The United States Naval Medical Research Center (NMRC) Silver Spring, MD, has entered into another research agreement with Immuron Limited, (IMRN) an Australian biopharmaceutical company focused on developing and commercialization oral immunotherapeutics for the prevention of gut mediated pathogens. These deals are a vital source of research and development (R&D) capital—additionally, the U.S. military research apparatus represents a critical lifeline for the Australian-based company.
Deal Terms Summary
The deal includes $3.7 million in U.S. Department of Defense funding for the develop and test a new oral therapeutic targeting Campylobacter and ETEC. NMRC is funding the full activities (manufacture and therapeutic evaluation) including two clinical trials.
The global burden of diarrheal diseases outweighs any of the more complex diseases seen in gastroenterology clinics. About 1.5 billion episodes of diarrhea worldwide occur annually. These episodes result in the deaths of about 2.2 million people—mostly children in developing countries. A treatment that protects against enteric diseases, specifically shigellosis represents a high priority objective for the U.S. Army. Shigella spp is estimated to cause 80-165 million cases of the disease worldwide, resulting in 600,000 deaths annually with particular intensity in both sub-Saharan Africa and South Asia.
The R&D Mission: Gut Mediated Pathogens
The parties seek to develop a combined Campylobacter and enterotoxigenic E. coli (ETEC)-specific anti-microbial preventative for clinical evaluation. The two will develop and manufacture the new product designed to protect against travelers’ diarrhea caused by Campylobacter and ETEC pathogens.
The partnership will develop investigational products that will be tested utilizing two controlled human infection-model clinical trials, with one study centered on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis and the second trial focusing on ETEC infections.
Who is Immuron Limited?
Immuron is a publicly-traded company (IMRN on NASDAQ) based in Australia. They focus on the development and commercialization of oral delivered targeted polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases. They have developed one commercial asset based on their novel and save a technology platform called Travelan® which generates revenue. Their lead clinical candidate is IMM-124E, 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. They believe their pipeline is addressing pressing needs in the global immunotherapy market.
Previous Clinical Trials with DOD
Immuron has already entered into a partnership with the U.S. Government via a deal with the Department of Defense to study Travelan in clinical trials. One study showed that Travelan has effective immunological reactivity to dangerous and potentially fatal infectious bacteria. The Department of Enteric Diseases (DED), Armed Forces Research Institute of Medical Sciences (AFRIMS) performed the study. It took place at a laboratory at the Walter Reed Army Research Institute of Research (WRAIR) in Bangkok, Thailand. WRAIR is one of the leading health research organizations worldwide. The study was one of three in a program involving Travelan, looked at 60 clinical isolates of each Campylobacter, Enterotoxigenic Escherichia coli (ETEC) and Shigella from infected U.S. Defense personnel in southeast Asia between 1993 and 2016. The study found that Travelan antibodies were reactive to all 180 clinical isolates tested.
Immuron is a microcap stock. Its present value at $3.03 per share represents a market capitalization of $14.2 million on sales of $1.24 million and losses of $2.1 million according to their 2018 annual report. Total cash and assets are $4.7 million. Their annual report acknowledges the risk of the financial situation noting “the Company currently and since inception, does not receive sufficient income to cover operating expenses. The Company may require additional capital funding in the future.
The DOD to the Rescue?
Of course, many other risks are involved with drug development but their ability to ink a partnership with NMRC infuses needed capital and commercial mission with a highly strategic partner.