Valneva said on Friday it will sent its Lyme disease vaccine candidate VLA15 to clinic. Phase I testing can begin as the FDA cleared Investigational New Drug application (IND) the Clinical Trial Application (CTA) in Belgium showed the green lights.
Valneva pointed out that currently, there is no licensed vaccine against Lyme disease, a multi systemic tick-transmitted infection.
Lyme disease – fastest growing vector-borne infectious disease in U.S.
Each year, an estimated 300,000 Americans and 85,000 Europeans develop Lyme disease and according to the CDC (Centers for Disease Control and Prevention), it is the fastest growing vector-borne infectious disease in the United States.
Valneva’s candidate could be good against Borrelia
Valneva is developing a new hexavalent, protein subunit-based vaccine aimed at the Outer Surface Protein A (OspA) of Borrelia. OspA is, one of the most dominant proteins expressed by the bacteria when present in a tick. Pre-clinical data showed that Valneva`s vaccine candidate can provide protection against the majority of Borrelia species pathogenic for humans.
Thomas Lingelbach, President and CEO, and Franck Grimaud, Deputy CEO of Valneva, said: “We are very pleased to be able to advance our Lyme vaccine candidate which is intended to address such an important unmet medical need. We are committed to finding ways to accelerate the clinical development path to licensure, given that we are conducting the only active vaccine program in the industry.”
Phase I testing at two sites
Valneva`s Phase I trial VLA15-101 is being conducted at two sites – one in the U.S. and one in Belgium. It will enroll 180 patients, aged 18-40 years. The primary objective of the s study will be to evaluate the product candidate`s safety and tolerability. Immunogenicity, measured by observing IgG antibodies specific against six OspA serotypes, will also be monitored for different dose groups and formulations at different time-points.