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Investing.com -- Valneva SE stock rises after the company reported final positive Phase II data for its Lyme disease vaccine candidate VLA15, showing strong immune responses following a third annual booster dose.
The data demonstrated significant anamnestic antibody responses across all six serotypes targeted by the vaccine in children, adolescents, and adults. Following the booster at month 42, antibody levels rapidly increased and remained well above baseline at month 48, supporting the potential for annual protection against Lyme disease.
The three-dose primary series generated significantly higher antibody titers compared to the two-dose regimen. Geometric mean fold rises in antibody titers versus baseline ranged from 9.5-fold for Serotype 1 to 15.6-fold for Serotype 2, with the strongest responses observed in children aged 5-11 years, where responses reached up to 28.5-fold.
Safety profiles remained favorable with no concerns identified by the independent Data Monitoring Committee.
VLA15, being developed in collaboration with Pfizer (NYSE:PFE), is currently the most advanced Lyme disease vaccine in clinical development, with no approved human vaccines available. Two Phase III trials are nearing completion, with regulatory submissions to the FDA and EMA planned for 2026, pending positive data.
"We view the phase III readout expected in H1 2026 as one of the most compelling risk/reward catalysts in the European biotech space over the next six months," noted Stifel analysts.
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