LimmaTech Biologics AG

Valneva and LimmaTech Advance Pioneering Shigella Vaccine into Phase 2 Trials

a month ago

• Valneva and LimmaTech have initiated two Phase 2 clinical trials for S4V2, the world's most clinically advanced tetravalent bioconjugate vaccine candidate against shigellosis, a major global health threat. • Shigellosis causes approximately 165 million infections annually, resulting in 600,000 deaths worldwide, with children under five in low- and middle-income countries being particularly vulnerable. • The FDA has granted Fast Track designation to S4V2, recognizing its potential to address a serious condition with no currently approved vaccine, despite increasing antibiotic resistance complicating treatment.

Inventiva Restructures to Focus on MASH Drug Development, Reports €96.6M Year-End Cash Position

3 months ago

• Inventiva announces strategic pipeline prioritization, halting all preclinical research to focus exclusively on lanifibranor development for MASH treatment, with planned 50% workforce reduction. • Company reports €96.6 million cash position at 2024 year-end, securing operations until Q3 2025, with potential additional funding of €116 million expected in Q2 2025. • Last patient screening completed in NATiV3 Phase 3 trial of lanifibranor, with final patient randomization expected in first half of 2025 and topline results anticipated in second half of 2026.

Los Angeles Shigellosis Outbreak Caused by Mutation

5 months ago

A mutation in the Shigella sonnei bacteria has led to an extensively drug-resistant (XDR) Shigellosis outbreak in Los Angeles, with California reporting 4,365 of the 20,621 cases nationwide in 2024. The mutation makes the bacteria resistant to cephalosporins, a class of antibiotics, highlighting the urgent need for improved detection and management strategies.

FDA Grants Fast Track Status to LimmaTech's Staphylococcus aureus Vaccine

5 months ago

• LimmaTech Biologics' LBT-SA7 vaccine candidate receives FDA Fast Track designation to prevent Staphylococcus aureus skin and soft-tissue infections. • The multivalent toxoid vaccine addresses the urgent need for new treatments due to increasing antibiotic resistance and the lack of available vaccines. • A Phase 1 clinical trial involving 130 participants aged 18-50 is planned, with initial results expected in the second half of 2025. • The FDA's decision highlights its commitment to addressing serious health threats and facilitating the development of innovative medical solutions.

FDA Grants Fast Track Designation to LimmaTech's Staphylococcus aureus Vaccine Candidate

5 months ago

• LimmaTech's LBT-SA7, a multivalent toxoid vaccine, receives FDA Fast Track designation for preventing Staphylococcus aureus skin and soft tissue infections (SSTIs). • The FDA's decision aims to expedite LBT-SA7's development, allowing more frequent engagement with LimmaTech to address the unmet need for an S. aureus vaccine. • LBT-SA7 targets the toxins secreted by S. aureus, offering a novel approach to prevent SSTIs, which account for 90% of community-acquired S. aureus infections. • A Phase 1 clinical trial is planned to assess the safety and immunogenicity of LBT-SA7 in healthy volunteers, with initial results expected in the second half of 2025.

Valneva and LimmaTech Receive FDA Fast Track Designation for Shigella Vaccine Candidate

7 months ago

• Valneva and LimmaTech's Shigella4V (S4V), a tetravalent bioconjugate vaccine candidate, has received FDA Fast Track designation, aimed at expediting the development of treatments for serious conditions. • Shigellosis, caused by Shigella bacteria, affects up to 165 million people annually, resulting in approximately 600,000 deaths, particularly impacting children in low- and middle-income countries. • LimmaTech will conduct Phase 2 trials, and Valneva will handle further development, CMC, regulatory activities, and commercialization, with plans to leverage CHIM studies for initial adult approval. • The Fast Track designation will facilitate closer collaboration with the FDA to accelerate the delivery of a preventative solution against Shigella, addressing a critical unmet medical need.

LimmaTech's Staphylococcus aureus Vaccine Candidate, LBT-SA7, Receives FDA Fast Track Designation

3 years ago

• LimmaTech's LBT-SA7, a multivalent toxoid vaccine, has been granted FDA Fast Track designation to prevent Staphylococcus aureus skin and soft tissue infections (SSTIs). • The Fast Track designation will expedite LBT-SA7's development by allowing more frequent engagement with the FDA regarding its clinical development plan. • LBT-SA7 is designed to neutralize toxins secreted by S. aureus, offering a novel approach to combatting infections amid rising antibiotic resistance. • A Phase 1 clinical trial, involving 130 participants, will assess the safety and immunogenicity of LBT-SA7, with initial results expected in the second half of 2025.