[Updated: 7:10 am PT] Sometimes little biotech companies hit the wall, and need a jolt from new management, new investors, and even a change of scenery to see if their technology is ever going to pan out. Mymetics is one of those classic biotech stories, of a little vaccine company heading West to reinvent itself.
The Switzerland-based company, which is publicly traded on the over-the-counter exchange where biotechs often go to die, is announcing today it is cleaning house with a new management team, and a new board led by a couple veterans of Seattle-based Dendreon (NASDAQ: DNDN). Mymetics has enlisted Dendreon founder Christopher Henney as its new chairman, and signed up Grant Pickering, a Henney protégé formerly with Dendreon and Kleiner Perkins Caufield & Byers, as the new CEO. Four members of the company’s existing board have resigned, and plans are in motion to move the company to either San Francisco or Seattle, and raise new money to develop a lead vaccine candidate for respiratory syncytial virus (RSV).
Mymetics has a head-spinning corporate history, which I won’t belabor here, other than to say it has burned through 49 million euros since being incorporated in 1994, it has no vaccines on the market, and it had only 382,000 euros left heading into this year (about $500,000). Its biggest investor is from an entity I’ve never heard of, on Guernsey, an island in the English Channel. It does have big-name scientific advisors from the University of Pennsylvania, Harvard Medical School, and the Fred Hutchinson Cancer Research Center.
More importantly, what attracted Pickering and Henney, are virosomal vaccine technologies to trigger the body to produce protective antibodies in the mucosal membranes that represent the body’s first line of immune defense. The initial plan is to test this technology against one of the most lucrative, and competitive, vaccine opportunities in the world—respiratory syncytial virus (RSV). There’s no current vaccine for this infection that hits almost all children by their second birthday and ends up hospitalizing as many as one in 50 kids, according to the Centers for Disease Control & Prevention.
Essentially, Pickering and Henney are betting that this little company with eight full-time employees, and a stock price of 6 cents, could become something big with the right leadership, and money behind it.
“Chris [Henney] and I aren’t going to toil in the backwaters of the business world. We have big plans,” Pickering says. “We want to build a great company, and there’s a real void in the mid-cap space for new vaccine companies.”
Henney, 71, the co-founder of Immunex, Icos and Dendreon, says he became interested in Mymetics after being introduced to it by a New York investor. Despite the lack of a NASDAQ listing, and the lack of cash, he liked the science. “It was purely a scientific decision,” Henney says. “I knew of the [virosomal] technology in a general sense. But everybody I talked to thought this was the best rendition of that technology.” What it needed, he says, was a veteran vaccine executive like Pickering who could provide new direction, raise more money, and keep some of the key scientific members of the team on board.
Pickering, 44, settled on this new venture last month, after spending the previous 14 months as an executive-in-residence at Kleiner Perkins, where he looked over a wide variety of investment opportunities for drugs, vaccines, and even health IT companies.
The big technology idea at Mymetics comes from Toon Stegmann, a former director of vaccine research at Netherlands-based Crucell, which was acquired by Johnson & Johnson last year for $2.4 billion. Stegmann’s work is in the field of virosome-based vaccines, which essentially utilizes components of a viral membrane to make vaccines. By extracting the infectious RNA from a virus, and combining the viral membrane components with an immune-boosting compound called an adjuvant, researchers hope that virosomal vaccines can spark efficient immune reactions against specific invaders. The approach is thought to have advantages over the traditional whole-killed, or live-attenuated vaccines, in which viruses are killed and injected, or weakened and injected, to help the immune system recognize invaders that need to be attacked.
The approach isn’t entirely new, as there are two commercial flu vaccines that are made through virsomal means, and another vaccine for hepatitis A, Pickering says.
