In This Article:
Shares of Valneva VALN rose 12% on Wednesday after the company announced that it has vaccinated the first participant in a phase II study evaluating its investigational Shigella vaccine, Shigella4V2 (S4V2).
This study will test the safety and immunogenicity of S4V2 in about 110 infants to identify the best vaccine dose for a late-stage study. The study participants will receive a two-dose regimen with either one of two different vaccine dose levels of S4V2 or a control vaccine.
The safety of the vaccine will be closely monitored throughout the study, which will run for six months after the final dose. Results from the study are expected in the second half of 2025.
Shigella is a bacterium that causes shigellosis, the second leading cause of fatal diarrheal disease globally. It significantly contributes to pediatric illness and mortality, especially in low and middle-income countries. Valneva estimates that Shigella is responsible for up to 165 million infections, out of which more than 62 million occur in children younger than five years.
VALN Stock’s Performance
The rise in share price is likely driven by growing investor optimism surrounding the commercial potential of S4V2. With no approved vaccine currently available, shigellosis remains a major global health concern, creating a sizable unmet market opportunity. Adding to the positive sentiment is the FDA’s fast track designation for S4V2 last year, reflecting increased regulatory support and potentially expediting the vaccine’s development and review timeline.
Year to date, shares of Valneva have surged 55% against the industry’s 4% decline.
Image Source: Zacks Investment Research
More on VALN’s Shigella Vaccine
This is the second mid-stage study initiated by Valneva on S4V2. Last year, Valneva started a phase IIb controlled human infection model (CHIM) study, which is evaluating the vaccine in nearly 120 healthy Shigella-naïve participants aged 18 to 50 years.
Both the ongoing mid-stage studies are supported by positive data from a phase I/II study, which showed that S4V2 exhibited a favorable safety and tolerability profile, along with robust immunogenicity against the four most common Shigella serotypes — S. flexneri 2a, 3a, 6 and S. sonnei.
The vaccine is being developed as part of an exclusive licensing agreement with LimmaTech Biologics, signed last year. While LimmaTech remains responsible for conducting both the above-mentioned mid-stage studies, Valneva will be accountable for the vaccine’s further development, regulatory filings and commercialization activities.