Valneva and LimmaTech Announce First Vaccination in Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine Candidate S4V2

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Saint Herblain (France) and Schlieren (Zurich), November 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participant has been vaccinated in a Phase 2b controlled human infection model (CHIM) study of Shigella4V2 (S4V2), the world’s most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech¹.

In the CHIM study S4V03 (Identifier: NCT06615375), S4V2 will be tested for safety and preliminary efficacy in approximately 120 healthy Shigella-naïve participants aged 18 to 50 years at three sites in the United States. The study, sponsored and conducted by LimmaTech, is a parallel-group, randomized, double-blind, multicenter, placebo-controlled study and will include two steps. In a first step, the vaccine dose will be confirmed and, in a second step, participants will be challenged with the Shigella sonnei strain 53G one month after injection of S4V2 or placebo, in order to assess the ability of S4V2 to protect against the Shigella infection. The infection rate of shigellosis caused by the Shigella sonnei strain 53G in the group vaccinated with S4V2 will then be compared to the group of participants who received placebo injections.

Thomas Lingelbach, Chief Executive Officer of Valneva, commented, "Human challenge studies are unique in their ability to investigate and understand the onset and development of disease in a safe and highly controlled environment. This CHIM study forms part of our staggered and risk-mitigating development strategy for S4V2, as it should provide the first results on efficacy before potentially advancing to further CHIM and Phase 3 studies.”

Dr. Patricia Martin, Chief Operating Officer of LimmaTech, stated, "The start of this trial is a significant milestone for the S4V2 program and our combined efforts with Valneva to bring an effective vaccine against shigellosis to market. Today, we are an important step closer to LimmaTech’s vision of developing vaccines to fight against serious diseases and antimicrobial resistant pathogens.”

In addition to the CHIM study, LimmaTech will conduct a Phase 2 pediatric study in Low- and Middle-Income Countries expected to begin before the end of 2024. Valneva will assume all further development, including CMC (chemistry, manufacturing and controls) and regulatory activities, and be responsible for its commercialization worldwide, if approved.
Last month, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to S4V2, recognizing its potential to address a serious condition and fill an unmet medical need².

Shigellosis is the second leading cause of fatal diarrheal disease worldwide. However, there is currently no approved Shigella vaccine and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO)³.

About Shigellosis
Shigellosis is a global health threat caused by the Gram-negative Shigella bacteria. It is estimated that up to 165 million infections⁴ are due to Shigella of which 62.3 million occur in children younger than five years. Diarrheal infection is one of the major causes of morbidity and mortality in numerous countries as well as in travelers and deployed military personnel in endemic regions. There are an estimated 600,000 deaths attributed to Shigella each year and it is the second leading cause for diarrheal deaths⁵. The standard treatment for shigellosis is oral rehydration and antibiotic therapy, however, the bacteria have acquired resistance to many antibiotics with numerous reports of outbreaks of multidrug-resistant strains, making treatment extremely difficult. Currently, no licensed Shigella vaccine is available.

About Valneva SE

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.
We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines.
Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com.

About LimmaTech Biologics AG
LimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections. With decades of expertise and an expanding, robust pipeline, the LimmaTech team is dedicated to generating protective solutions to deliver transformative value worldwide. LimmaTech Biologics is backed by specialist healthcare investors, including Adjuvant Capital, AXA IM Alts, Novo Holdings REPAIR Impact Fund, and Tenmile.
For more information, please visit www.lmtbio.com.

For LimmaTech
LimmaTech Biologics AG
Franz-Werner Haas, CEO
E-mail: media@lmtbio.com

For media enquiries
Trophic Communications
Gretchen Schweitzer or Jacob Verghese
Phone: +49 172 861 8540
E-mail: limmatech@trophic.eu

Forward-Looking Statements

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to financial results for 2024; mid-term revenue and cash outlook; the progress, timing, results and completion of research, development and clinical trials for product candidates; regulatory approval of product candidates and requested label extensions; and review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as "could,” "should,” "may,” "expects,” "anticipates,” "believes,” "intends,” "estimates,” "aims,” "targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

1 LimmaTech Biologics AG
2 Valneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V - Valneva
3 Immunization, Vaccines and Biologicals (who.int)
4Shigellosis | CDC Yellow Book 2024
5 Shigellosis | CDC Yellow Book 2024

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