Valneva Shares Climb on Positive Lyme Disease Vaccine Booster Data
Biotech firm and partner Pfizer report strong immune response in Phase 2 trial, bolstering prospects for the first human vaccine against the tick-borne illness in two decades.
Shares of French biotechnology company Valneva SE (NASDAQ: VALN) advanced on Tuesday after the company and its development partner, Pfizer, announced positive final data from a Phase 2 study of their Lyme disease vaccine candidate, VLA15.
The results showed that a booster dose of VLA15 elicited a strong immune response in both adults and children, reinforcing antibody levels six months after the initial vaccination course. This outcome supports the potential for an annual booster schedule, a critical feature for a vaccine targeting a seasonal pathogen, and moves the candidate one step closer to becoming the first approved human vaccine for Lyme disease in the U.S. in over 20 years.
In morning trading, Valneva's American Depositary Receipts rose, reflecting investor optimism for the vaccine program, which represents a significant commercial opportunity. The company, which has a market capitalization of approximately $764 million, is developing VLA15 in a collaboration that leverages Pfizer's vast clinical development and commercialization capabilities.
The Phase 2 study, VLA15-221, demonstrated that antibody levels remained significantly above baseline across all six targeted serotypes of the Borrelia burgdorferi bacterium prevalent in North America and Europe. According to the company's official press release, the vaccine candidate maintained a favorable safety profile, with no safety concerns identified by the independent Data Monitoring Committee.
Lyme disease is the most common vector-borne illness in the United States, with the Centers for Disease Control and Prevention estimating that nearly half a million people are diagnosed and treated for it each year. The disease can cause debilitating long-term symptoms, including arthritis, neurological, and cardiac issues, creating a significant public health burden and a substantial market for a preventative vaccine.
The collaboration between Valneva and Pfizer, initiated in April 2020, has been structured to accelerate VLA15 through late-stage trials. Under the terms of the agreement, Pfizer invested €90.5 million ($95 million) in Valneva in 2022 and is leading the ongoing Phase 3 "Vaccine Against Lyme for Outdoor Recreationists" (VALOR) trial. Valneva is funding 40% of the remaining shared development costs and is eligible for tiered royalties ranging from 14% to 22%, in addition to potential milestone payments.
Analysts are closely watching the progress of the Phase 3 study, viewing its completion as a pivotal catalyst for Valneva. As reported by MarketWatch, the positive Phase 2 booster data adds to a growing body of evidence supporting the vaccine's viability. The consensus analyst target price for VALN stock sits at $11.62, suggesting further upside potential if the vaccine continues to meet its clinical endpoints.
With the VALOR trial's primary vaccination series now complete for participants, the focus shifts to monitoring for incidents of Lyme disease through the end of the 2025 season. Subject to positive Phase 3 data, Pfizer intends to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2026.
The successful development of VLA15 would not only provide a critical tool in the fight against Lyme disease but also validate Valneva's specialized vaccine development platform. For Pfizer, it would add a novel vaccine to its portfolio, addressing a clear and persistent unmet medical need.