No vaccine for Lyme disease is available since GlaxoSmithKline took one off the market in 2002. Valneva intends to fill the gap by advancing a candidate that’s now phase 2-ready, and it could mean a comeback for GSK through a deal it inherited from Novartis.
Valneva recently reported positive phase 1 interim data for its candidate, VLA15. At the highest, adjuvanted dose group, the vaccine induced antibody responses of 71.4% to 96.4% against the outer surface protein A of six serotypes of Borrelia bacteria, which is passed to humans by ticks to cause the illness.
No serious adverse events and no cases of arthritis were observed. GSK once marketed LYMErix, which covered only one serotype of the bacteria, but voluntarily withdrew it in 2002 because of an alleged connection to arthritis.
With that positive data, Valneva now looks to launch a phase 2 in the second half of 2018. It will be carried out in Lyme-endemic regions in the U.S. and Europe, and include subjects previously infected with the bacterium. Moreover, a few subjects in phase 1 will be re-enrolled to receive a booster dose. The plan is to see whether such a regimen is necessary and to help further understand the shot’s safety and immunogenicity.
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In an email to FierceVaccines, a Valneva spokesperson said the biotech estimates it'll cost $350 million to get the vaccine to the market. The size of investment is almost impossible for Valneva to bear on its own, and the company is looking for a partner. That could be GSK. Commercially, Valneva figures the annual Lyme disease vaccine market is worth €700 million to €800 million.
Though GSK bowed out of the market in 2002, it could make a comeback through a strategic alliance it inherited from its massive Novartis asset swap via a 2007 deal Novartis originally signed with Intercell, which merged with Vivalis to form Valneva in 2013. GSK has an option to take over the vaccine upon completion of phase 2 and pay Valneva milestones and royalties. The pair can also take a co-development, co-marketing path to share both costs and profits related to the vaccine.
Of course, Valneva may not realize its sales ambition without cost-sharing government programs or insurance, and management appears confident there’s an unmet medical need to warrant coverage.
“In those [endemic] regions we would expect the health authorities and reimbursement groups to be very supportive of treatment on the NHS. In the U.S. we would expect for some regions, health insurance companies would cover the vaccine,” Valneva CFO David Lawrence told The Telegraph in an interview. He also said once regulatory bodies get comfortable with VLA15’s safety profile, Valneva plans to move down the age group to children as young as 2. The company spokesperson said Valneva will pursue that expansion through a typical age de-escalation process, and it aims to do it soon after the development of the adult vaccine.
Lyme is the most common tick-borne disease in the Northern Hemisphere, with about 300,000 cases reported to the U.S. CDC each year and another 200,000 seen in Europe. Valneva argues that the real number could be bigger because many infections go undiagnosed.
Editor's Note: This story has been updated with additional comments from Valneva.