Valneva Announces Acceleration of Pediatric Development for Lyme Disease Vaccine Candidate

 

• Phase 2 study VLA15-221 planned to be initiated in Q1 2021, subject to regulatory approval
  • First clinical study of VLA15 that includes a pediatric population, aged 5-17 years
  • Study will include participants from 5-65 years of age and a reduced immunization schedule (Month 0-6 compared to Month 0-2-6)
  • The study will trigger a milestone payment, upon dosing of the first subject, from Pfizer to Valneva of $10 million
• Phase 3 pivotal efficacy trial is planned to commence in 2022

Saint-Herblain (France), December 2, 2020 – Valneva SE (“Valneva”), a specialty vaccine company focused on prevention of diseases with major unmet needs, today announced its plans to accelerate pediatric development of its Lyme vaccine candidate, VLA15, in collaboration with Pfizer Inc. (NYSE: PFE), with the planned initiation of study VLA15-221 in the first quarter of 2021, subject to regulatory approval.

VLA15-221 is planned as a randomized, observer-blind, placebo-controlled Phase 2 study. Currently, the study will include approximately 600 healthy participants (5-65 years of age) who will receive VLA15 at the dose of 180µg, which was selected based on recent data generated in the two ongoing Phase 2 studies.

If approved, it will be the first clinical study of VLA15 to enroll a pediatric population aged 5-17 years and will compare the three-dose vaccination schedule Month 0-2-6 with a reduced two-dose schedule of Month 0-6.

“This will be an important study that we anticipate will provide evidence that the vaccine can be used in the populations that are at risk of the devastating consequences of Lyme disease, using a simplified schedule,” said Kathrin Jansen, Senior Vice President and Head of Pfizer Vaccine Research and Development.

This study will complement the two ongoing Phase 2 studies VLA15-201 (initial positive data reported on 22^nd July 2020¹) and VLA15-202 (initial positive data reported on 20^th October 2020²). Initial data from study VLA15-221 (primary endpoint) are expected by the second quarter of 2022. VLA15-221 will also investigate a booster dose of VLA15, administered one year following the 6 Month dose. All three Phase 2 trials are anticipated to support a Phase 3 pivotal efficacy trial including all main target populations for the Lyme vaccine candidate starting in 2022.