Multivalent adjuvant immunization to prevent hospital acquired infections

Ended Project Grant Awarded Last action

Award ID
R42AI145759
Recipient
Awarding agency
Obligated
$4,952,537

Award facts

Assistance listing
93.855 Allergy and Infectious Diseases Research
Completion date
Originally
Place of performance
Maryland, USA

Award details come from USAspending.gov.

Description

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.

Transactions

Action Obligated Date
Amendment $0
Amendment $0
Amendment $983,543
Amendment $989,399
Amendment $989,399
Amendment $995,098
Original award $995,098

Quick answers

Who received award R42AI145759?

R42AI145759 was awarded to Exbaq LLC by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on February 10, 2020.

How much is award R42AI145759 worth?

$4,952,537 has been obligated on R42AI145759.

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