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Immuron Ltd — Investor Presentation 2023
Jul 23, 2023
35121_rns_2023-07-23_7ca08349-50be-4c7d-aefd-9923b342a758.pdf
Investor Presentation
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Immuron CEO, Steven Lydeamore to present at Bioshares
Melbourne, Australia, July 24, 2023: Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to advise our Chief Executive Officer, Steven Lydeamore will be presenting at the 17th Bioshares Biotech Summit in Hobart on July 24[th] .
A copy of the presentation being made at the 17th Bioshares Biotech Summit is included below.
This release has been authorised by the directors of Immuron Limited.
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COMPANY CONTACT:
Steven Lydeamore Chief Executive Officer Ph: +61 (0)3 9824 5254 [email protected]
About Travelan®
Travelan® is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting traveller’s diarrhoea, a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce. Travelan® is a highly purified tabletised preparation of hyperimmune bovine antibodies and other factors, which when taken with meals bind to diarrhoea-causing bacteria and prevent colonisation and the pathology associated with traveller’s diarrhoea. 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 Traveller’s Diarrhoea, reduce the risk of minor gastrointestinal disorders and is antimicrobial. In Canada, Travelan® is a licensed natural health product (NPN 80046016) and is indicated to reduce the risk of Traveller’s Diarrhoea. In the U.S., Travelan® is sold as a dietary supplement for digestive tract protection.
About Traveller’s Diarrhoea
Traveller’s Diarrhoea 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 Traveller’s Diarrhoea as they may be contracted while travelling and initial symptoms are often indistinguishable.
About Immuron
Immuron Limited (ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company focused on developing and commercialising orally delivered targeted polyclonal antibodies for the treatment of infectious diseases.
For more information visit: http://www.immuron.com
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FORWARD-LOOKING STATEMENTS:
This 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.
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BIOSHARES PRESENTATION 24 JULY, 2023 - Steven Lydeamore CEO NASDAQ: IMRN ASX: IMC
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SAFE HARBOR STATEMENT
Certain statements made in this presentation are forward -looking statements and are based on Immuron’s current expectations, estimates and projections. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “guidance” and similar expressions are intended to identify forward -looking statements.
Although Immuron believes the forward-looking statements are based on reasonable assumptions, they are subject to certain risks and uncertainties, some of which are beyond Immuron’s control, including those risks or uncertainties inherent in the process of both developing and commercializing technology. As a result, actual results could materially differ from those expressed or forecasted in the forward-looking statements.
The forward-looking statements made in this presentation relate only to events as of the date on which the statements are made. Immuron will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this presentation except as required by law or by any appropriate regulatory authority.
FY2023 results in this presentation are subject to audit review.
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TOPICS
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Immuron Overview
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US Department of Defense interest in Immuron Technology
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Immuron’s DoD partnered programs
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Commercial path forward if Travelan® Phase 2 study is successful
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Partnering with the US Department of Defense
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EXECUTIVE SUMMARY
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Immuron Ltd (NASDAQ:IMRN) (ASX:IMC) is a globally integrated biopharmaceutical company focused on developing, and commercialising, oral immunotherapeutics for the treatment of gut mediated diseases
- Two commercially available oral immunotherapeutic products – Travelan® and Protectyn®
Company
Overview
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4 clinical programs – Travelan® (Sponsor: Immuron), CampETEC (Sponsor: US Department of Defense), IMM-529 (Sponsor: Immuron), Travelan® (Sponsor: US Department of Defense)
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Market capitalisation of A$17.3m as of 19 Jul 23 with cash & cash equivalates balance of $18.5 million as of 31 Dec 22
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Flagship product Travelan® growing strongly as overseas travel rebounds
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Travelan® (IMM-124E) IND filed with and approved by FDA
Business Update
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Travelan® (IMM-124E) Phase 2 clinical trial initiated
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Travelan® Uniformed Health Services University P2TD IMM-124E field clinical trial recruited ~300 (>35% of target 868)
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CampETEC IND approved (released from Clinical Hold)
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FY23 sales of A$1.80 million up 136% on FY22 (subject to audit review)
