Immuron Limited, an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, today is pleased to announce that the Naval Medical Research Center (NMRC) has completed the characterization of the colostrum harvested from cows immunized with the experimental vaccine developed to target Campylobacter and Enterotoxigenic E.coli (ETEC).
The NMRC confirmed that the conjugated vaccine produced a robust immunological response in cows and reported that the new Hyper-immune therapeutic contains high levels of antibodies that specifically target Campylobacter jejuni capsule and Enterotoxigenic Escherichia coli (ETEC) colonization factor antigen 1 (CFA/1). These are key antigenic targets predicted to be protective against diarrhea induced by both pathogens. The US DoD noted that the colostrum contained high levels of specific immunoglobulins against the target antigens in the vaccine and furthermore, was shown to contain functional antibodies capable of inducing hemagglutination inhibition of the CFA/1 specific ETEC strain to be used in one of the two planned controlled human infection-model clinical trials scheduled for next year.
PCI Clinical Services has been contracted to manufacture the drug product against Campylobacter and ETEC for clinical evaluation by the US Department of Defense. The manufacturing campaign is scheduled to commence this month and be completed by the end of 2020.
Work on the Investigational New Drug (IND) application and the clinical protocols for evaluating the safety and efficacy of the product in moderate to severe campylobacteriosis and Enterotoxigenic Escherichia coli (ETEC) infections is progressing well. The NMRC plans to file the IND application with the U.S. Food and Drug Administration (FDA) in Q1 2021.
The ability of the new hyperimmune product to protect volunteers from moderate to severe campylobacteriosis and ETEC disease will be assessed during two inpatient clinical trials planned for Q2 and Q3 2021. A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the study and randomly assigned to either Cohort 1 C. jejuni or Cohort 2 ETEC controlled human infection models.
Infectious diarrhea is the most common illness reported by military personnel deployed overseas and by travelers visiting developing countries. Diarrhea morbidity decreases daily performance, affects judgment, decreases morale, and declines operational readiness. In addition, travelers' diarrhea is now also recognized by the medical community to result in post-infectious sequalae, including post-infectious Irritable Bowel Syndrome and several post-infectious autoimmune diseases.
The US Department of Defense has recognized the burden of infectious diarrhea and has heavily invested in the development of effective vaccines for its prevention. However, despite robust research efforts made to develop vaccines against major enteric pathogens, there are currently no licensed vaccines available. Development of an effective, safe, and affordable prophylactic agent to control infectious diarrhea would offer a useful product for travelers and military personnel going to high-risk areas in Latin America, Africa, the Middle East, and Asia.
The major goal of this research effort is to lay the scientific foundation for the development of a multi-pathogen anti-diarrheal colostrum supplement that confers protection against Campylobacter jejuni and ETEC, the predominant causes of infectious diarrhea in travelers visiting developing countries and among military personnel deployed overseas. Ultimately, the data resulting from these studies will provide military policymakers with information needed to make decisions on product acquisition and stocking.
This release has been authorized by the directors of Immuron Limited.