Valneva, Pfizer hasten pediatric development of Lyme vaccine candidate

Valneva SE, a biotech company headquartered in France, on Wednesday announced plans to accelerate the pediatric development of its Lyme disease vaccine candidate, VLA15, which is being co-developed with Pfizer Inc.

“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,” Dr. Juan Carlos Jaramillo, Valneva’s chief medical officer, said in a written statement. 

Valneva is developing and commercializing other vaccines for infectious diseases with major unmet needs, including those against COVID-19 and chikungunya. 

If approved by regulators, the planned clinical study of VLA15 scheduled for the first quarter of 2021 — known as VLA15-221 — would be the first to enroll a pediatric population aged 5-17 years and will compare the three-dose vaccination schedule with a reduced two-dose schedule, according to Valneva. VLA15 is the only active Lyme disease vaccine in clinical development today. 

“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,” Jaramillo said. 

The clinical study is planned as a randomized, observer-blind, placebo-controlled Phase 2 study that will include roughly 600 healthy participants ages 5-65 years.

“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.

Lyme, an infectious disease caused by a bacteria that is transmitted to humans from infected ticks, is the most common vector-borne illness in the Northern Hemisphere. The U.S. Centers for Disease Control and Prevention (CDC) states that approximately 300,000 Americans are diagnosed with Lyme each year. 

The clinical study also will complement the two ongoing Phase 2 studies, VLA15-201 and VLA15-202, which both have shown initial positive data reported this year, according to Valneva, which said that all three Phase 2 trials are expected to support a Phase 3 pivotal efficacy trial, including all main target populations for the Lyme vaccine candidate starting in 2022.

Valneva and Pfizer in April entered into an agreement to co-develop and commercialize VLA15. Under terms of the agreement, the first subject, first dose in the study will trigger a $10 million payment from Pfizer to Valneva, thereby allowing for faster pediatric development of the Lyme vaccine candidate.

Valneva is eligible to receive from Pfizer a total of $308 million in cash payments, which included a $130 million upfront payment, as well as $35 million in development milestones and $143 million in early commercialization milestones. Valneva will fund 30 percent of all development costs through completion of the development program, and in return Pfizer will pay Valneva tiered royalties starting at 19 percent, according to their agreement, which makes Pfizer the lead in late-stage development and the company having sole control over commercialization.