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Evaluating options to enter Asian and European markets through distributors
Results &
- Evaluating options to add to marketed products portfolio in FY24
Outlook
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ADDRESSABLE MARKET & INDUSTRY OVERVIEW
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Billion Dollar Market
Traveller’s diarrhoea treatment market is large and growing at a CAGR of ~7%
Industry tailwinds
Travel picking up significantly following COVID lockdowns
Frequent Symptom
30% - 70% of travelers experience traveller’s diarrhoea**
$83m $50m $1.7b USA Market Chief Commercial Based on US annual Based on EU travel Clostridioides difficile Evaluating options: Officer has 20+ year’s • travel numbers and a numbers and a infections (CDIs) to amazon.com shopfront for entry into Asia experience with local penetration rate of penetration rate of grow to almost $1.7 launch 1QFY24 and Europe and global (Asia, UK) Re-entry into retail • to add marketed 15%, the market 15%, the market billion by 2026, commercial leadership potential is estimated potential is estimated according to pharmacies will be products to roles with GSK and at $83m at $50m GlobalData explored in FY24 portfolio in FY24 P&G
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* IMC Company Report - Travelan Market Analysis 2019
** Centers for Disease Control and Prevention Yellow Book
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TECHNOLOGY PLATFORM
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Bovine colostrum is the first milk of cows after calving. It is rich in immunoglobulins, lactoferrin, lysozyme, lactoperoxidase, growth factors and bioactive peptides. Colostrum has higher levels of protein, fat, vitamins, and minerals when compared to milk. This enables full development of the newborn calf in addition to immunity against several pathogens.[*]
Immuron’s proprietary technology platform combines the natural human nutrition & health benefits of bovine colostrum with a novel class of specifically targeted oral polyclonal antibodies that offer delivery within the gastrointestinal (“GI”) tract and can be used to target viruses or bacteria and neutralize the toxins they produce at mucosal surfaces.
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STEP 1
Development of Highly Specific Vaccines
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STEP 2
STEP 3
Isolation of Hyperimmune Oral Antimicrobial antibody-rich therapeutics bovine colostrum without drawbacks of antibiotics
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FINAL PRODUCT
Toxin Neutralization +
Clearance of targeted gut pathogens
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✓ Reduce occurrence and reduce/relieve diarrhoea
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✓ Reduce/relieve abdominal cramping
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✓ Reduce/relieve gastrointestinal pain
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✓ Assists repair of
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gastrointestinal/gut wall lining
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✓ Enhance/promote immune defence
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✓ Enhance/promote health liver function
Australian Permitted indications; these statements have not been evaluated by the Food and Drug Administration (FDA)
* Gomes et. al., NFS Journal, Volume 25, November 2021, pages 1- 11, https://doi.org/10.1016/j.nfs.2021.10.001
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US DEPARTMENT OF DEFENSE
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Managed by the Department of Defense collaborating with multiple government agencies
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Focuses on development of medical solutions to protect, treat, and optimize health and performance of U.S. military personnel and civilians
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Focuses on innovative medical solutions to a range of Force Health Protection and Readiness challenges currently facing U.S. Service Members, along with threats anticipated during future operations
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Created a model of vaccine and therapeutic development that is unique, nimble, and responsive to dynamically evolving infectious disease threats of military importance
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ARMED FORCES RESEARCH INSTITUTE OF MEDICAL SCIENCES
- Optimize soldier lethality by developing solutions to infectious diseases capability gaps through product development and surveillance research in Asia
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- NMRC’s mission is to conduct health and medical research, development, testing, evaluation, and surveillance to enhance deployment readiness of DoD personnel worldwide
NAVAL MEDICAL RESEARCH COMMAND
- NRMC focuses on solutions to operational medical problems such as battlefield neurotrauma and wound infections, decompression sickness, naturally occurring infectious diseases , and biological threat agents; and is home to the DoD bone marrow registry
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- Coordinates, initiates, and supports research related to military health needs based on a holistic framework of health that includes prevention, resilience, treatment, recovery, rehabilitation, reintegration, and the overall well-being of the warfighter, as well as dual benefit outcomes that will improve civilian health. Our team advances research and collaborations utilizing several mechanisms, to include grants and a variety of cooperative agreements.
