French speciality vaccine company Valneva has partnered with Pfizer for the development and commercialisation of Lyme disease vaccine candidate, VLA15.
Valnev’s VLA15 is a multivalent protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia. OspA is one of the most dominant surface proteins expressed by the bacteria within a tick.
The vaccine covers six serotypes prevalent in North America and Europe. In preclinical and Phase I studies, VLA15 yielded strong immunogenicity and safety data, said the companies.
VLA15’s programme secured fast track designation by the US Food and Drug Administration (FDA) in July 2017; it is currently in Phase II trials.
Valneva concluded patient enrolment and follow-up for two Phase II studies in more than 800 participants. Valneva expects the initial Phase II data in mid-2020.
Pfizer Vaccines global president Nanette Cocero said: “As both a research company, and a manufacturer of pediatric and adult vaccines including a vaccine for tick-borne encephalitis in Europe, we believe that Pfizer’s vaccine heritage, scientific expertise, and global commercial capabilities will help allow the VLA15 programme to reach its maximum potential in helping protect children and adults from Lyme disease.”
Valneva and Pfizer intend to co-develop and commercialise the Lyme disease vaccine candidate.
Valneva may receive a total of $308m in cash, including $130m upfront payment, $35m in development milestones, and $143m in early commercialisation milestones.
The company will fund 30% of all development costs until completion of the development programme and will receive royalty payments from Pfizer.
Pfizer will lead late-stage development and be solely responsible for commercialisation.
Meanwhile, Pfizer is also working with BioNTech for the development of a vaccine against Covid-19 infection.