Valneva Announces Acceleration of Pediatric Development for Lyme Disease Vaccine Candidate - Seite 2

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva commented “We believe that including the pediatric population early on could provide support for the Phase 3 study to include all major target groups for our future Lyme vaccine candidate and may potentially support successful market access including respective recommendations. We are pleased that Pfizer and Valneva have decided to accelerate this development step while preparing for a potential Phase 3 start, expected in 2022.”

Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop and commercialize VLA15.

Under the terms of the agreement, first subject, first dose in this study will trigger a milestone payment of $10 million from Pfizer to Valneva. The original Valneva plan, prior to the Pfizer agreement, assumed age de-escalation post-licensure. The Pfizer collaboration allows acceleration of pediatric development.

About VLA15
VLA15 is the only active Lyme disease vaccine in clinical development today, and covers six serotypes that are prevalent in North America and Europe. This investigational multivalent protein subunit vaccine 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 promising immunogenicity and safety data in pre-clinical and clinical studies so far. The program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 2017³.
Valneva and Pfizer announced a collaboration for VLA15’s development and commercialization at the end of April 2020⁴. The two companies are working closely together on the next development steps.

About Clinical Study VLA15-221
VLA15-221 is a randomized, observer-blind, placebo controlled Phase 2 study. It is the first clinical study with VLA15 that will enroll a pediatric population aged 5 years and older.
A total of approximately 600 participants will receive VLA15 at two different immunization schedules (Month 0-2-6 or Month 0-6, 200 volunteers each) or placebo (Month 0-2-6, 200 volunteers). The main safety and immunogenicity readout (Primary Endpoint analysis) is anticipated at Month 7, where peak antibody titers are expected. A subset of participants will receive a booster dose of VLA15 or placebo at Month 18 (Booster Phase) and will be followed for three further years to monitor the antibody persistence.