What Mymetics has that’s different, he says, is a virosomal vaccine platform technology that made it possible to make the viral membranes soluble on a large scale. The drawback with the approach in years past, he says, was that in order to make the first-generation virosomal vaccines soluble, Mymetics used a manufacturing process that required a detergent that needed to be filtered away from the vaccine with beads. That process sometimes caused degradation of the viral proteins that were supposed to spark an immune response, Pickering says. The technical issue has now been overcome, he says, as Mymetics has gotten a new technology for using short-chain phospholipids which make its vaccine candidates soluble without using detergents. By going that route, Mymetics keeps the desired immune-sparking properties of the virosome, allows the vaccine to be combined with immune-boosting adjuvant compounds, and enables the company to manufacture its vaccines at large scale.
“It’s the combination of technologies that inspired Henney and I to join forces,” Pickering says.
Mymetics is aiming high with its lead development program, with a vaccine against RSV. While there’s no vaccine for this common infection, AstraZeneca’s MedImmune unit has made a fortune over the past decade with an antibody treatment called pavilizumab (Synagis). MedImmune has sought to build on that momentum with an vaccine to prevent RSV infection, and as many as 10 other companies are vying to make an RSV vaccine, according to the latest annual report from a competitor in the field—Rockville, MD-based Novavax (NASDAQ: NVAX).
The business opportunity in RSV is obviously big, since it is ubiquitous in children, and leads to an estimated 200,000 infant deaths a year, according to research published in the Lancet in 2010.
The Mymetics offering hasn’t yet entered clinical trials, and it isn’t expected to get there until 2013, according to the company’s latest annual report. But Mymetics has focused on this lead candidate, Pickering say, because he believes its virosomal packaging will enable it to vaccinate all kinds of people, young and old. MedImmune’s RSV vaccine candidate is a live-attenuated form of the virus, it is only for infants, and is in mid-stage clinical trials with “a long way to go,” he says. [Corrected: 7:10 am PT] NovaVax also recently presented what Pickering calls “some great data” about the health economic need for an RSV vaccine. “There’s still a lot of room to maneuver for a vaccine that’s effective,” Pickering says. [Editor’s note: An earlier version said Pickering referred to great data from clinical trials of NovaVax’s vaccine candidate, but he was referring to its health economic study.]
But if MedImmune has a long way to go, Mymetics has an even longer way to go. Its RSV vaccine candidate is still in preclinical testing, and its most recent experiments in rats and mice from last year shows it was able to trigger mucosal antibodies, and antibodies in the bloodstream, with a reduced dose of immune-boosting compounds. The next step is “to prepare a stable product that will be used for a Phase I trial in 2013,” Mymetics said in its annual report filed on March 29.
The company’s second product in development is a vaccine for HIV—a field that has long stumped researchers and vexed biotech companies. Mymetics has shown an ability to completely protect monkeys who were directly exposed to the HIV virus, and it believes it has a differentiated approach through its focus on a marker called GP41 instead of the GP120 target that many other vaccines have aimed at in the past, Pickering says. Mymetics has some data from a Phase I human study that shows the HIV vaccine was safe and sparked some immunity, but he said this is a program he’ll seek outside grant funding to support. “It’s key for a little company to be smart about our money. It’s hard for a small company to tackle such a huge need like an HIV vaccine,” Pickering says.
Pickering’s first main task will be raising money for all these new plans, but finding a new home on the West Coast is also high on the to-do list. Both San Francisco and Seattle’s biotech hubs have the kind of immunology-minded employees and advisors that a company like Mymetics wants to be close to, and he wasn’t tipping his hand on where the company will end up. Even though Mymetics is only worth $18 million today, Pickering says he can envision it becoming an independent vaccine company that could last.
“I had the good fortune of looking at a number of interesting things at Kleiner Perkins, and could have taken a variety of different career paths, in health IT, or with more traditional therapeutics, like I did at J&J and GSK, and another company I worked at before Dendreon,” Pickering says. “But I was always holding out hope for the right vaccine opportunity, because of the impact they can have on public health.”
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