Showing posts with label DNA vaccine. Show all posts
Showing posts with label DNA vaccine. Show all posts

Tuesday, June 2, 2009

Inovio Biomedical Influenza DNA Vaccines Demonstrate Potential to Protect Against Newly Emerging Flu Strains with Pandemic Potential

Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine discovery, development and delivery, announced today preclinical data from two studies of influenza DNA vaccines designed using its SynCon™ technology. The data indicated that the consensus H1N1 and H5N1 influenza vaccines achieved significant increases in immune response and provided protection against influenza virus strains not genetically matched to the vaccine, which is a requirement for conventional vaccines to be effective and a limitation to their effectiveness, i.e. they can’t protect against newly emerging strains. Dr. Niranjan Sardesai, Senior VP, Research & Development of VGX Pharmaceuticals, which merged with Inovio Biomedical on June 1, 2009, presented this data at the 12th Annual Meeting of the American Society of Gene Therapy held in San Diego, CA, May 27 - 30, 2009, in a presentation entitled, "Improved Challenge Outcome Following Intradermic Vaccination by Electroporation of a Consensus H5N1 Influenza DNA Vaccine in Non-Human Primates.”

In the first study, the scientists immunized non-human primates with a consensus H5N1 avian influenza vaccine (VGX-3400). Delivered using the Company’s in vivo electroporation device, the vaccine achieved high levels of protective antibody titers against unmatched clade 1 and multiple unmatched clade 2 H5N1 viruses. The animals were then challenged with the unmatched A/Vietnam/1203/04 strain. There was a significant reduction in average viral load (amount of virus in the blood stream) and decreased symptoms of disease in all the vaccinated animals compared to unvaccinated controls. Animals vaccinated by the intradermal route had a greater than 10,000-fold reduction in average viral load compared to untreated controls, an unprecedented result in comparative studies with similar animal models. These results were recently published in the May issue of the Journal of Virology. [Electroporation of Synthetic DNA Antigens Offers Protection in Nonhuman Primates Challenged with Highly Pathogenic Avian Influenza Virus]

In the second study, the scientists immunized mice with the SynCon™ H1HA consensus DNA vaccine. They then challenged the mice with the unmatched H1N1 virus that caused the 1918 Spanish flu. This virus caused the most devastating pandemic of the last century, killing over 40 million people worldwide. While all the control mice died by day 8 after being challenged with a lethal dose of the virus, all the animals vaccinated with the consensus H1HA vaccine survived (100% protection) to the end of the experiment. In addition to measuring survival, the researchers observed significant protection from infection-associated morbidity in the H1HA immunized mice.

Dr. Sardesai stated, "Influenza viruses mutate and develop multiple divergent strains very rapidly, allowing them to potentially escape protection afforded by existing vaccines. On the other hand, developing influenza vaccines effective against these newly emerging, or genetically unmatched, strains has been challenging. These animal data are encouraging and suggest that we could effectively cross-protect against unmatched influenza strains, even against a pandemic virus such as the one that killed millions of people in 1918. We are now testing our SynCon™ H1N1-targeted vaccines against the newly emergent swine-origin influenza A (H1N1).”

Dr. J. Joseph Kim, now Inovio’s Chief Executive Officer, said, "The ability to universally protect people from influenza strains that are not exactly like the ones that make up the existing vaccines we have would be an important contribution to modern medicine. We are enthusiastic about the potential of our vaccine approach and results to date, and we have filed an IND for VGX-3400, a candidate vaccine targeting avian influenza H5N1. We look forward to moving Inovio’s first influenza program into the clinic.”

VGX Pharmaceuticals, which merged with Inovio Biomedical on June 1, 2009, and its collaborators at the University of Pennsylvania developed the Company’s novel SynCon™ technology to design DNA-based vaccines with the capability to provide protection against unmatched sub-types and strains of pathogens. Using the SynCon™ technology, the scientists created universal influenza vaccines targeting both seasonal and avian influenza strains. VGX Pharmaceuticals created a set of SynCon™ DNA vaccines based on influenza HA, NA, and NP proteins from strains H1N1, H2N2, H3N2, and H5N1. This designer approach can potentially allow Inovio to rapidly develop a universal influenza vaccine containing DNA targeting all these strains simultaneously by formulating the individual component plasmids together against these target strains which make up the majority of seasonal and pandemic influenza.

