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Immuron Announces New U.S. Department of Defense Research Award for Naval Medical Research Command and Walter Reed Army Institute of Research to advance Travelan®
Highlights:
$3.5 (USD $2.3) million funding for NMRC and WRAIR approved by the U.S. Department of Defense to advance the development of Travelan.
Melbourne, Australia, August 16, 2024: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to announce the funding of a new research agreement for the Naval Medical Research Command (NMRC), and Walter Reed Army Institute of Research (WRAIR) Silver Spring, MD, USA.
The focus of this new research agreement is to develop an enhanced formulation of Travelan potentially expanding the coverage of the product as a therapeutic measure against endemic military relevant diarrheal pathogens. This work will utilize the extensive experience of the US Department of Defense human infectious disease vaccine programs and will target key protective antigens of the major enteric bacterial pathogens Campylobacter, Shigella and Entertoxigenic E. coli strains not present in the current product formulation.
Immuron will now negotiate a sub award for collaboration with NMRC and WRAIR to advance this research.
The U.S Department of Defense has recognized the benefits of Immuron’s technology platform and has an established long-standing relationship with Immuron to evaluate the commercial over-the-counter bovine colostrum product Travelan for its specificity and effectiveness against diarrheal pathogens. As an extension of the current Shigella (WRAIR), ETEC and Campylobacter (NMRC) research programs the goal of this award is to identify and define pathways to formulate, characterize and perform pre-clinical testing of a military-relevant combined colostrum product.
Infectious diarrhea is the most common illness reported by travelers visiting developing countries and among US troops deployed overseas as indicated by the 2019 Department of Defense (DoD) Infectious Disease Threats Prioritization Panel. The morbidity and associated discomfort stemming from diarrhea decreases daily performance, affects judgment, decreases morale and declines operational readiness. The first line of treatment for infectious diarrhea is the prescription of antibiotics. Unfortunately, in the last decade, several enteric pathogens have demonstrated increasing resistance to commonly prescribed antibiotics. In addition, traveler’s diarrhea is now recognized by the medical community to result in post-infectious sequelae, including post-infectious irritable bowel syndrome (IBS) and several post-infectious autoimmune diseases. A preventative treatment that defends against infectious enteric diseases is a high priority objective for the US Military.
Immuron Plans Phase 2 Trial for IMM-529 following FDA review
September 05 2024 - 11:54AM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company, is pleased to announce that it has received favourable feedback from the United States Food and Drug Administration (FDA) on the pre-IND (investigational new drug) information package to support the clinical development of IMM-529.
Following the FDA’s guidance and feedback, the Company now plans to file an investigational new drug (IND) application for IMM-529 to prevent or treat Clostridioides difficile infection (CDI) during the first half of 2025, followed by a Phase 2 trial of IMM-529 in individuals with Clostridioides difficile infection.
The increased incidence of antibiotic resistant ‘superbugs’ has amplified the use of broad-spectrum antibiotics worldwide. An unintended consequence of antimicrobial treatment is disruption of the gastrointestinal microbiota, resulting in susceptibility to opportunistic pathogens, such as Clostridioides difficile (C. diff). Paradoxically, treatment of Clostridioides difficile infection (CDI) also involves antibiotic use, and the heavy reliance on antibiotics to control C. diff does not allow for the gut flora to regenerate and predisposes the patient to relapsing CDI. C. diff is currently the most common pathogen in healthcare-associated infections and was deemed an urgent threat in the Center for Disease Control and Prevention’s report on antibiotic resistance threats in the United States (CDC, 2019). CDI affects over 400,000 people in the US on a yearly basis, contributing to over 30,000 deaths in the US alone annually. This serious health threat has led to an urgent call for the development of new therapeutics to reduce or replace the use of antibiotics to treat bacterial infections.
To address this need, Immuron is developing IMM-529 as an adjunctive therapy in combination with standard of care antibiotics for the prevention and/or treatment of recurrent CDI. IMM-529 antibodies targeting C. diff may help to clear CDI infection and promote a quicker re-establishment of normal gut flora, providing an attractive oral preventative for recurrent CDI.
Immuron is collaborating with Dr. Dena Lyras and her team at Monash University, Australia to develop vaccines to produce bovine colostrum-derived antibodies. Dairy cows were immunised to generate hyperimmune bovine colostrum (HBC) that contains antibodies targeting three essential C. diff virulence components. IMM-529 targets Toxin B (TcB), the spores and the surface layer proteins of the vegetative cells (refer to MOA schematic - below).
This unique 3-target approach has yielded promising results in pre-clinical infection and relapse models, including (1) Prevention of primary disease (80% P =0.0052); (2) Protection of disease recurrence (67%, P <0.01) and (3) Treatment of primary disease (78.6%, P<0.0001; TcB HBC). Importantly IMM-529 antibodies cross-react with whole cell lysates of many different human strains of C. diff including hypervirulent strains.
To our knowledge, IMM-529 is, to date, the only investigational drug that has shown therapeutic potential in all three phases of the disease. https://doi.org/10.1038/s41598-017-03982-5
IMM-529 Mechanism of Action - Clostridioides difficile Infection (CDI)
Opportunity assessment by Lumanity indicates that if efficacious, IMM-529 will be positioned as early in treatment algorithm as payers will allow. Second recurrence appears to be most likely (after one course each of fidaxomicin and vancomycin) but some doctors who treat aggressively or see a patient as being especially high-risk may be willing to turn to IMM-529 even earlier. Up to ~31k patients would be eligible if IMM-529 is positioned at the second recurrence, and up to ~95k patients would be eligible if positioned at the first recurrence. Based on the estimated market size, anticipated payer restrictions, pricing, and competition, base case yearly revenue for IMM-529 is projected at US$93M. The estimate of $93M represents a conservative view of the target patient population (limited to 2nd recurrence and later by trial design and payer coverage) but likely aggressive use (75%) within that target patient population. Greater efficacy may lead to greater use in patients after their first recurrence, increasing the size of the patient population. Even capturing as few as 10% of first recurrence patients adds up to 9,500 patients to the treated pool (potential for some double counting), which could add up to US$48M in yearly revenue. Oral dosing of IMM-529 was viewed as a positive by infectious disease experts, particularly since current advanced CDI treatment approaches (e.g., bezlotoxumab, fecal microbiota transplantation) are expensive and complex in their administration.
This release has been authorised by the directors of Immuron Limited.
COMPANY CONTACT:
Steven Lydeamore
Chief Executive Officer
steve@immuron.com
About Immuron
Immuron Limited (ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of infectious diseases.
Immuron Platform Technology
Immuron’s proprietary technology is based on polyclonal immunoglobulins (IgG) derived from engineered hyper-immune bovine colostrum. Immuron has the capability of producing highly specific immunoglobulins to any enteric pathogen and our products are orally active. Bovine IgG can withstand the acidic environment of the stomach and is resistant to proteolysis by the digestive enzymes found in the Gastrointestinal (GI) tract. Bovine IgG also possesses this unique ability to remain active in the human GI tract delivering its full benefits directly to the bacteria found there. The underlying nature of Immuron’s platform technology enables the development of medicines across a large range of infectious diseases. The platform can be used to block viruses or bacteria at mucosal surfaces such as the Gastrointestinal tract and neutralize the toxins they produce.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0f144d51-c9e9-46ae-93cf-2a7ac93c74d5
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