"VaxInnate: We're fast, cheap and easy," jokes CSO Alan Shaw (pictured, left). And that's just what the HHS likes about the company. Last month the agency granted the Cranbury, NJ-based developer a contract to support development of its new, faster approach to producing flu vaccines.The company's recombinant vaccine technology is based on combining influenza and bacteria proteins to stimulate a strong immune response to protect against the flu. "We attach a danger signal to an antigen for what we're going to make a vaccine for," explained Shaw in an interview with FierceVaccines. That danger signal prompts the body's immune system to fight the flu virus.
The approach prompted HHS to award VaxInnate a $117.9 million contract over three years, along with a possible two-year extension, for a total contract value of $196.6 million. The grant is part of the agency's larger effort to shore up the country's supply of influenza vaccines. In the mid-2000s, the federal government moved to secure egg-based vaccine manufacturing, putting its money into established technology to guarantee the vaccine supply. The next round of funding went into cell culture production, though that technique has its limitations as well. Its three awards for recombinant technology have been granted to Protein Sciences (2009), Novavax and VaxInnate.
The advantage of VaxInnate's technology, explains CEO Thomas Hofstaetter (pictured, right), is the ability to quickly make massive amounts of the vaccine, especially in the case of a pandemic. A 1000 liter fermenter can produce the bulk components for 200 to 400 million vaccines--enough to cover the whole population of the United States. It produces one vaccine component per run--a single fermentation takes about two weeks, so in six to eight weeks it's possible to produce a trivalent vaccine. And VaxInnate says they can have the vaccines ready in as little as three months, which is half as long as traditional egg-based manufacturing methods.
Prior to the funding, the developer had 46 employees, but has added 10 more in the past few weeks and plans to add another 10 in coming months. Most are biologists, although it's also seeking out immunologists, accountants and contract administrators. In addition to more staff, the HHS contract has given VaxInnate breathing room for two preclinical programs for malaria and dengue--both of which feature the same technology found in its flu vaccine. A Phase I trial for dengue is anticipated for 2013.
VaxInnate doesn't plan to go it alone; the company will be looking for partners to expand the reach of its business. "We're in the stage that we'll reach out to potential partners," explains Shaw. "Once our flu technology is on its way into the clinic, we will be looking at partnerships in emerging markets." The company is interested in making both its flu vaccine and core technology available globally through partnerships, VaxInnate added in a statement.