Immuron new MTEC project proposal “Development of Oral Immunotherapy for the Prevention of Bacterial Diarrheal Disease”

Rhea-AI Summary

Immuron Limited (ASX: IMC; NASDAQ: IMRN) has made significant progress in its bid for additional funding from the U.S. Department of Defense. The company is seeking AU$5.4M (US$4M) for its Travelan product, deemed eligible for award. The Investigational New Drug application is advancing, with plans for a clinical trial involving 60 healthy volunteers in the USA. This trial will focus on preventing travelers' diarrhea caused by bacterial pathogens, amidst concerns regarding antibiotic resistance and the need for effective preventive treatments.

Positive

• Request for AU$5.4M (US$4M) funding deemed eligible for award from U.S. Department of Defense.
• Advancement of Investigational New Drug application for Travelan.
• Plans for a clinical trial in 60 healthy volunteers demonstrate commitment to product development.

Negative

• No immediate government funding available despite eligibility for award.
• Dependence on noncompetitive funding for future studies creates uncertainty.

Key Highlights:

• Immuron’s request for AU$5.4M (US$4M) additional funding from the U.S. Department of Defense for Travelan considered to be ‘eligible for award’
• Travelan Investigational New Drug (IND) application advances
• Clinical trial Synopsis complete and plans in place to conduct a controlled human infection model (CHIM) clinical trial in 60 healthy volunteers in the USA
  

MELBOURNE, Australia, April 19, 2022 (GLOBE NEWSWIRE) -- 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 5254
info@immuron.com

FAQ

What funding has Immuron requested from the U.S. Department of Defense for Travelan?

Immuron has requested AU$5.4M (US$4M) in additional funding, which has been deemed eligible for award.

What is the purpose of the Travelan clinical trial?

The clinical trial aims to evaluate the efficacy of Travelan in preventing travelers’ diarrhea caused by bacterial pathogens.

How many volunteers will participate in the Travelan clinical trial?

Up to 60 healthy volunteers will be enrolled in the Travelan clinical trial.

What is the current funding situation for Immuron?

Immuron was notified that no government funding is immediately available, though its funding application has been deemed eligible for award.

What type of product is Immuron developing with Travelan?

Travelan is a self-administered non-vaccine oral immunotherapy targeting bacterial pathogens that cause diarrhea.