Valneva SE (NASDAQ:VALN) shared final immunogenicity and safety data on Wednesday from the Phase 2 study, VLA15-221, of the Lyme disease vaccine candidate, VLA15.
Lyme disease is a bacterial infection transmitted to humans by infected ticks, often presenting with an early “bull’s-eye” rash and flu-like symptoms such as fever, headache, and fatigue.
The results showed a strong anamnestic immune response and a favorable safety profile six months after a third booster dose (month 48) in all age groups, confirming compatibility with the anticipated benefits of a yearly vaccination before each Lyme season.
Pfizer Inc. (NYSE:PFE) and Valneva entered into a collaboration agreement in April 2020 for Pfizer to develop and commercialize VLA15.
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The Centers for Disease Control and Prevention (CDC) estimates that approximately 476,000 people in the U.S. are diagnosed and treated for Lyme disease each year, and 132,000 cases are reported annually in Europe.
Subject to positive Phase 3 data, Pfizer aims to submit a Biologics License Application to the U.S. Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency in 2026.
As observed in previous VLA15 clinical studies, an additional dose immediately boosted antibody levels, which then gradually declined over time but remained well above baseline in all study groups, confirming their persistence at month 48, six months after vaccination at month 42.
The study compared two dosing schedules, and overall, antibody levels remained higher with the three-dose primary vaccination schedule compared to the two-dose schedule.
Geometric mean fold rise (GMFRs) compared to baseline ranged from 9.5-fold for Serotype 1 (ST1) to 15.6-fold for Serotype 2 (ST2) across all age groups in the three-dose Month 0-2-6 primary vaccination schedule.
The highest GMFRs were reported in the 5 to 11-year-old age group, with GMFR levels ranging from 15.5-fold (ST1) to 28.5-fold (ST2).
These results further validate the use of the three-dose vaccination schedule and a yearly booster dose, already included in the Phase 3 protocols.
The safety and tolerability profile of VLA15 six months after the third booster dose was similar to the profile observed after previous booster doses.
On Wednesday, Valneva also announced a strategic initiative to optimize its organizational footprint in France to improve operational effectiveness and position the company for long-term success.
The company plans to concentrate its French operations at its Lyon location, closing the site in Nantes, which currently includes operational as well as certain pre-clinical R&D activities.
VALN Price Action: Valneva shares were up 7.65% at $9.19 at the time of publication on Wednesday, according to Benzinga Pro data.
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