About Inovio Biomedical Corporation

Inovio Biomedical is engaged in the discovery, development, and delivery of a new generation of vaccines, called DNA vaccines, focused on cancers and infectious diseases. The company’s SynCon™ technology enables the design of DNA-based vaccines better-targeted to desired immune system mechanisms and capable of providing cross-protection against evolving, unmatched strains of pathogens such as influenza. Inovio’s electroporation DNA delivery technology uses brief, controlled electrical pulses to increase cellular DNA vaccine uptake. Initial human data has shown this method can safely and significantly increase gene expression and immune responses. Inovio’s clinical programs include HPV/cervical cancer (therapeutic) and HIV vaccines. An IND has been filed for an avian influenza vaccine. Partners and collaborators include Merck, Tripep, University of Southampton, University of Pennsylvania, and HIV Vaccines Trial Network. Inovio’s product candidates and technologies are protected by an extensive global intellectual property portfolio. More information is available at http://www.inovio.com

erschienen am 02.06.2009 um 07:00 Uhr

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Thursday, October 2, 2008

METHODS OF ENHANCING IMMUNE RESPONSE USING ELECTROPORATION-ASSISTED VACCINATION AND BOOSTING

(WO/2008/063555) METHODS OF ENHANCING IMMUNE RESPONSE USING ELECTROPORATION-ASSISTED VACCINATION AND BOOSTING

Latest bibliographic data on file with the International Bureau
Pub. No.:
WO/2008/063555
International Application No.:
PCT/US2007/024051
Publication Date:29.05.2008 International Filing Date:16.11.2007
IPC: A61K 39/00 (2006.01)
Applicants:GENETRONICS, INC. [US/US]; 11494 Sorrento Valley Road, San Diego, CA 92121-1318 (US) (All Except US).
MATHIESEN, Iacob [NO/NO]; 11494 Sorrento Valley Road, San Diego, CA 92121-1318 (US) (US Only).
TJELLE, Elisabeth, Torunn [NO/NO]; 11494 Sorrento Valley Road, San Diego, CA 92121-1318 (US) (US Only).
KJEKEN, Rune [NO/US]; 11494 Sorrento Valley Road, San Diego, CA 92121-1318 (US) (US Only).
RABUSSAY, Dietmar [AT/US]; 11494 Sorrento Valley Road, San Diego, CA 92121-1318 (US) (US Only).
LIN, Feng [CN/US]; 11494 Sorrento Valley Road, San Diego, CA 92121-1318 (US) (US Only).
Inventors:MATHIESEN, Iacob; 11494 Sorrento Valley Road, San Diego, CA 92121-1318 (US).
TJELLE, Elisabeth, Torunn; 11494 Sorrento Valley Road, San Diego, CA 92121-1318 (US).
KJEKEN, Rune; 11494 Sorrento Valley Road, San Diego, CA 92121-1318 (US).
RABUSSAY, Dietmar; 11494 Sorrento Valley Road, San Diego, CA 92121-1318 (US).
LIN, Feng; 11494 Sorrento Valley Road, San Diego, CA 92121-1318 (US).
Agent:CHAMBERS, Daniel, M.; Biotechnology Law Group, 527 N. Hwy. 101, Suite E, Solana Beach, CA 92075-1173 (US).
Priority Data:
60/859,724
17.11.2006
US
Title: METHODS OF ENHANCING IMMUNE RESPONSE USING ELECTROPORATION-ASSISTED VACCINATION AND BOOSTING
Abstract:
Disclosed are methods of enhancing immune responses. Such methods involve the administration of vaccine compositions to different tissues to elicit an enhanced immune response. The enhanced response arises from the vaccination and boosting route of administration in two separate patient tissues, for example, by first administering a priming vaccination into skin and later administering a boost vaccination in muscle. In each case, priming and boosting, the administration of the vaccine composition is preferably carried out using contemporaneous electroporation-assisted delivery of the antigenic agent.


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Tuesday, September 30, 2008

A DNA-based vaccine shows promise against avian flu

Posted: September 30, 2008

Though it has fallen from the headlines, a global pandemic caused by bird flu still has the United States’ Centers for Disease Control and Prevention on high alert. Yet, to date, the only vaccines that have proven even semi-effective are produced in chicken eggs, take five to six months to prepare and act against a single variant of the H5N1 virus, which mutates incredibly quickly. Now, new research by scientists in New York and Taiwan has led to a vaccine with the potential to stop most strains of H5N1 flu viruses in their tracks.

David D. Ho, Rockefeller’s Irene Diamond Professor and scientific director of the Aaron Diamond AIDS Research Center, together with his colleagues at Taiwan’s Academia Sinica, has built a vaccine that stimulates immunity to a broad range of H5N1 viruses in mice by using DNA rather than dead virus particles grown in eggs. Such a vaccine, which consists of plasmid DNA that’s been genetically modified to elicit specific immune responses, is much easier to rapidly modify and produce — critical advantages when racing to prevent an epidemic.

