Immuron Secures US Department of Defense Award for Novel Oral Therapeutics Against Military-Priority Pathogens
核心洞察
Immuron Limited (搜索) has received a new US Department of Defense subaward to develop two oral therapeutics targeting Campylobacter jejuni (搜索) and Shigella sonnei (搜索) using its proprietary hyperimmune bovine colostrum (搜索) platform technology.
The company expects topline results from its completed Uniformed Services University (搜索) clinical trial evaluating IMM-124E (Travelan®) for preventing travelers' diarrhea (搜索) in military personnel to be announced by the end of next week.
The global burden of diarrheal diseases includes an estimated 1.5 billion episodes annually resulting in approximately 2.2 million deaths, with Shigella species causing 80-165 million cases and 600,000 deaths worldwide each year.
Australian biopharmaceutical company Immuron Limited (搜索) has announced a new research agreement with the Naval Medical Research Command (搜索) (NMRC) and Walter Reed Army Institute of Research (WRAIR), funded by a US Department of Defense subaward, to develop two novel oral therapeutics targeting high-priority military pathogens Campylobacter jejuni (搜索) and Shigella sonnei (搜索).
Military-Focused Therapeutic Development
Under the collaborative research agreement with the Henry M. Jackson Foundation, military research institutes have developed and formulated new vaccine preparations against these pathogens, which have been provided to Immuron. The company will utilize its proprietary technology platform to produce two hyperimmune bovine colostrum (搜索) products for pre-clinical evaluation, with the objective of advancing a combined colostrum-based therapeutic specifically designed for US military use.
This development builds on previous collaboration announced on August 16, 2024, where NMRC and WRAIR began progressing novel vaccine development targeting these same pathogens in partnership with Immuron.
Pending Clinical Trial Results
The company expects to announce topline results from the Uniformed Services University (搜索) P2TD clinical study (NCT04605783) by the end of next week. The completed randomized, placebo-controlled trial evaluated the effectiveness of enterotoxigenic E. coli (搜索) (ETEC (搜索)) hyperimmune bovine colostrum (搜索) in maintaining gut health during deployment and travel. IMM-124E, the active ingredient in Travelan®, was administered in 600 mg powder sachets twice daily to study participants.
Addressing Critical Military Health Threat
Infectious diarrhea (搜索) represents the most common illness among travelers to developing countries and US troops deployed overseas. According to the company, diarrhea morbidity decreases daily performance, affects judgment, decreases morale and declines operational readiness. Diarrhea is identified as the leading infectious disease threat to the overall health and preparedness of deployed US armed forces, with diarrheagenic E. coli, Campylobacter species, and Shigella species among the most commonly reported causes.
The growing challenge of antibiotic resistance among enteric pathogens has complicated first-line treatment approaches. Additionally, travelers' diarrhea (搜索) is now recognized to result in post-infectious sequelae, including post-infectious Irritable Bowel Syndrome (搜索) and several post-infectious autoimmune diseases.
Global Disease Burden
The global burden of diarrheal diseases includes an estimated 1.5 billion episodes worldwide annually, resulting in approximately 2.2 million deaths, predominantly among children in developing countries. Shigella species are estimated to cause 80-165 million cases of disease worldwide, resulting in 600,000 deaths annually, with particular prevalence in sub-Saharan Africa and South Asia.
Proprietary Platform Technology
Immuron's technology platform is based on polyclonal immunoglobulins (IgG) derived from engineered hyperimmune bovine colostrum (搜索). The company's bovine IgG can withstand the acidic stomach environment and resist proteolysis by digestive enzymes in the gastrointestinal tract, remaining active to deliver benefits directly to bacteria in the human GI tract.
IMM-124E is produced from colostrum of cattle immunized during pregnancy with a vaccine containing outer antigens of multiple human-derived ETEC (搜索) strains. A total of 13 ETEC strains are used in the vaccine to produce high levels of antibodies against selected surface antigens from the most common ETEC strains. The resultant hyperimmune colostrum contains significant levels of polyclonal antibodies specific for ETEC antigens LPS, CFA-I and Flagellin, demonstrating stronger binding and neutralizing activity against a wide range of LPS antigens compared to antibodies from unvaccinated cattle.