Staphylococcus aureus toxoid multivalent vaccine (Integrated BioTherapeutics) Advanced Drug Monograph

Staphylococcus aureus Toxoid Multivalent Vaccine (Integrated BioTherapeutics) Report

Name: Staphylococcus aureus toxoid multivalent vaccine (Integrated BioTherapeutics) Name (English): Staphylococcus aureus toxoid multivalent vaccine (Integrated BioTherapeutics) Developer: Integrated BioTherapeutics, Inc. (IBT) Vaccine Candidate Designation: IBT-V02 Target Pathogen: Staphylococcus aureus (including Methicillin-resistant Staphylococcus aureus - MRSA) Type: Multicomponent toxoid vaccine Antigens: Targets multiple S. aureus toxins, including: * Alpha hemolysin (Hla) * Panton-Valentine leukocidin (PVL) * Leukocidin AB (LukAB) * Toxic shock syndrome toxin-1 (TSST-1) * Staphylococcal enterotoxin A (SEA) * Staphylococcal enterotoxin B (SEB) Mechanism of Action: Induces broadly neutralizing antibodies against key S. aureus toxins, aiming to prevent the complications of invasive disease and skin infections rather than achieving sterile immunity. The toxoids are mutated to be non-toxic but retain immunogenicity. Development Stage: Late pre-clinical development. Pre-clinical Efficacy: Demonstrated efficacy in animal models (mice and rabbits) against primary and secondary skin infections caused by various clinically relevant S. aureus strains, including USA100, USA300, and MRSA. Showed lasting efficacy against secondary infections and protection even in non-naïve animals. Formulations: Developed in liquid, lyophilized (freeze-dried), and spray freeze-dried formulations, with solid formulations showing comparable stability to the liquid form, even at room temperature, which is beneficial for regions lacking reliable cold storage. Funding/Partnerships: Received funding from the NIH, CARB-X, and Novo Holdings REPAIR Impact Fund to support development. Clinical Trials: A Phase 1 clinical trial in the United States involving 130 participants aged 18 to 50 years is planned, with initial results expected in the second half of 2025. Regulatory Status: Granted Fast Track designation by the US Food and Drug Administration (FDA) to expedite the review process. Goal: To develop a novel vaccine to prevent S. aureus infections, particularly skin and soft-tissue infections (SSTIs), and to address the increasing threat of antibiotic resistance. SSTIs constitute a large majority of S. aureus infections and can lead to more severe invasive diseases. Significance: Aims to be a first-in-market multivalent toxoid vaccine with broad coverage against S. aureus toxins, addressing a significant unmet medical need as no S. aureus vaccine is currently available for human use.