Exbaq LLC

Multivalent Adjuvant Immunization to Prevent Hospital Acquired Infections - Project Summary/abstract Two Million Healthcare Associated Infections (HAIS) Occur Per Year in the Us, Killing >90,000 Patients and Costing ~$50-100 Billion (adjusted by Cpi to 2020 Dollars). Hais Are the 6TH Leading Cause of Death in the Us, Ahead of Diabetes and Kidney Disease. Reducing Hais Is a Top Priority of the Us Department of Health and Human SERVICES1 and Experts Have Called for Novel Strategies Including Vaccination to Achieve This GOAL.2 Exbaq Is a Biotechnology Company Founded by a Consortium of Scientists and Business Colleagues Who Have Spent Years Studying Antibiotic-resistant Nosocomial Pathogens. Exbaq Is Developing a Vaccine to Prevent Hais Comprised of Innate-immune Stimulatory Molecules That Provide Broad-spectrum Protection Against Infection Caused by Cross-kingdom Hai Pathogens (preliminary Data). Our Vaccine Consists of: a) Aluminum Hydroxide (AL(OH)3), Which Is Contained in Multiple Fda-approved Vaccines, and Enhances Immunity via Multiple Mechanisms, Including Induction of Depot Formation, Activating the NALP3 Inflammasome, and Enhancing Particulate Uptake by Macrophages; B) Monophosphoryl Lipid a (MPL), Which Is Also Contained (in Combination With AL(OH)3) in Multiple Fda-approved Vaccines and Activates the NF-B Pathway via TLR4 Ligation; C) Mannan, Which Stimulates a Variety of Innate and Adaptive Immune Pathways, and Was Safe in Clinical Trials When Administered Parenterally. During Phase I We Have Confirmed That This Triple Adjuvant Regimen Has the Broadest Protection Against Pathogens, Affording Lower Doses (important for Cost of Goods), Compared to a Triple Regimen Containing Whole Glucan Particles Instead of Mannan, or With a Quadruple Regimen (preliminary Data). Efficacy of the Triple Regimen Has Been Confirmed in Lethal Mouse Models of Carbapenem-resistant Acinetobacter Baumannii and Klebsiella Pneumoniae, Methicillin-resistant Staphylococcus Aureus (mrsa), and Disseminated Infection Caused by the Fungi Candida Albicans and Rhizopus Delamar (mucormycosis). Given Efficacy Against Gram- Positive and -negative Bacteria and Fungal Pathogens, Our Trivalent Vaccine Has Potential to Prevent Hais Caused by the Highest Priority, Antibiotic-resistant Nosocomial Pathogens. Having Established an Optimal Lead Composition in Phase I, the Goal of Phase Ii Is to Establish GMP, Conduct Pre-clinical Immuno- Toxicology Studies, and to Complete Key Steps to Supporting Ind Submission. Our Aims Are to: Aim 1: Establish GMP Manufacturing for Our Vaccine Regimen. Aim 2: to Complete Pre-clinical Immuno-toxicity Studies to Support an Ind Application. Aim 3: Complete Key Steps to Support Ind-filing at End of Funding.