Lyme Disease Vaccine Candidate Secures Pfizer Investment

France-based Valneva SE and Pfizer Inc. today announced that they have entered into new agreements for the Lyme disease vaccine candidate VLA15. As part of the Equity Subscription Agreement, Pfizer will invest €90.5 ($95) million in Valneva, which is planning to use the proceeds to support its Phase 3 development contribution to the Lyme disease program.

In addition, Valneva and Pfizer updated the terms of their VLA15 collaboration and license agreement which they announced on April 30, 2020.

As announced on April 26, 2022, Pfizer plans to initiate the Phase 3 study of VLA15 in the third quarter of 2022.

Pending successful initiation and completion of the planned Phase 3 study for VLA15, Pfizer could potentially submit a Biologics License Application to the U.S. FDA as early as 2025.

As of June 20, 2022, VLA15 is the only Lyme disease vaccine candidate in clinical development.

Valneva and Pfizer entered an initial collaboration agreement to co-develop VLA15 in April 2020.

 "Lyme disease continues to place a heavy burden on countries in North America and Europe, with an estimated 600,000 cases each year across both regions," said Kathrin U. Jansen, Ph.D., SVP and Head of Vaccine Research & Development at Pfizer, in a press release issued on June 20, 2022.

"As the geographic footprint of Lyme disease widens, the medical need for vaccination becomes even more imperative."

"We are excited to continue partnering with Valneva on the development of VLA15 and look forward to working together to progress the program to bring forward a vaccine that could help prevent this debilitating disease."

This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease.

OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick.

Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by infected Ixodes ticks.

It is considered the most common vector-borne illness in the Northern Hemisphere.

According to a study published on June 13, 2022, in BMJ Global Health, Lyme disease has likely infected 14.5% of the world's population.

Note: This Valneva announcement was manually curated for mobile readership.