The H5N1 Threat

According to the CDC, the highly pathogenic strain of avian influenza, known as H5N1, has caused millions of domestic poultry deaths in Asia over the past several years. There is a growing concern that the H5N1 virus will be able to gain the ability for efficient and sustained transmission among humans, which has the potential to cause an influenza pandemic with potentially high rates of illness and death worldwide. New research suggests that currently circulating strains of H5N1 viruses are becoming increasingly capable of causing disease (pathogenic) in animals. For example, one study found that ducks infected with H5N1 virus are now shedding more virus for longer periods even without symptoms of illness.

Human H5N1 Cases

The WHO has reported human cases of avian influenza A (H5N1) in Asia, Africa, the Pacific, Europe and the Near East. Indonesia and Vietnam have reported the highest number of H5N1 cases to date. Overall mortality in reported H5N1 cases is approximately 60%. The majority of cases have occurred among children and adults aged less than 40 years old. Mortality was highest in cases aged 10-19 years old. Studies have documented the most significant risk factors for human H5N1 infection to be direct contact with sick or dead poultry or wild birds, or visiting a live poultry market. Most human H5N1 cases have been hospitalized late in their illness with severe respiratory disease. To date, there have been 571 confirmed cases of H5N1 worldwide.

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Our Cholera Vaccine Candidate

Our lead product, PXVX-0200, is a single dose, oral, live, attenuated vaccine against cholera entering Phase 3 clinical trials. This vaccine is a relatively low risk, high reward product, having been previously approved and marketed in six countries under the brand name “Orochol.” This product’s rapid onset of protection makes it ideal for travelers to cholera endemic areas. Given its rapid onset of protection, this vaccine is potentially invaluable in epidemic outbreaks where the disease spread needs to be controlled quickly. PXVX-0200 will form the basis of our traveler’s vaccine portfolio if approved for marketing within the next few years.

Our Bird Flu (H5N1) Vaccine Candidate

Our second major product, PXVX-0103, is a single dose, oral, live adenoviral-based vaccine against avian influenza (H5N1) or “bird flu.” This vaccine will enter Phase 2 clinical trials in 2012, and represents a new paradigm for oral vaccines. This vaccine has demonstrated both cellular and humoral (antibody) immune efficacy. PXVX-0103 will be marketed to governments for influenza pandemic defense.

The PaxVax Technology Platform

PaxVax is leveraging our proprietary adenoviral vaccine platform, novel cell substrates for the production of vaccine virus, and our unique downstream processes to ensure rapid, scalable, low cost oral vaccines. We strive to meet the “ideal” specification for vaccines: not only safe and effective, but without the need of refrigerators, needles, syringes, or trained medical personnel, that rapidly induces broad, long-lasting immunity with a single dose and at low cost.

Our vision for affordable and accessible vaccines is propelled by the following strategies:

Proven Efficacy & Safety

The U.S. Military has been using oral adenovirus vaccines for nearly 30 years with excellent safety and efficacy in over 10 million recruits.

“Plug & Play” Science

Adenovirus-based vaccines can be rapidly created against any protein antigen and grown quickly to improve manufacturing timelines.

Low Cost Manufacturing

Proprietary cell substrates and all disposable processes yield rapid, scalable manufacturing.

Bucking the “Cold Chain”

Novel formulations and simultaneous spray drying and enteric coating provide room temperature stability.

Technology Validation and Financial Support

We have advanced our R&D portfolio of Ad4-based vaccines with the financial support of the Wellcome Trust, as well as NIAID and DAIDS within the NIH. These institutions support clinical and preclinical work on our H5N1, anthrax and HIV vaccine candidates. We also received a Grand Challenge Grant from the Bill and Melinda Gates Foundation for a vaccine candidate for use in polio eradication. To date, we have raised over $50 million in funding from various foundations and government agencies to leverage our investments from venture capital and private equity. We actively pursue grant and contract support for our vaccine candidates, particularly for endemic diseases in developing countries and biodefense technology.