US DoD Naval Medical Research Center Reports Positive Immunological Responses to Vaccine
November 11 2020 - 6:00AM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), 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 characterisation
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 which 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 hemoglutination 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 their
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 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 authorised by the
directors of Immuron Limited.
COMPANY
CONTACT:Dr
Jerry Kanellos, Ph.D.Chief Executive OfficerPh: +61 (0)3
9824 5254info@immuron.com |
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