Immuron new MTEC project proposal “Development of Oral Immunotherapy for the Prevention of Bacterial Diarrheal Disease”
April 19 2022 - 7:33AM
Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian
biopharmaceutical company focused on developing and commercializing
oral immunotherapeutics for the prevention and treatment of gut
mediated pathogens, is pleased to advise that a new request for
funding has been considered to be eligible for award by the US
Department of Defense funding body ‘Medical Technology Enterprise
Consortium’ (MTEC).
Immuron is pursuing a regulatory pathway to
license Travelan® with the Food and Drug Administration (FDA) via a
Biologics License Application (BLA). The proposed indication is to
reduce the risk of contracting travelers’ diarrhea caused by
bacterial pathogens.
The Company was recently awarded AU$4.8M
(US$3.43M) by MTEC for the development of a Travelan®
dosing regimen acceptable for use by the US military (ASX
announcement 12 January 2022). In this new MTEC request for
funding, Immuron is seeking an additional US$4M to
fund the Investigational New Drug Application, CMC Assay
Development and Validation, Nonclinical Safety Studies and
Stability Studies required to support the BLA.
The focus of this new project proposal is to
develop a self-administered non-vaccine oral immunotherapy to
prevent endemic diarrheal disease by targeting multiple bacterial
pathogens. The oral immunotherapy should mitigate symptoms, shorten
the duration of illness, and/or reduce the risk of contracting
bacterial diarrheal illnesses. The proposed immunotherapy product
will target enterotoxigenic Escherichia coli (ETEC), and at least
one other common bacterial diarrheal pathogen e.g., Campylobacter
spp or Shigella spp.
Immuron was formally notified that no government
funding is immediately available, however, this application has
been deemed ‘eligible for funding’ and will be eligible for award
for a period of up to two years. Dr
Jerry Kanellos,
CEO of Immuron
said, “The current AU$4.8M MTEC funded project was
reviewed similarly and was funded 6 months post eligibility
notification. There is also the potential for additional
noncompetitive funding for follow-on tasks from this RPP to
partially support the planned phase III pivotal registration
clinical studies depending on the success of the project.”
The Company is also pleased to announce that
work on the Investigational New Drug application to evaluate the
efficacy of a single dose regimen of Travelan® in a controlled
human infection model (CHIM) clinical study using the
enterotoxigenic Escherichia coli (ETEC) strain H10407 is
progressing well. The Company has been working with our regulatory
consultants to address the FDA’s guidance and feedback received
following the Type B meeting with the agency and our Navy Medical
Research Centre (NMRC) associates have completed the Travelan ETEC
Clinical trial Synopsis. A mutual Confidentiality Disclosure
Agreement has been executed with a qualified Contract Research
Organization and discussions have been initiated to discuss costs
and timelines for the proposed Travelan clinical study. Up to 60
volunteers will be enrolled in the CHIM clinical study and will be
randomly assigned to receive either a once-daily dose of 1200 mg of
Travelan® or placebo.
Infectious diarrhea is the most common illness
reported by travelers visiting developing countries and amongst US
troops deployed overseas. 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 an increasing resistance to commonly prescribed
antibiotics. In addition, travelers' diarrhea is now recognized by
the medical community to result in post-infectious sequelae,
including post-infectious irritable bowel syndrome and several
post-infectious autoimmune diseases. A preventative treatment that
protects against enteric diseases, is a high priority objective for
the US Military.
This release has been authorised by the Directors of Immuron
Limited.
COMPANY
CONTACT:Dr Jerry
Kanellos, Ph.D. Chief Executive
Officer Ph: +61 (0)3 9824 5254info@immuron.com
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