Valneva Reports Positive Phase I Interim Results for Its Lyme Vaccine Candidate VLA15
Phase I study (VLA15-101) primary endpoint met
- No safety concerns associated with VLA15 in any treatment group
Encouraging immunogenicity with VLA15
- VLA15 is immunogenic in all doses and formulations tested
- Good OspA-specific IgG antibody responses against all OspA serotypes
Lyon (France), March 19, 2018 - Valneva SE ("Valneva" or "the Company"), a fully integrated, commercial stage biotech company focused on developing innovative lifesaving vaccines, today announced positive Phase I interim results for its Lyme vaccine candidate, VLA15.
The primary objective of the Phase I study VLA15-101 was to evaluate the vaccine candidate's safety and tolerability profile at different dose levels and formulations. Immunogenicity, measured by determining IgG antibodies against the six most prevalent serotypes of Lyme borreliosis in the US (ST1) and Europe (ST1 to ST6) present in the vaccine, was also monitored for different dose groups and formulations at various time-points.
This interim analysis for the primary and secondary endpoints includes safety and immunogenicity data up to Day 84 (month 3).
The study met its primary endpoint: the vaccine candidate showed a favourable safety profile. There were very few severe, related AEs in all treatment groups and no associated safety concerns.
No differences in the safety profile were observed for the adjuvanted groups compared to the non-adjuvanted treatment groups.
The safety profile of all tested doses and formulations is considered comparable to other licensed lipidated recombinant vaccines or lipid-containing vaccine formulations, and supports further clinical development for all doses and formulations.
VLA15 was also immunogenic in all doses and formulations tested. OspA-specific IgG antibody responses were induced in all treatment groups and against all OspA serotypes, with significant dose responses seen between the lowest and the highest dose groups. VLA15 was more immunogenic in adjuvanted treatment groups compared to non-adjuvanted treatment mMthe same dose level. For all six OspA serotypes, IgG levels were substantially higher after three immunizations (Day 84) compared to after two (Day 56).
Seroconversion Rates (SCR) for the highest, adjuvanted dose group, which is considered preferred for further development, ranged from 71.4% to 96.4% for the different OspA serotypes.
Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva commented "We are extremely pleased to report a successful first human trial for our vaccine candidate against Lyme disease, a severe infection which affects an increasing number of people each year. We look forward to providing access to an effective prevention against a disease that is too often underdiagnosed, leaving many infected people with no or inadequate treatment and resulting in a heavy public health and economic burden".
The Company is committed to advance its Lyme vaccine candidate as quickly as possible into Phase II, further to requisite dialogue with the Authorities. Phase II is currently expected to commence in the second half of 2018.
The next clinical phase is intended to be conducted in Lyme-endemic regions and will include people previously infected with Borrelia burgdorferi, the bacteria that cause Lyme disease. Further dose optimization will be considered.
About The Phase I Clinical Study VLA15-101
This study is a first-in-human observer-blind, partially randomized, dose escalation Phase I study that aims to evaluate the safety, tolerability and immunogenicity of Valneva's vaccine candidate VLA15. The study enrolled 179 healthy adults under 40 years of age in Europe and the U.S. who were not previously infected with Borrelia burgdorferi. Subjects were randomized into six treatment groups to receive one of three dose levels either in an alum adjuvanted formulation or without adjuvant. Study subjects were vaccinated at three occasions one month apart (Day 0-28-56). The interim analysis for the primary and secondary endpoints included safety and immunogenicity data up to Day 84 (Month 3). Final safety and immunogenicity data including one year follow-up are expected early 2019.
Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT03010228.
About Lyme disease
Lyme disease is a systemic infection caused by Borrelia bacteria transmitted to humans by infected Ixodes ticks. It is considered the most common vector borne illness in the Nothern Hemisphere. According to the Centers for Disease Control and Prevention (CDC), approximately 400,000 Americans are diagnosed with Lyme disease each year with at least a further 200,000 cases in Europe. Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called Erythema migrans or more unspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia or myalgia) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious complications affecting the joints (arthritis), the heart (carditis) or the nervous system.
The medical need for vaccination against Lyme disease is steadily increasing as the disease footprint widens.
Valneva's vaccine candidate, VLA15, is currently the only active vaccine program in clinical development against Lyme disease. The program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 2017.
VLA15 is a multivalent, protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia. It is designed for prophylactic, active immunization against Lyme disease in individuals above 2 years of age) aiming for protection against the majority of human pathogenic Borrelia species. VLA15 is designed to confer protection by raising antibodies that prevent Borrelia from migrating from ticks to humans after a bite. The anticipated safety profile is expected to be similar to other vaccines using the same technology that have been approved for active immunization in adults and children.
The target population includes individuals at risk living in endemic areas, people planning to travel to endemic areas to pursue outdoor activities and people at risk who have a history of Lyme disease (as infection with Borrelia does not confer protective immunity against all pathogenic Borrelia species).
Vaccination with OspA was already proven to work in the 1990s and VLA15 pre-clinical data showed that the vaccine has the potential to provide protection against the majority of the Borrelia species pathogenic for humans.
The global market for a vaccine against Lyme disease is currently estimated at approximately €700 - €800 million annually.
About Valneva SE
Valneva is a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines.
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 a unique vaccine against Lyme disease.
Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 450 employees. More information is available at www.valneva.com.
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 Stanek et al. 2012, The Lancet 379:461-473
 As estimated by the CDC based on reported cases in 2015
 Estimated from available national data. Number largely underestimated based on WHO Europe Lyme Report as case reporting is
highly inconsistent in Europe and many LB infections go undiagnosed; ECDC tick-borne-diseases-meeting-report
New Scientist, Lyme disease is set to explode and we still don't have a vaccine; March 29, 2017