GSK4069327A / GSK, LimmaTech Biologics, Valneva - LARVOL DELTA

Valneva Reports Preliminary Unaudited 2024 Revenue and Cash and Provides 2025 Outlook (GlobeNewswire) - "Met 2024 growth targets for sales revenue (+13% vs 2023) and total revenues (+10% vs 2023); Key Upcoming Catalysts...Lyme disease Phase 3 first data readout by the end of 2025; Further chikungunya vaccine approvals, including the first endemic country (Brazil) and adolescent label extensions for IXCHIQ in major travel markets; Initiation of Phase 3 pediatric trial of IXCHIQ to support further potential label expansion; Phase 2b efficacy data from Human Challenge Study (CHIM) of tetravalent Shigella vaccine candidate in mid-2025 and launch of pediatric study; Phase 1 results for Zika vaccine candidate in the first half of 2025"

Commercial • New trial • P1 data • P3 data • Chikungunya • Infectious Disease • Lyme Disease

A Shigella flexneri 2a Vaccine Applying the Generalized Modules for Membrane Antigens (GMMA) on a Microneedle Induces Humoral Immune Responses in Mice (ASM Microbe 2024) - "Still, similar efficacy with pMN and IM was obtained from the concentration of 1 μg/dose after prime and boost immunization. Thus, administering S. flexneri 2a GMMA with a microneedle can be a promising approach for developing an S. flexneri 2a vaccine that can be easily distributed to developing countries."

Preclinical • Infectious Disease

A Shigella flexneri 2a Vaccine Applying the Generalized Modules for Membrane Antigens (GMMA) on a Microneedle Induces Humoral Immune Responses in Mice (ASM Microbe 2024) - "Still, similar efficacy with pMN and IM was obtained from the concentration of 1 μg/dose after prime and boost immunization. Thus, administering S. flexneri 2a GMMA with a microneedle can be a promising approach for developing an S. flexneri 2a vaccine that can be easily distributed to developing countries."

Preclinical • Infectious Disease

A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants (clinicaltrials.gov) - P1/2 | N=596 | Completed | Sponsor: LimmaTech Biologics AG | Active, not recruiting ➔ Completed | Trial completion date: May 2023 ➔ Nov 2022

Trial completion • Trial completion date

A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants (clinicaltrials.gov) - P1/2 | N=592 | Active, not recruiting | Sponsor: LimmaTech Biologics AG | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2022 ➔ May 2023 | Trial primary completion date: Jul 2022 ➔ Oct 2022

Enrollment closed • Trial completion date • Trial primary completion date

Immunization of Rabbits with a Quadrivalent Shigella Bioconjugate Vaccine Induces Functional Antibodies Reactive with Shigella Isolates from Kenya. (PubMed, mSphere) - "This study demonstrates the breadth of reactivity and functionality of the parenterally administered bioconjugate vaccine by evaluating the ability of rabbit sera to bind and kill Shigella isolates recently collected in Kenya. These results suggest that the Shigella quadrivalent vaccine may be more broadly protective than designed and may offer a promising solution to the morbidity and mortality associated with Shigella infections."

Journal • Preclinical • Infectious Disease

Shigella-Specific Immune Profiles Induced after Parenteral Immunization or Oral Challenge with Either Shigella flexneri 2a or Shigella sonnei. (PubMed, mSphere) - "Analyses conducted here provide essential insights into the potential of different immune mechanisms required to elicit protective immunity, depending on the Shigella serotype. Such differences could have significant impacts on vaccine design and development within the Shigella field and should be further investigated across multiple Shigella serotypes."

Journal • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease