Immuron Partners with CSIRO to produce a new oral therapeutic for clinical evaluation by the US Department of Defense

Rhea-AI Summary

Immuron Limited (ASX: IMC; NASDAQ: IMRN) has announced significant advancements in its research collaboration with the Naval Medical Research Center (NMRC) and CSIRO. The company signed a research agreement with CSIRO to develop a therapeutic targeting Campylobacter and ETEC for clinical evaluation. Furthermore, NMRC submitted a Pre-IND package to the FDA, anticipating comments within 30 days. A vaccination program has commenced, and two human phase II clinical trials are scheduled for 2021, focusing on protecting against campylobacteriosis and ETEC infections.

Positive

• Executed research agreement with CSIRO for therapeutic development.
• Progress on Pre-IND submission to FDA, with comments expected within 30 days.
• Vaccination program has been initiated for clinical evaluation.
• Plans for two human phase II clinical trials in 2021.

Negative

• None.

Key Points

• Immuron executes a Research Agreement with The Henry M. Jackson Foundation for Advancement of Military Medicine Inc.
• Immuron executes a Research Agreement with CSIRO to develop a new oral therapeutic targeting Campylobacter and ETEC for clinical evaluation
• Vaccination program initiated
• NMRC submits Pre-Investigational New Drug (IND) information package to FDA
• NMRC plans to file an IND application with FDA
• Two human phase II clinical trials to be conducted in 2021
• One trial will focus on the ability of the hyperimmune product to protect volunteers against moderate to severe campylobacteriosis
• The second trial will focus on ETEC infections

MELBOURNE, Australia, June 19, 2020 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian biopharmaceutical company focused on developing and commercialising oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, today is pleased to provide shareholders with an update on the progress made to date on the company’s research collaboration with the Naval Medical Research Center (NMRC) previously announced in October 2019.

Immuron has now executed a research agreement with Australia’s national science agency, CSIRO. to produce the new therapeutic against Campylobacter and Entero-Toxigenic Escherichia coli (ETEC) for clinical evaluation by the US Department of Defense. Under the terms of the research agreement CSIRO has been engaged to produce a hyper-immune bovine colostrum product using vaccines developed by the NMRC. The work will be conducted at the Department of Agriculture and Water Resources Biosecurity Approved Arrangement facilities located in Armidale NSW.

“This is the second R&D program CSIRO has been engaged to undertaken recently with Immuron,” said CSIRO’s Dr Peter Hunt, principal research scientist.

“We are pleased to once again offer the services, expertise and facilities of CSIRO to produce this new therapeutic product for clinical assessment by the Naval Medical Research Center (NMRC). Approval was obtained from Biosecurity Australia early this year to import the NMRC vaccines and they have been in storage since the COVID-19 pandemic hit the world. I am pleased to report the vaccination campaign has been finally initiated and the finished product should be available by the end of this year.”

Immuron is also pleased to inform shareholders that the NMRC submitted the Pre-IND information package as planned on the 10^th of June 2020 and expects to receive written comments on the non-clinical information from the U.S. Food and Drug Administration (FDA) within 30-days regarding its planned investigational new drug application to treat moderate to severe campylobacteriosis and ETEC infections. The company has also recently fully executed the Research Subaward Agreement with The Henry M. Jackson Foundation for Advancement of Military Medicine Inc. the Pass-Through Entity managing the Federal Award.

Immuron CEO, Dr Jerry Kanellos commented.

“We are grateful that the CSIRO is such a strong supporter of the Australian Biotechnology Industry. The current program is now back on track and we will have the hyper-immune bovine colostrum harvested in September 2020. The drug substance and drug product will be manufactured by the end of this year and will be available for the clinical development program to prevent acute infectious diarrhea which the NMRC plans to initiate early next year.”

COMPANY CONTACT: 

Dr Jerry Kanellos, Ph.D.
Chief Executive Officer
Ph: +61 (0)3 9824 5254
info@immuron.com

FAQ

What research agreements has Immuron executed recently?

Immuron has executed research agreements with CSIRO and The Henry M. Jackson Foundation for Advancement of Military Medicine to develop therapeutics.

What clinical trials is Immuron planning for 2021?

Immuron plans to conduct two human phase II clinical trials in 2021, focusing on campylobacteriosis and ETEC infections.

When did NMRC submit the Pre-IND package to the FDA?

The NMRC submitted the Pre-IND information package to the FDA on June 10, 2020.

What pathogens does Immuron's research target?

Immuron's research targets Campylobacter and Entero-Toxigenic Escherichia coli (ETEC).

What is the expected outcome of the vaccination program initiated by Immuron?

The vaccination program aims to produce a hyper-immune bovine colostrum product for clinical evaluation by the NMRC.