If you’re looking for a Lyme disease vaccine, you can choose from among several—for your dog. A vaccine for humans hasn’t been available for years and few companies have tried to fill that void. Valneva has advanced its Lyme vaccine candidate to mid-stage clinical testing, and the company now has the help of drug giant Pfizer to continue its development.
The companies announced on Thursday an agreement to take the Valneva vaccine candidate, VLA15, through late-stage clinical testing, and, if approved, commercialization. Pfizer (NYSE: PFE) is paying Saint Herblain, France-based Valneva $130 million up front to start the partnership.
Lyme disease is caused by the bacterium Borrelia burgdorferi, which spreads to humans from tick bites. That bite develops into a trademark bulls-eye rash on the skin. Untreated, the infection can spread to the joints, the heart, and the central nervous system. The Centers for Disease Control and Prevention says 30,000 cases in the US are reported to the agency each year, though it adds that the true number of cases is estimated to be 10 times higher.
The Valneva Lyme vaccine’s antigen—the component that elicits an immune response—is derived from outer surface protein A (OspA) of Borrelia. This antigen causes the immune system to produce antibodies. In a tick infected by Borrelia, the bacteria go to the salivary glands. A bite transmits those bacteria to a human. But in someone who has been vaccinated by VLA15, the blood—and the antibodies within it—are ingested by the tick, Valneva CEO Thomas Lingelbach tells Xconomy. The antibodies get to work in the tick’s gut before the bacteria reach its salivary glands.
“Some people say that OspA vaccination is vaccinating the tick,” Lingelbach says. “You vaccinate the human… but the killing effect happens in the tick.”
OspA has previously been validated as a Lyme vaccine target. It’s the same one used in vaccines for dogs. It’s also the target for LYMErix, a Lyme disease vaccine for humans developed by GlaxoSmithKline (NYSE: GSK) predecessor SmithKline Beecham. The FDA approved LYMErix in 1998, but the product struggled commercially amid speculation that it caused arthritis as well as opposition from anti-vaccine groups. By 2001, the drug maker decided to withdraw LYMErix from the market.
Lingelbach says Valneva is going beyond LYMErix’s reach. Whereas LYMErix targeted only one of the bacterial strains that causes Lyme infection, the Valneva vaccine covers six. Those six strains are prevalent in North America and Europe, potentially providing broader protection on both sides of the Atlantic Ocean. In Phase 1 results reported last year, the vaccine produced an immune response with no safety problems. That immune response did not yet reach the maximum point, Lingelbach says. The company is now running two Phase 2 studies, expected to enroll up to 800 patients. One of the studies will determine the optimal dose to maximize the immune response. The other study will determine how many shots a patient will need and at what time intervals.
Valneva already markets two vaccines: Ixiaro, which protects against infection from Japanese encephalitis virus, and Dukoral, a cholera vaccine. The company says those products generated a combined €129.5 million (about $142 million) in revenue last year, with sales up more than 25 percent over the prior year. But Lingelbach says Valneva is a mid-sized vaccines company, and it has been looking for a partner capable of financing and conducting global Phase 3 tests expected to enroll 16,000 patients.
Pfizer already markets Prevnar, a pneumococcal vaccine that is a blockbuster seller. In addition to its experience with bacterial vaccines, Lingelbach says the pharmaceutical giant has the resources for late-stage clinical development and commercialization of the Valneva Lyme vaccine. According to the agreement, development costs will be split—30 percent to Valneva and 70 percent to Pfizer. The French company could gain $35 million in near-term development milestones. If the vaccine wins regulatory approval, Valneva stands to earn $143 million more in commercialization milestones. Pfizer will handle commercialization and will pay its partner royalties from the vaccine’s sales.