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New U.S. Department of Defense Research Collaboration with Immuron to Develop and Clinically evaluate a New Therapeutic against Campylobacter Key Highlights: AU $5.5 (USD $3.7) million funding approved by the U.S. Depart

Key Takeaway: U.S. Department of Defense Research Collaboration with Immuron to Develop and Clinically evaluate a New Therapeutic against Campylobacter AU $5.5 (USD $3.7) million funding approved by the U.S. Department of Defense to develop and clinically evaluate a new oral therapeutic tar

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U.S. Department of Defense Research Collaboration with Immuron to Develop and Clinically evaluate a New Therapeutic against Campylobacter
AU $5.5 (USD $3.7) million funding approved by the U.S. Department of Defense to develop and clinically evaluate a new oral therapeutic targeting Campylobacter and ETEC
Naval Medical Research Center will fund the manufacture and therapeutic evaluation of the new therapeutic to protect against acute infectious diarrhea
Two human clinical trials to be conducted with new therapeutic under terms of grant
Australia, October 02, 2019: Immuron Limited (ASX: IMC; NASDQ: IMRN), an Australian biopharmaceutical company focused on developing
and commercializing oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, is pleased to announce
the funding of a new research agreement with the Naval Medical Research Center (NMRC),
Silver Spring, MD, USA.
focus of this new agreement will be to develop a combined Campylobacter and enterotoxigenic E. coli (ETEC)-specific
anti-microbial preventative for clinical evaluation. Under this agreement, Immuron and NMRC will be collaborating on the
manufacture and evaluation of the new product designed to protect against travelers' diarrhea caused by Campylobacter
and ETEC pathogens. The protective efficacy of the product will be tested utilizing two controlled human infection-model clinical
trials, with one trial focusing on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis,
and the second trial focusing on ETEC infections.
good news is that we just had the confirmation that the funds were transferred, and we are ready and eager to start the project,"
said Dr. Fr d ric Poly, Head of the Campylobacter research division, Enteric Diseases Department at NMRC. "Deployed
military personnel are a unique population of travelers that have a long history of being affected by acute infectious diarrhea.
Campylobacter jejuni and ETEC are leading causes of travelers' diarrhea and represent a major burden for deployed
US troops. And despite robust research efforts to develop vaccines against major enteric pathogens, there are currently no licensed
vaccines available. To address this unmet need, we will be utilizing our own vaccine expertise along with Immuron's proprietary
technology platform to develop an oral preventative product which directly targets pathogenic bacteria at the site of infection
within the gastrointestinal tract. We have previously shown that the ETEC vaccine is immunogenic in small animal models and demonstrated
that Campylobacter jejuni vaccines were 100% protective against campylobacteriosis in the non-human primate model. We have
also independently developed a prophylactic anti-diarrheal oral bovine colostrum-derived immunoglobulin product and demonstrated
protective efficacy against an ETEC strain in a controlled human infection model (CHIM)."
Fr d ric Poly of the NMRC goes on to say: "The ultimate goal of this research effort is to lay the scientific
foundation for development of a multi-pathogen product that confers protection against both C. jejuni and ETEC, the predominant
causes of infectious diarrhea in deployed warfighters. Ultimately, the data resulting from these studies will provide military
policymakers with information needed to make decisions on product acquisition and, if successful, Immuron should be enabled to
manufacture the product at scale to meet the needs of military personnel and the traveling community on an ongoing basis."
is wonderful news," said Dr. Gary S. Jacob, CEO of Immuron. "The new project expands our anti-infectious diseases
clinical development program to include this Campylobacter project with the U.S. Department of Defense, covering an additional
key pathogen, Campylobacter, responsible for travelers' diarrhea. Along with our current program with the Walter Reed Army
Institute of Research which is focused on Shigella, this project highlights the continued commitment Immuron is making to use
our hyperimmune bovine polyclonal colostrum technology to benefit the U.S. Military as well as the civilian population. This program
also further enhances our efforts to raise the profile of our flagship product Travelan and our in-house clinical
program to develop IMM-124E as an FDA approved drug to prevent Travelers' Diarrhea."
diarrhea is the most common illness reported by travelers visiting developing countries and among US troops deployed overseas.
Diarrhea morbidity decreases daily performance, affects judgment, decreases morale and declines operational readiness. The first
line of treatment for infectious diarrhea is prescription of antibiotics. Unfortunately, in the last decade, several enteric pathogens
have an increasing resistance to commonly prescribed antibiotics. In addition, travelers' diarrhea is now recognized by the medical
community to result in post-infectious sequelae, including post-infectious Irritable Bowel Syndrome and several post-infectious
autoimmune diseases.
global burden of diarrheal diseases outweighs any of the more complex diseases seen in gastroenterology clinics. Every year, there
are an estimated 1.5 billion episodes of diarrhea worldwide. These episodes result in the deaths of approximately 2.2 million
people, mostly children in developing countries (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2699001/). A
preventative treatment that protects against enteric diseases, specifically shigellosis, is a high priority objective for the
US Army. Shigella spp are estimated to cause 80 -165 million cases of disease worldwide, resulting in 600,000 deaths
annually and is particularly prevalent in both sub-Saharan Africa and South Asia.
Limited (ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company focused on developing and commercializing orally
delivered targeted polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases. Immuron has a novel
and safe technology platform with one commercial asset Travelan generating revenue. Immuron's lead clinical
candidate, IMM-124E, is presently being developed as a drug to prevent Travelers' Diarrhea. Immuron's second clinical-stage
asset, IMM-529, targets Clostridium difficile Infections (CDI), and is presently in a clinical trial in CDI patients. These
products together with the Company's other preclinical immunotherapy pipeline products currently under development targeting
immune-related and infectious diseases are anticipated to meet pressing needs in the global immunotherapy market.
more information visit: http://www.immuron.com
is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting travelers'
diarrhea. Travelan is a highly purified tabletized preparation of hyper immune bovine antibodies and other factors,
which when taken with meals bind to diarrhea-causing bacteria and prevent colonization and the pathology associated with travelers'
diarrhea. In Australia, Travelan is a listed medicine on the Australian Register for Therapeutic Goods (AUST L
106709) and is indicated to reduce the risk of Travelers' Diarrhea, reduce the risk of minor gastro-intestinal disorders
and is antimicrobial. In Canada, Travelan is a licensed natural health product (NPN 80046016) and is indicated
to reduce the risk of Travelers' Diarrhea. In the U.S., Travelan is sold as a dietary supplement for digestive
diarrhea is a gastrointestinal infection with symptoms that include loose, watery (and occasionally bloody) stools, abdominal
cramping, bloating, and fever, Enteropathogenic bacteria are responsible for most cases, with enterotoxigenic Escherichia coli
(ETEC) playing a dominant causative role. Campylobacter spp. are also responsible for a significant proportion of cases. The
more serious infections with Salmonella spp. the bacillary dysentery organisms belonging to Shigella spp. and Vibrio spp. (the
causative agent of cholera) are often confused with travelers' diarrhea as they may be contracted while travelling and initial
symptoms are often indistinguishable.
press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of
1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to,
any statements relating to our growth strategy and product development programs and any other statements that are not historical
facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties
that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual
results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain,
perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and
development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical
and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the
early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual
property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking
to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations
or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Last updated: Oct 2, 2019