-
Preliminary data from 472 9-month-old infants confirmed a favorable safety and tolerability profile and demonstrated significant immunogenicity against the four most common pathogen serotypes
-
Results support further development, and LimmaTech plans to begin its next clinical trial in 2024
-
Key results of completed Phase I/II are expected to be reported in the first half of 2024
Schlieren, Switzerland, February 22, 2024–(BUSINESS WIRE)—LimmaTech Biologics AG is conducting a Phase I/II evaluation of Shigella4V (S4V), a quadrivalent bioconjugate vaccine candidate against rubella, a bacterial infection. Announced positive interim data from a phase-in clinical trial. Staphylococcus ruber Bacteria. Red wine disease is a serious infectious disease and remains the second leading cause of fatal diarrheal disease, especially in infants in low- and middle-income countries. In a target population of 9-month-olds, administration of S4V demonstrated a favorable safety and tolerability profile, as well as robust data on immunogenicity against the four most common pathogens. Staphylococcus ruber serotype, S. flexneri 2a, 3a, 6, and S. Sonnei. Topline data from the currently completed Phase I/II study in Kenya is expected to be released in the first half of 2024.
LimmaTech's S4V vaccine candidate has demonstrated initial safety in all age groups already evaluated in the first part of clinical trials. The current data update from the second part of the clinical trial includes 472 infants who received her two intramuscular injections at any of four different dose levels, with or without the addition of adjuvant. 9 months ± 1 month). S4V was reported to be well tolerated, with the majority of local and systemic reactions being mild and similarly distributed between different groups. No vaccine-related serious adverse events (SAEs) were reported. Depending on the dose and formulation used, statistically significant increases in serum IgG levels were obtained after the first or second injection.
“These positive interim results for S4V demonstrate that our bioconjugate vaccine candidate can deliver exceptional immunogenicity to 9-month-old infants who need the vaccine most. ” he commented. Dr. Patricia Martin, LimmaTech Chief Operating Officer. “Bacterial bacteriosis is a serious disease caused by pathogens that are constantly evolving and becoming increasingly resistant to antibiotics. Our vaccine candidate will prevent life-threatening infections in many children. It has the potential to protect travelers and military personnel traveling to destinations. Staphylococcus ruber-Fashionable countries. We look forward to continuing clinical development with studies scheduled to begin in 2024. ”
Interim Phase I/II data were previously presented at the BactiVac 4th Annual Network Conference 2023 in Birmingham, UK.
About Phase I/II study
This Phase I/II study conducted in Kenya is a randomized, double-blind, dose-finding, age-depression clinical trial designed to evaluate the safety and immunogenicity of Shigella4V (S4V) . The clinical trial is divided into two parts. Part 1, the age-descending study, evaluated the safety of the vaccine candidate in adults, children (2-5 years), and infants. Part 2, the dose-finding study, will evaluate the safety and immunogenicity of her S4V in a target population of 9-month-olds to identify recommended vaccine doses.
In 2015, LimmaTech entered into a research collaboration agreement with GlaxoSmithKline (GSK) to develop novel bioconjugate antigen-based vaccines containing monovalent antigens. Staphylococcus ruber The vaccine will be developed with support from the Wellcome Trust.Following positive results from monovalent proof-of-concept clinical trials Staphylococcus ruber Vaccines, LimmaTech and GSK begin development of multivalent vaccine Staphylococcus ruber The vaccine is partially funded by a Wellcome Trust grant. In July 2023, LimmaTech announced that it had introduced his S4V license. Staphylococcus ruber GSK's bioconjugate vaccine candidate will lead further development of the program.
About red wine syndrome:
Red wine disease is a global health threat caused by Gram-negative bacteria. Shigella genus Bacteria. It is estimated that approximately 188 million people are infected. Staphylococcus ruber Of these, 62.3 million cases occur in children under 5 years of age. Diarrheal infections are one of the leading causes of morbidity and mortality in many countries, travelers, and military personnel deployed to endemic areas.600,000 people died Staphylococcus ruber It is increasing every year and is now the second leading cause of death due to diarrhea. The standard treatment for bacterial bacteriosis is oral rehydration and antibiotic treatment, but bacteria have acquired resistance to many antibiotics, and many multidrug-resistant strains have been reported, making treatment extremely difficult. is difficult.There are currently no licenses Staphylococcus ruber Vaccines are available.
About Linmatec Biologics
Based on our unparalleled track record in vaccine technology and clinical candidate development, LimmaTech Biologics is at the forefront of combating the global epidemic of antimicrobial resistance. The company leverages its proprietary self-adjuvant and multi-antigen vaccine platform in parallel with additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections. With decades of expertise and a growing and robust pipeline, the LimmaTech team is dedicated to producing protection solutions that deliver innovative value around the world. For more information, please visit www.lmtbio.com.
View source version on businesswire.com. https://www.businesswire.com/news/home/20240222411799/en/
contact address
Linmatec Biologics AG
Franz Werner Haas, CEO
Email: media@lmtbio.com
For media inquiries
Alison Opalko or Alexander Seibert
trophy communications
Phone: +49 1511 0619905
Email: limmatech@trophic.eu