VLA15 is the only active Lyme disease vaccine programme in clinical development today, and covers six serotypes that are prevalent in North America and Europe
Valneva SE (Valneva), a speciality vaccine company, and Pfizer have announced a collaboration to develop and commercialise Valneva’s Lyme disease vaccine candidate VLA15, which is currently in Phase 2 clinical studies.
VLA15 is the only active Lyme disease vaccine programme in clinical development today and covers six serotypes that are prevalent in North America and Europe. The investigational multivalent protein subunit vaccine, VLA15, targets the outer surface protein A (OspA) of Borrelia, an established mechanism of action for a Lyme disease vaccine. OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick. VLA15 has demonstrated strong immunogenicity and safety data in pre-clinical and Phase 1 studies. The program was granted Fast Track designation by the US Food and Drug Administration (FDA) in July 2017. Valneva has completed patient enrolment and follow-up for two Phase 2 studies of its Lyme disease vaccine candidate, in more than 800 people. Valneva expects to report the first Phase 2 results in mid-2020.
Valneva and Pfizer will work closely together throughout the development of VLA15. Valneva is eligible to receive a total of $308 million cash payments consisting of a $130 million upfront payment, $35 million in development milestones and $143 million in early commercialization milestones. Under the terms of the agreement, Valneva will fund 30% of all development costs through completion of the development program, and in return, Pfizer will pay Valneva tiered royalties starting at 19 per cent. Pfizer will lead late-stage development and have sole control over commercialisation.
This transaction is subject to customary closing conditions and clearances under antitrust law, including the Hart-Scott Rodino Antitrust Improvements Act.
Lazard served as exclusive financial advisor to Valneva and Dechert LLP served as Valneva’s legal counsel for the collaboration.