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High-value vaccine investment
August 2009
by David Hutton  |  Email the author
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BURLINGAME, Calif.—Juvaris BioTherapeutics Inc., a biotechnology company developing adjuvanted vaccines for infectious diseases, recently announced a collaborative agreement with Antigen Discovery Inc. (ADi). Juvaris officials say the company will use ADi's high-throughput protein microarray screening system to help it discover disease-specific antigens to fuel Juvaris' vaccine pipeline.

Juvaris will sponsor research for multiple disease targets and pay Irvine-based ADi upfront payments, development milestones and royalties on licensed products in exchange for full product development rights to all fields except diagnostics, which will belong to ADi.

Financial details of the collaboration were not disclosed.

Grant Pickering, president and CEO of Juvaris, said obtaining access to the ADi platform is a "transformational event for Juvaris," and will enable to company to develop proprietary, high-value vaccines. ADi's antigen discovery platform involves assaying the entire proteome of a disease target to identify every possible protein antigen. The selected antigens are derived from reactive antibodies generated by infected individuals and therefore mimic the presence, accessibility and antigenicity of relevant proteins from the particular pathogens in humans.

The system will be used to identify protective antigens using sera from patients infected with particular target diseases, Pickering says.

"Juvaris' adjuvant, JVRS-100, has been shown in the clinic to enhance both antibody and T-cell mediated immune responses, which will be necessary to produce immunity to many of the infectious disease targets that have not been addressed via vaccination," he explains. "The ADi antigen discovery platform is efficient, productive and has been validated across a number of infectious diseases. The ADi methodology results in the discovery of immunodominant antigens that contain either conformational or linear epitopes. Having the ability to screen the entire proteome of highly-complex pathogens using full proteins versus DNA fragments allows for the discovery of conformational epitopes, which are the highest quality antigenic targets for vaccine development, as well as rare antigens that are overshadowed by immunodominant antigens but could provide breakthrough protective immunity when used as vaccines."

"Juvaris will evaluate the resulting antigens for immunogenicity and efficacy in preclinical models of the appropriate infectious disease," Pickering adds. "Antigens which confer protection following vaccination will be evaluated for suitability for product development."

Keith B. Hoffman, head of business development at ADi, says the company is quite happy to partner with Juvaris due to its personnel, financial backers and impressive development history with vaccines and related therapeutics.

"Juvaris has the entire vaccine development engine, ADi has the antigen content—a perfect fit," he says. "After screening thousands of patient samples, we have proven the utility of our platform across multiple infectious diseases. ADi's antigen discovery platforms leverage genomics and proteomics advances to provide Juvaris with the most comprehensive and powerful leads for their vaccine formulations. We very much look forward to working with Juvaris to discover important antigens to facilitate not only vaccine development to prevent or treat disease, but also diagnostics to manage disease."

According to Hoffman, the process distinguishes antigens that best stimulate the immune system and are thus ideal targets for vaccine and diagnostic development. ADi has successfully identified and refined more than 1,500 immunodominant and serodiagnostic antigens via the screening of thousands of human subjects across dozens of pathogens.
 
"On ADi's proteome chips, each specific spot represents a known protein expressed from a corresponding ORF expression plasmid," he says. "Once a positive spot is identified, we know instantly which gene it is, and what specific plasmid clone to use to proceed to next validation step."

Hoffman adds that they do not pre-select or purify, and the entire proteome is mined.
"What this all means is that ADI's discovery platform is the most effective and comprehensive way to screen immune responses against pathogen proteomes for vaccine antigen discovery," he says. "The technology will also likely be useful in facilitating other aspects of vaccine development, for example; evaluating vaccine formulations and/or adjuvants, designing vaccination protocols, pre-selecting and monitoring clinical trial subjects, etc. As our relationship with Juvaris yields vaccine leads, we hope that the collaboration may expand into some, or all, of the additional areas."

Infectious diseases result in a quarter of worldwide deaths each year. The majority of diseases where vaccines have not been developed to date are highly complex organisms that require novel technologies, such as ADi's, to facilitate discrimination of protective antigens from a large number of non-protective antigens.

Juvaris currently boasts a robust pipeline with two clinical development programs employing its adjuvant, JVRS-100, that Pickering says the company believes will produce more effective seasonal and pandemic influenza vaccines.

"The seasonal flu vaccines available today are largely ineffective in the elderly, as they produce only modest antibody responses," he notes. "As a result, 90 percent of the morbidity and mortality that occurs each year from flu translates into tens of thousands of deaths due to influenza. T-cell responses from natural infection correlate with protection from influenza in the elderly. Our adjuvant has shown the ability, in the clinic, to produce T-cell mediated immunity, which may result in the production of a seasonal flu vaccine that would protect the elderly."

Moreover, Pickering points out that the pandemic influenza vaccine that is stockpiled for a potential avian flu outbreak requires multiple doses of large amounts of antigen and is not effective against the strains of avian flu that have been circulating for the past few years. 

"The CDC showed that our adjuvant, when combined with the stockpiled vaccine in pre-clinical studies, was able to confer single-dose protection against the matched and drifted strains (currently circulating) of avian flu using less than 10 percent of the current antigen," he says.

Juvaris' proprietary vaccine pipeline consists to two highly-promising vaccines, including a prophylactic HSV-2 Vaccine combining its adjuvant, JVRS-100, with all of the critical antigens to prevent viral entry at every critical phase—initial attachment, receptor binding and fusion.

Juvaris also has a universal flu vaccine combining its adjuvant, JVRS-100, with conserved Flu A and Flu B sequences to prevent serious infection with whatever circulating strains may exist from year-to-year. 

"Currently, seasonal flu vaccines require annual modification in anticipation of the upcoming circulating strains," Pickering says. "This predictive aspect results in mismatched vaccine strains every few years, which produces substantially higher morbidity and mortality, which could be averted with the incorporation of a universal flu vaccine."
 
 
Code: E080921

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