UNIFORMED SERVICES UNIVERSITY
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The views expressed in this presentation are those of the author and do not necessarily reflect the official policy or position of the Department of the Army, Department of the Navy, Department of Defense, nor the U.S. Government
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US ARMY MEDICAL RESEARCH & DEVELOPMENT COMMAND
Key Commentary
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• US Military Infectious Diseases Research Program (MIDRP)
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The mission of the MIDRP is to plan, coordinate and oversee for the US DOD requirements-driven medical solutions that PREVENT, PREDICT, and TREAT infectious diseases threats
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Diarrheal disease is the leading infectious threat facing deployed U.S. Military
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Effective vaccines are the most suitable preventive measure for infectious diarrheal diseases but there are no licensed products available
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Enteric countermeasure products need to provide protection against military-relevant enteric pathogens
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The DoD is working with Immuron to develop products with coverage for Shigella , Campylobacter and multiple ETEC phenotypes and is investigating the possibility of increasing coverage to other pathogens including enteroaggregative E. coli (EAEC)
Military Infectious Diarrhea Etiological Agents
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The views expressed in this presentation are those of the author and do not necessarily reflect the official policy or position of the Department of the Army, Department of the Navy, Department of Defense, nor the U.S. Government
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US DOD R&D COLLABORATION AGREEMENTS
NMRC AFRIMS WRAIR
Travelan®(ETEC)
Established
Campylobacter
Shigella
Developing
Australian Packaging
Key Commentary USA Packaging
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- Immuron partnered with AFRIMS, NMRC & WRAIR to test Travelan® against Campylobacter, ETEC, Shigella and Vibrio cholera
US Department of Defense grant of US$4.45 million to examine a dosing regimen for Travelan® more suited for use by the military
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IMM-124E (Travelan®) IND was approved by the FDA in December 2022
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• Initiated clinical trial May 2023: NCT05933525
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Walter Reed Army Institute of Research – June 2016
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Armed Forces Research Institute of Medical Sciences (AFRIMS) – June 2016
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Naval Medical Research Command – August 2016
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Travelan® binds 180 pathogenic strains of bacteria from infected personnel deployed in Bhutan, Cambodia, Nepal and Thailand (ETEC, Shigella, Campylobacter)
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Travelan® binds to 71 pathogenic strains of Vibrio cholera from infected personnel in Bangladesh, Cambodia, and Thailand
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Travelan® prevented the development of Shigellosis in 75% of non-human primates receiving therapy
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Travelan® - Uniformed Services University has recruited more than 35% of participants in a randomized clinical trial with Travelan® to evaluate the effectiveness for prophylaxis during deployment or travel to a high traveler’s diarrhea risk region
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NCT04605783
Naval Medical Research Command Clinical Trials of CampETEC in campylobacter and enterotoxigenic E.coli (ETEC)
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Animal ethics approval for Toxicology study – 22 November 2022
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Immuron sponsored Toxicology study - completed 20 December 2022
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FDA removed Clinical Hold on Campylobacter ETEC – 8 May 2023
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The views expressed in this presentation are those of the author and do not necessarily reflect the official policy or position of the Department of the Army, Department of the Navy, Department of Defense, nor the U.S. Government
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TRAVELAN® DRUG DEVELOPMENT PLAN
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Travelan® for FDA approval as biologic to reduce the risk of traveller’s diarrhoea (TD) in travellers to endemic areas:
DoD-supported challenge trial
✓ ✓ File IND with Plan for DoubleExecute Field Assimilate Data Hold Pre-IND Blind, PlaceboTrial and File Controlled Field to Support IND Meeting to Registration Submission to Discuss Merits of Trial(s) in Package Travelers to TDFDA Application Endemic Areas
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The views expressed in this presentation are those of the author and do not necessarily reflect the official policy or position of the Department of the Army, Department of the Navy, Department of Defense, nor the U.S. Government
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TRAVELAN® DRUG DEVELOPMENT PLAN
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Travelan® sits around Milestone B. In applying for the MTEC grant, Immuron had a high TRL rating.
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The views expressed in this presentation are those of the author and do not necessarily reflect the official policy or position of the Department of the Army, Department of the Navy, Department of Defense, nor the U.S. Government
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PARTNERING WITH US DEPARTMENT OF DEFENSE
- Join funding consortiums like MTEC which the U.S. Army Medical Research and Development Command (USAMRDC) and other DoD agencies offer funding opportunities to members through solicitations called Requests for Prototype Proposals (RPPs): https://mtec-sc.org/how-to-join/
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Register on the various U.S. Government / DoD grant funding platforms as
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a Nontraditional Defense Contractor :
http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10section3014&num=0&edition=prelim
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The System for Award Management (SAM.gov) is an official website of the
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U.S. Government . https://sam.gov/content/home
MTEC Membership Note: In order to respond to any solicitation
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•There is no cost to use SAM.gov. You can use this site to:
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Register to do business with the U.S. Government
on this site, you must be a member of the MTEC Consortium .
- Search for contract opportunities
Solicitations include awards from:
- Access publicly available awards
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• Understand the terms and processes , e.g.