Ho and his collaborators first had to address virus specificity: Because H5N1 viruses are incredibly diverse, and mutate fast, the researchers created a consensus sequence that incorporated all of the conserved parts of the gene encoding the virus’s outer protein. Then they had to figure out how to deliver it.

This is where DNA vaccines often fail. They aren’t very good at making sure the DNA gets where it needs to go. To solve this problem, Ho and his colleagues turned to electroporation, a technique that is just beginning to gain traction in the vaccine world and that, according to preliminary studies, helps increase uptake of the vaccine. By combining their consensus-sequence vaccine with a small electric stimulus, the researchers found that their mouse subjects responded with an incredibly broad immune reaction.

“The immune responses directed to our DNA vaccine seem to be very broad,” Ho says. “It could be that the vaccine in its current form could protect against most of the H5N1 viruses out there.” And even if it can’t, he notes, if a different strain of H5N1 begins to circulate, it should only take a few days to obtain its genetic sequence and adapt the existing vaccine to fight it.

A version of the consensus vaccine is already being produced, Ho says, so that it can move into human clinical trials as quickly as possible. And a separate electroporation study is under way at The Rockefeller University Hospital, this one examining the effectiveness of electroporation combined with a DNA vaccine against HIV.

Proceedings of the National Academy of Sciences 105(36): 13538–13543 (September 9, 2008)

Contact: Zach Veilleux 212-327-8982
newswire@rockefeller.edu

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Sunday, September 14, 2008

Inovio Biomedical Achieves 75% Complete Response Rate in Preclinical Testing of DNA-Based Cancer Vaccine Using Its Electroporation DNA Delivery System

Positive Results from Inovio's Proprietary DNA Vaccine Development Program to Be Reported at Cancer Research Institutes Symposium

SAN DIEGO, Sep 14, 2008 (BUSINESS WIRE) -- Inovio Biomedical Corporation, a leader in enabling the development of DNA vaccines using electroporation-based DNA delivery, announced today that it achieved positive results from its proprietary research and development program for DNA-based cancer vaccines delivered using the company's electroporation-based DNA delivery technology. The pre-clinical study results showed that in mice with metastatic melanoma treated with a DNA-based therapeutic vaccine via intramuscular delivery, six of eight (75%) were tumor-free at the conclusion of the study.

Inovio's research and development program is assessing multiple DNA vaccine candidates against infectious diseases and cancer using its proprietary electroporation-based DNA delivery technology. This experimental therapeutic vaccine formulation for melanoma utilizes a regime including depletion of immune-dampening regulatory T-cells along with immune-stimulating genetic components. The combination of this vaccine with intratumoral delivery of IL-12 (independent clinical results of which have been previously reported by Inovio) improved the efficacy and tumor regression achieved by the vaccine. These data will be presented in a poster session entitled, "Regression of subcutaneous B16F10 melanoma following electroporation enhanced delivery of plasmids encoding xenogenic melanoma antigens and IL-12," at the Cancer Research Institute symposium, "Cancer Immunology and Immunotherapy 2008," being held at the Millennium Conference Center in New York City, September 15 -- 17, 2008.

Avtar Dhillon, MD, president and CEO of Inovio, said: "Our pipeline has to date consisted of DNA vaccine products being advanced by partners, for which we are fortunate. However, our aim has always been to also develop novel proprietary DNA vaccines, delivered via our electroporation technology, to stimulate robust T-cell responses and produce potent anti-cancer and anti-infectious disease activity. Our intention is to rigorously evaluate the potential of these new agents -- such as this melanoma vaccine and our recently highlighted preclinical universal influenza vaccine -- in animal models and move selected candidates into the clinic with the goal of meeting unmet medical needs and increasing our pipeline's value."

About Inovio Biomedical Corporation
Inovio Biomedical is focused on developing multiple DNA-based immunotherapies and DNA vaccines. Inovio is a leader in developing human applications of electroporation using brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical. Human data has shown that Inovio's electroporation-based DNA delivery technology 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's technology is protected by an extensive patent portfolio covering in vivo electroporation. More information is available at www.inovio.com.

SOURCE: Inovio Biomedical Corporation
Investors:
Inovio Biomedical
Bernie Hertel, 858-410-3101
or
Media:
Ronald Trahan Associates Inc.
Ron Trahan, 508-359-4005, x108

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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.

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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.

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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

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Why the merger?:

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