Philadelphia's Wistar Institute said last week that it has obtained a US patent for a synthetic vaccine technology with the potential to be developed into a universal flu vaccine that could eliminate annual flu shots and protect against pandemics.
Wistar said it is now seeking a corporate partner to license and develop the vaccine, which has been tested in animals and is currently in prototype form.
The newly awarded patent, US No. 7,527,798, is entitled "Composition and method for preventing or treating a virus infection."
The patent pertains to technology developed by Walter Gerhard, a professor emeritus and former professor of immunology at Wistar, and Laszlo Otvos, formerly an associate professor of immunology at Wistar. Otvos is currently research professor and director of drug development at the Sbarro Institute of Cancer Research and Molecular Medicine at Temple University.
According to Wistar, the vaccine prototype contains an engineered peptide that mimics a viral coat protein called M2 that remains largely constant from year to year.
In contrast, current flu vaccines trigger an immune response to a pair of viral-coat proteins known as hemagglutinin and neuraminidase, which mutate constantly and are the reason the flu vaccine must be changed every year to target the appropriate subtypes.
Wistar said it believes that a vaccine targeting M2 has the potential to protect against all strains of the influenza A virus — including the H1N1 swine flu subtype.
Other academic laboratories and companies have been developing vaccines that target the M2 protein. But development of a universal vaccine has been slow because humans do not mount a strong immune response against M2.
"What we've done is taken the M2 and stimulated the body to make something like M2, and linked it to some peptide that will then take this molecule and present it to the right immune cells for a good stimulus," Meryl Melnicoff, director of business development for Wistar, told BTW last week.
"The unique thing is we've modified the antigen in such a way to create a good immune response in mice," she added.
In preclinical studies Gerhard and Otvos administered the experimental vaccine intranasally to mice. After vaccination, the scientists noted a steep rise in M2-specific antibodies in blood samples, and the mice exhibited protection against influenza virus infection of the respiratory tract. The findings were published in the June 2, 2003, issue of the journal Vaccine.
The '798 patent is based on the research behind that paper, Melnicoff said.
She said that development of the prototype vaccine stalled "for a variety of reasons I'd rather not get into," but added that now "some of the technological hurdles are reduced. Having an issued patent puts you in a better position for partnering. People we have talked to in the past we are talking to again."
Melnicoff also said that Wistar is now "going to kick up the marketing on this a little bit" because of the stronger IP position. It may also have a few other factors working in its favor to attract a suitor.
First, the timing of the patent issuance coincides — unintentionally, according to Melnicoff — with the recent swine flu outbreak, which has brought new influenza vaccination technologies to the top of public health priority lists.
In addition, Melnicoff said that large pharmaceutical companies have in recent years been moving more heavily into the vaccine market, citing as examples Pfizer's recent acquisition of Wyeth; a stronger vaccine play by Novartis in recent years; and vaccine success stories such as Merck's Gardasil vaccine for human papillomavirus.
"Things that were once very low-priced commodities are now more complex to make and getting higher prices in the market," Melnicoff said. "If you look at biotech, like any industry it kind of goes through cycles. Now vaccines are back in companies' sweet spots. Companies are reporting good sales."
She also said that the Wistar technology has the potential to be a universal vaccine and thus "certainly would command a premium price."
Wistar may also benefit from the fact that it, along with the Children's Hospital of Philadelphia, was involved in developing the technology that serves as the basis for Merck's rotavirus vaccine Rotateq, which last year generated $665 million in sales, 27 percent over 2007.
It is unclear what Wistar's stake in Rotateq is, as details of its agreement with Merck are confidential, Melnicoff said.
However, in 2005 Wistar sold a portion of its anticipated worldwide royalty revenues from the vaccine to an affiliate of the Paul Royalty Fund for $45 million. Likewise, in 2007, CHOP sold its worldwide royalty interest in Rotateq to Royalty Pharma for $182 million.
According to Melnicoff, the first research and patent on the rotavirus vaccine technology occurred in 1988, and Rotateq was approved in 2006. "That's just an example of the length of time it takes for an early-stage tech to become a product," she said.
Wistar is now seeking a partner to license the influenza vaccine "or do some collaborative research with us," because as a basic research institute, Wistar is ill-equipped to conduct human tests of the vaccine.
The institute also entertained the idea of starting up a company around the technology, but Gerhard's recent retirement might be detrimental to such a venture. "If we had the right CEO, it's something that could be in a startup," Melnicoff said. "But we haven't really pushed that. If there's an entrepreneur that's developed vaccines in the past it might be a good fit."