Military Infectious Diseases Research Program (MIDRP) Combat Casualty Care Research Program (CCCRP)
Military Operational Medicine Research Program (MOMRP)
Clinical and Rehabilitative Medicine Research Program (CRMRP)
Medical Simulation and Information Sciences Research Program (MSISRP)are Research Program (CCCRP)
Military Operational Medicine Research Program
- Technology Readiness Levels: https://mtec-sc.org/wpcontent/uploads/2016/12/TRL-definitions.pdf
• Grant application and approval process :
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https://research.uga.edu/docs/units/dsc/MTEC-Proposal-PreparationGuide.pdf
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Connect with DoD leadership at USAMRDC and others like the US Military
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Infectious Diseases Research Program (MIDRP); key decision-making bodies for future solicitations; membership of MTEC facilitates this
(MOMRP)
(CRMRP) The views expressed in this presentation are those of the author and do not necessarily reflect the official policy or position of the Department of the Army, Department of the Navy, Department of Defense, nor the U.S. Government Medical Simulation and Information Sciences Research
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STEVEN LYDEAMORE CHIEF EXECUTIVE OFFICER IMMURON LIMITED CONTACT INFORMATION:
EMAIL: [email protected] PHONE: AUSTRALIA: +613 8892 4854
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|SCIENTIFIC REFERENCES|
|Travelan® (IMM-124E)|
|Travelan® has been shown to reduce both the incidence and severity of ETEC-induced diarrhea in up to 90% of|Scandinavian Journal of Gastroenterology, 46:7-8, 862-868, DOI:|
|volunteers|10.3109/00365521.2011.574726|
|Travelan as a broad Spectrum anti-bacterial|Immuron Limited, 29 April, 2011|
|Travelan® demonstrates broad reactivity to Vibrio cholera strains from Southeast Asia indicating broad potential|US Department of Defense, Armed Forces Research Institute of Medical|
|for prevention of traveler’s diarrhea|Sciences (AFRIM), 4 September, 2019|
|Travelan® prevented clinical shigellosis (bacillary dysentery) in 75% of Travelan® treated animals compared to|US Department of Defense, Armed Forces Research Institute of Medical|
|placebo and demonstrated a significant clinical benefit|Sciences (AFRIM), 5 September, 2018|
|Travelan® able to bind and was reactive to 60 clinical isolates of each bacteria, Campylobacter, ETEC, and Shigella|US Department of Defense, Armed Forces Research Institute of Medical|
|Sciences (AFRIM), 30 January, 2017|
|Efficacy of hyperimmune bovine colostrum against shigellosis in rhesus macaque (Macaca mulatta), and|Islam et al., 2020. Submitted to mSphere, American Society for Microbiology|
|bioactivity of HBC against common enteric pathogens|
|Bioactive Immune Components of Travelan®|Clin Vaccine Immunol 24:e00186-16. https://doi.org/10.1128/CVI.00186-16|
|Hyperimmune bovine colostrum containing lipopolysaccharide antibodies (IMM-124E) has a non-detrimental|Rachele Gore, Mitra Mohsenipour, Jennifer L Wood, Gayathri K Balasuriya,|
|effect on gut microbial communities in unchallenged mice|Elisa L Hill-Yardin, Ashley E Franks|
|Administration of the Hyper-immune Bovine Colostrum Extract IMM-124E Ameliorates Experimental Murine|Journal of Crohn's and Colitis, Volume 13, Issue 6, June 2019, Pages 785–797,|
|Colitis|https://doi.org/10.1093/ecco-jcc/jjy213|
|IMM-529|
|Bovine antibodies targeting primary and recurrent Clostridium difficile disease are a potent antibiotic alternative|Sci Rep 7, 3665 (2017). https://doi.org/10.1038/s41598-017-03982-5|
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PARTNERING WITH US DEPARTMENT OF DEFENSE LEARN YOUR ACRONYMS
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| Acronyms | Abbreviations | Acronyms | Abbreviations |
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| ACURO | Animal Care and Use Review Office | NAMD | Naval Advanced Medical Development |
| ATI | Advanced Technology International | NDC | Nontraditional Defense Contractor |
| DUNS | Data Universal Numbering System | NMRC | Naval Medical Research Command |
| HRPO | Human Research Protection Office | OHRO | Office of Human Research Oversight |
| IACUC | Institutional Animal Care and Use Committee |
ROM RPP |
Rough Order of Magnitude Request for Project Proposals |
| KRL | Knowledge readiness level | TRL | Technology readiness level |
| MTEC | Medical Technology Enterprise Consortium |
USAMRDC | U.S. Army Medical Research and Development Command |
| MIDRP | Military Infectious Diseases Research Program |
WRAIR | Walter Reed Army Institute of Research |
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The views expressed in this presentation are those of the author and do not necessarily reflect the official policy or position of the Department of the Army, Department of the Navy, Department of Defense, nor the U.S. Government
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