaccine Initiative. Inovio and VGX Pharmaceuticals have announced a proposed merger. More information is available at www.inovio.com.

Source

3)
Inovio says Tripep reported addnl. interim results from hepatitis C virus phase I/II clinical study - Quick Facts

06/30/2008 6:36AM - RTT News

(RTTNews) - Inovio Biomedical Corp. (INO) said Monday that its partner, Tripep AB, reported additional interim results from its ongoing phase I/II clinical study of its ChronVac-C therapeutic DNA vaccine, which is delivered using Inovio's electroporation-based DNA delivery system.

The preliminary results are from the first two patients in the intermediate dose group to complete treatment against hepatitis C virus infection. Samples taken before, during and after treatment showed that the viral levels in blood decreased up to 87% and 98%, respectively, during treatment. Simultaneous activation of the patients' T-cell responses to the hepatitis C virus was recorded in conjunction with the viral load reductions. Inovio's electroporation delivery technology is intended to enhance the potency of DNA vaccines against cancers and infectious diseases.

ChronVac-C is a therapeutic vaccine given to individuals already infected with the hepatitis C virus with the aim of clearing the infection from the liver by boosting the body's immune response against the virus.

For comments and feedback: contact editorial@rttnews.com

Source
Why the merger?:

Commercialization
Vaccine: owned by VGX.
Delivery technology: owned by Inovio.
Source

That kinda says it all - all under one roof, now.

5)
What do I expect?

Great things - a single DNA vaccine for multiple viruses of the same family, concocted to avoid mutations.

6)
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