Positive Phase I/II Results for LimmaTech's Shigella4V Tetravalent Vaccine

Early findings from a study involving 472 infants aged nine months show that a new vaccine candidate, Shigella4V (S4V), developed by LimmaTech, has a good safety record and is well tolerated. The vaccine is designed to protect against shigellosis, a severe infection that is particularly dangerous for infants in lower-income countries and is the second most common cause of fatal diarrheal disease. The trial, which took place in Kenya, found that S4V effectively stimulated an immune response against the four most prevalent serotypes of Shigella bacteria.
The company plans to start the next phase of clinical trials in 2024, with the topline results from the completed Phase I/II trial expected to be announced in the first half of the same year. The vaccine candidate has already proven safe for all age groups in the initial part of the trial. The second part, which focused on infants, involved two intramuscular injections at varying doses, either with or without an adjuvant. The vaccine was well-tolerated, with most reactions being mild and evenly distributed across groups. Importantly, no serious adverse events linked to the vaccine were reported, and there was a significant increase in serum IgG levels following one or both injections.
Patricia Martin, LimmaTech's COO, highlighted the vaccine's potential to prevent a disease that poses a significant threat to children's lives and to safeguard travelers and military personnel in Shigella-endemic regions. The interim data from the Phase I/II study were presented at the BactiVac 4th Annual Network Meeting in 2023 in the UK.
The Phase I/II study was a randomized, double-blind, dose-ranging clinical trial aimed at assessing the safety and immunogenicity of S4V. It was divided into two parts: the first evaluated the vaccine's safety in adults and children, while the second focused on identifying the optimal vaccine dose for the nine-month-old target group.
LimmaTech has been collaborating with GlaxoSmithKline (GSK) since 2015 to develop novel bioconjugate antigen-based vaccines, including a monovalent Shigella vaccine. Following successful proof-of-concept trials, LimmaTech and GSK began developing a multivalent Shigella vaccine, partially funded by the Wellcome Trust. In July 2023, LimmaTech acquired the rights to the S4V candidate from GSK to lead the program's further development.
Shigellosis, caused by Shigella bacteria, is a significant global health issue, with an estimated 188 million infections annually, affecting over 62 million children under five. The disease is a leading cause of morbidity and mortality in many countries and poses a risk to travelers and military personnel in endemic areas. Despite the availability of oral rehydration and antibiotics as treatments, resistance to these therapies is increasing, complicating treatment efforts. Currently, no Shigella vaccine is licensed for use.
LimmaTech Biologics is a leader in the fight against antimicrobial resistance, leveraging its expertise in vaccine technology and clinical candidate development to combat untreatable infections. The company's self-adjuvanting and multi-antigen vaccine platform, along with its disease-specific approaches, are aimed at preventing infections that are becoming increasingly difficult to treat. With a strong pipeline and a dedicated team, LimmaTech is committed to creating protective solutions that deliver significant global value.

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