Valneva Receives FDA and European Approvals to Start Clinical Testing of Lyme Disease Vaccine Candidate

Valneva SE (“Valneva” or “the Company”), a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines, today announced that its vaccine candidate VLA15 against Lyme disease is now progressing into clinical testing (Phase I) following the Investigational New Drug application (IND) clearance from the Food & Drug Administration (FDA) and the approval of the Clinical Trial Application (CTA) in Europe (Belgium).

Currently, there is no licensed vaccine available to protect humans against Lyme disease, a multi systemic tick-transmitted infection that can cause serious health problems and disabilities. 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 is developing a new hexavalent, protein subunit-based vaccine targeting 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 (1).

Thomas Lingelbach, President and CEO, and Franck Grimaud, Deputy CEO of Valneva, commented, “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.”
Valneva´s Phase I trial VLA15-101 is being conducted at two sites – one in the U.S. and one in Europe (Belgium) and will enroll 180 subjects, aged 18-40 years. The primary objective of the single-blind, partially randomized, dose escalation 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.

Investor Meeting and Live Webcast in New York, December 12th, 12pm Eastern Time
Considering the strong interest shown on the disease by investors, shareholders and the general public, Valneva is hosting a conference on Lyme disease in New York on December 12, 2016 to provide more detailed information on the disease and the opportunity to develop a vaccine. The conference will be co-presented by Prof. Stanley A. Plotkin, Emeritus Professor, University of Pennsylvania, and Valneva’s Lyme R&D experts led by CEO Thomas Lingelbach. To register for the conference, please visit Valneva’s website
(http://www.valneva.com/en/)

(1) journals.plos.org/plosone/article



About Valneva SE
Valneva is a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines.
The Company seeks financial returns through focused R&D investments in promising product candidates and growing financial contributions from commercial products, striving towards financial self-sustainability.
Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT®indicated for the prevention of Japanese encephalitis and DUKORAL®indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has proprietary vaccines in development including candidates against Clostridium difficile and Lyme Borreliosis. A variety of partnerships with leading pharmaceutical companies complement the Company’s value proposition and include vaccines being developed using Valneva’s innovative and validated technology platforms (EB66®vaccine production cell line, IC31®adjuvant).
Valneva is listed on Euronext-Paris and the Vienna stock exchange and has operations in France, Austria, Great Britain, Sweden, Canada and the US with over 400 employees. More information is available at www.valneva.com.

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