Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and
globally integrated biopharmaceutical company is pleased to advise
our Chief Executive Officer, Steven Lydeamore together with our
Chief Scientific Officer, Dr. Jerry Kanellos and Research &
Development Manager, Dr. Joanne Casey will be hosting a Live
Virtual Event on Tuesday, April 30 at 10am AEST / Monday, April 29
at 8pm EDT.
TRAVELAN® BOUND FOR PHASE 3 CLINICAL
TRIALSExploring Immuron’s Positive Phase 2
Travelan® Results and Upcoming Phase 3 Trial
We’d like to invite shareholders and potential
investors to Immuron Ltd’s (ASX:IMC) / (NASDAQ:IMRN) upcoming
Virtual Symposium!
Join Steve Lydeamore, CEO Immuron, Dr. Joanne
Casey, R&D Manager Immuron, and Dr. Jerry Kanellos, CSO
Immuron, as they explore the Company’s positive Phase 2 Travelan®
(IMM-124E) results, upcoming Phase 3 trial, proprietary technology
behind Immuron’s success, and more.
Last month, Immuron, a globally integrated
biopharmaceutical company focused on developing and commercializing
oral immunotherapeutics for the treatment of gut mediated diseases,
reported positive interim topline results from its Phase 2 trial of
Travelan. The study's findings indicated protective efficacy
against enterotoxigenic Escherichia coli (ETEC)-induced diarrhea, a
common and debilitating condition affecting travelers, and adds
additional data to the established excellent safety and
tolerability profile of Travelan. Remarkably, there was a 83.3%
reduction in the number of participants requiring early antibiotic
treatment compared to placebo and 100% of participants requiring IV
fluids were in the placebo group.
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 tract and can be used to target viruses or
bacteria and neutralize the toxins they produce at mucosal
surfaces.
In the clinical study, predominantly funded by a
US$3.43 million grant from the US Department of Defense, Travelan
demonstrated a 36.4% reduction in cases of moderate to severe
diarrhea and a remarkable 66.7% efficacy against severe diarrhea
instances, compared to placebo. This Phase 2 clinical trial was a
randomized, double-blind, placebo-controlled study.
With 30% to 70% of travelers experiencing
traveler’s diarrhea, according to the CDC, the traveler’s diarrhea
treatment market is large and growing at a CAGR of ~7%. According
to a Lumanity Opportunity Assessment for IMM-124E, based on the
estimated market size and pricing, the base case yearly revenue in
USA for IMM-124E is projected at US$102M.
Immuron will now proceed to hold an end of Phase
2 meeting with the FDA to discuss the pivotal Phase 3 registration
strategy as well as explore funding for Phase 3. By merely entering
Phase 3, Immuron will be among an exclusive list of ASX biotech
stocks in Phase 3.
At this webinar, you can expect an insightful
exploration into the results, upcoming milestones to come from
Immuron, and other research and development pathways the Company is
pursuing as it works to realize the full potential of its
proprietary technology platform.
We hope to see you on Tuesday, April 30 at 10am
AEST / April 29 at 8pm ET.
Register
Today:https://www.linkedin.com/events/7180999382673018882/about/
This release has been authorised by the
directors of Immuron Limited.
COMPANY CONTACT:
Steven LydeamoreChief Executive
Officersteve@immuron.com
About ImmuronImmuron 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.
About Travelan®Travelan® is an
orally administered passive immunotherapy that prophylactically
reduces the likelihood of contracting travelers’ diarrhea, a
digestive tract disorder that is commonly caused by pathogenic
bacteria and the toxins they produce. 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 tract
protection.
Travelers’ diarrhea (TD)TD is
generally defined as the passage of ≥ 3 unformed stools per 24
hours plus at least one additional symptom (such as nausea,
vomiting, abdominal cramps, fever, blood/mucus in the stools, or
fecal urgency) that develop while abroad or within 10 days of
returning from any resource-limited destinations (Leung et al.,
2006). Diarrhea continues to be the most frequent health problem
among travelers to destinations in lower- and middle-income regions
(Steffen, 2017). Deployed US military personnel, essentially
representing a long-term traveller population, are particularly
affected given their population dynamics and the context in which
they seek care and treatment (Connor et al., 2012). Diarrhea is the
leading infectious disease threat to the overall health and
preparedness of deployed US armed forces, with diarrheagenic E.
coli, Campylobacter spp., and Shigella spp. among the most commonly
reported etiologies (Riddle et al., 2006).
Immuron Platform
TechnologyImmuron’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.
IMM-124EIMM-124E was developed
using Immuron’s platform technology. IMM-124E is produced from the
colostrum of birthing cattle that have been immunised during
pregnancy with a vaccine containing the outer antigens of multiple
human derived ETEC. 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 strains of ETEC.
The resultant hyperimmune colostrum IMM-124E
from ETEC vaccinated cows contains significant levels of polyclonal
antibodies specific for ETEC antigens LPS, CFA-I and Flagellin
(Sears et al., 2017).
The antibodies produced in IMM-124E have been
found to have a stronger binding and neutralizing activity (than
the antibodies of unvaccinated cattle) against a wide range of LPS
antigens including both the variable O-polysaccharide region and
the preserved oligosaccharide core ‘R’ region of LPS from the 13
serotypes used in the ETEC vaccine.
IMM-124E is manufactured into a tablet form
referred to as Travelan®.
ReferencesConnor P, Porter CK,
Swierczewski B and Riddle MS. Diarrhea during military deployment:
current concepts and future directions. Curr Opin Infect Dis.
25(5): 546-54; 2012.
Leung AK, Robson WL, Davies HD. Travelers’
diarrhea. Adv Ther. Jul-Aug; 23(4): 519-27; 2006
Otto W, Najnigier B, Stelmasiak T and
Robins-Browne RM. Randomized control trials using a tablet
formulation of hyperimmune bovine colostrum to prevent diarrhea
caused by enterotoxigenic Escherichia coli in volunteers
Scandinavian Journal of Gastroenterology 46: 862– 868; 2011.
Riddle MS, Sanders JW, Putnam SD, and Tribble
DR. Incidence, etiology, and impact of diarrhea among long-term
travelers’ (US military and similar populations): A systematic
review. American Journal of Tropical Medicine and Hygiene. 74(5):
891-900; 2006.
Sears KT, Tennant SM, Reymann MK, Simon R,
Konstantopolos N, Blackwelder WC, Barry EM and Pasetti MF.
Bioactive Immune Components of Anti-Diarrheagenic Enterotoxigenic
Escherichia coli Hyperimmune Bovine Colostrum products. Clinical
and Vaccine Immunology. 24 (8) 1-14; 2017.
Steffen R. Epidemiology of travelers' diarrhea.
J Travel Med. 24(suppl_1): S2-S5; 2017.
For more information visit:
https://www.immuron.com.au/ and https://www.travelan.comSubscribe
for Immuron News: Here
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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