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Virtual venture brings adjuvants into the 21st century

By Joseph Harvey

In April 2013, VaxLiant was created in the US as a joint venture between biologics development firm Benchmark Biolabs and animal health products distributor AgriLabs. The venture is aiming to market its ready-to-use, custom vaccine adjuvants, with an eye on avian flu and other markets. Four months after its creation, Animal Pharm senior reporter Joseph Harvey met with both sides of the business in downtown Kansas City.

Adjuvants are not a new innovation. Dr Timothy Miller, co-founder of VaxLiant, said adjuvant technology has remained largely unchanged over the last 50 years. However, he believes the joint venture's ENABL system will be the technology that modernizes the way vaccines are delivered to animals and the speed with which they are created.

In short, VaxLiant has developed an adjuvant production platform which, when combined with DNA technology, can be applied to economically damaging transboundary diseases, including avian influenza, foot-and-mouth disease and African swine fever.

The key benefit of the ENABL technology is that it does not use live-virus or animal-origin material. This means manufacturers can produce vaccines more safely. The ENABL platform can reduce the amount of antigen used in a vaccine by around 5-20 times thus boosting both safety and efficacy.

Dr Miller is also the president of Lincoln, Nebraska-based Benchmark Biolabs, which has developed a portfolio of 15 ready-to-use ENABL adjuvants and the fully customizable Biomize antigen-delivery system. It is this technology that makes up the VaxLiant product portfolio. ENABL is available for use in both traditional and new vaccines for cattle, pigs and poultry.

The joint venture's sales and marketing experience is provided by St Joseph, Missouri-headquartered AgriLabs. The latter is led by president and chief executive Steve Schram – VaxLiant's other co-founder.

VaxLiant claims the ENABL adjuvants are able to reduce the effective dose of DNA virus vectored vaccines, reduce the number of booster inoculations for DNA vaccines and provide ready-to-use formulations. The technology also enables the delivery of a number of different adjuvants for a wide range of indications.

Mr Schram said the ENABL system has demonstrated sufficient stability compared to existing delivery solutions such as DNA vaccines, which currently require high levels of antigen to be effective, making them expensive and impractical for widespread commercial use.

VaxLiant's versatile adjuvant technology aims to allow vaccine manufacturers to create products to treat specific disease outbreaks. The formulations used by VaxLiant are adaptable to various delivery methods, such as the transdermal, aerosol and oral routes.

As the ENABL technology is derived from DNA, there is no problem with the differentiation of infected animals from those which have been vaccinated (DIVA).

USDA boost

Shortly before Animal Pharm met VaxLiant, the company received a boost from the US Department of Agriculture Center for Veterinary Biologics (CVB). The CVB published guidelines for licensing production platforms using recombinant DNA. According to VaxLiant, this makes commercialization of a vaccine supported by the ENABL adjuvant more likely within the next three years.

"The new CVB guidelines identify the steps to take to receive approval of a 'production platform' – the process of consistently, safely manufacturing vaccines using recombinant DNA technology," said Mr Schram. "This means there is now a pathway for our ENABL vaccine platform to become USDA-licensed. This can lead to vaccines for avian influenza and other emerging diseases that are more practical and affordable than today's options, in about one-third of the time."

Mr Schram explained to Animal Pharm the ENABL technology's ability to be adopted for new strains of virus at quick speeds. He said conventional vaccine methods take around three years to develop and commercialize following an outbreak of a new strain of disease. Due to the ability to customize the ENABL platform, he said new adjuvant-supported vaccines for novel strains could be developed in a year. This benefit is immediately recognizable in the fight against the changing nature of avian influenza.

Avian flu opportunity

VaxLiant is currently seeking a strategic partner to fund development of its technology for the treatment of avian flu. According to the firm, around $120 million was spent on stockpiling vaccines during the 2005-2006 H5N1 avian flu outbreak that were provided too late to be used to treat humans and animals.

The firm believes current methods to shorten the cycle time for applications of the genetic database into vaccine production have not been commercially feasible. VaxLiant claims its adjuvant technology supports the genetic database and allows it to address new strains of influenza.

In presenting at the recent Kansas City Animal Health Investment Forum, VaxLiant predicted the avian flu market alone could be worth up to $80m for a potential commercial partner after five years of sale – an estimate Mr Schram branded conservative. This level of sales would represent around a 21% market share for the strategic partner.

Virtual venture

VaxLiant is a virtual company. The firm's staff, technology, know-how and revenues belong to Benchmark and AgriLabs.

Mr Schram said AgriLabs had had a relationship with Benchmark for around eight years before VaxLiant was born. He explained: "We are both private companies and over the years we had built up a certain amount of trust. Benchmark approached us about being a marketing partner for its adjuvant technology."

Instead of pursuing a regular commercialization agreement, the two companies decided to combine their strengths under the structure of a joint venture. Mr Schram said the firms chose to form a joint venture to allow the adjuvant business to move quickly in terms of product development and also in terms of management decisions.

Mr Schram said, while the concept of this type of collaboration is not new, it is becoming more popular. This trend is being driven by the economic benefits of having a virtual company.

Posted with permission of Animal Pharm, Informa Agra, Guardian House, 119 Farringdon Road, London, England EC1R 3DA,
+44 (0)20 7017 7500, www.animalpharmnews.com

 

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