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$Immuron (IMRN.US)$ NMRC Reports Results for Campylobacter Controlled Human Infection Model Study
Melbourne, Australia, October 4, 2024: Immuron Limited (ASX: IMC; NASDAQ: IMRN), is an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases. Following discussion with the US Naval Medical Research Command (NMRC), today the Company can announce that the NMRC has completed the interim analysis for the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC).
The results of this clinical trial are unrelated to Travelan® and do not impact Immuron’s plans to hold an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) with a view to initiating Phase 3 clinical trial(s) of Travelan® in 2H 2025. Nor does this NMRC trial impact on Immuron’s commercialization strategy for Travelan®. This commercialization strategy also includes the results of the Uniformed Services University clinical study (n=866) of Travelan® which is 85% recruited with topline results anticipated in April 2025 (NCT04605783).
The details of the trial are available at clinicaltrials.gov/study/NCT06122870 . The trial was funded by the NMRC. Immuron’s involvement in the study was to produce a hyperimmune bovine colostrum product using the NMRC developed campylobacter/ETEC vaccine which was tested in a controlled human infection model study.
Campylobacter jejuni is among the most common causes of diarrheal disease worldwide. Relatively little is known regarding what constitutes protective immunity against Campylobacter and there is currently no licensed vaccine to prevent disease caused by C. jejuni. C. jejuni is considered an invasive enteric pathogen, but the molecular details of its pathogenesis remain difficult to interpret or understand largely due to the lack of reliable, non-primate animal models of disease. To address this unmet medical need, the NMRC developed a conjugated vaccine using the Campylobacter jejuni capsule crosslinked to the colonization factor antigen 1 (CFA/1) of Enterotoxigenic Escherichia coli (ETEC). These key antigenic targets are predicted to be protective against diarrhea induced by both pathogens. Immuron used the conjugated vaccine to produce a new hyperimmune anti-microbial for clinical evaluation by the NMRC. The NMRC confirmed that the conjugated vaccine produced a robust immunological response in cows and reported that the new Hyper-immune therapeutic contains high levels of antibodies which specifically target Campylobacter jejuni capsule and CFA/1 (ASX Announcement 9 November 2020).
Melbourne, Australia, October 4, 2024: Immuron Limited (ASX: IMC; NASDAQ: IMRN), is an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases. Following discussion with the US Naval Medical Research Command (NMRC), today the Company can announce that the NMRC has completed the interim analysis for the clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC).
The results of this clinical trial are unrelated to Travelan® and do not impact Immuron’s plans to hold an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) with a view to initiating Phase 3 clinical trial(s) of Travelan® in 2H 2025. Nor does this NMRC trial impact on Immuron’s commercialization strategy for Travelan®. This commercialization strategy also includes the results of the Uniformed Services University clinical study (n=866) of Travelan® which is 85% recruited with topline results anticipated in April 2025 (NCT04605783).
The details of the trial are available at clinicaltrials.gov/study/NCT06122870 . The trial was funded by the NMRC. Immuron’s involvement in the study was to produce a hyperimmune bovine colostrum product using the NMRC developed campylobacter/ETEC vaccine which was tested in a controlled human infection model study.
Campylobacter jejuni is among the most common causes of diarrheal disease worldwide. Relatively little is known regarding what constitutes protective immunity against Campylobacter and there is currently no licensed vaccine to prevent disease caused by C. jejuni. C. jejuni is considered an invasive enteric pathogen, but the molecular details of its pathogenesis remain difficult to interpret or understand largely due to the lack of reliable, non-primate animal models of disease. To address this unmet medical need, the NMRC developed a conjugated vaccine using the Campylobacter jejuni capsule crosslinked to the colonization factor antigen 1 (CFA/1) of Enterotoxigenic Escherichia coli (ETEC). These key antigenic targets are predicted to be protective against diarrhea induced by both pathogens. Immuron used the conjugated vaccine to produce a new hyperimmune anti-microbial for clinical evaluation by the NMRC. The NMRC confirmed that the conjugated vaccine produced a robust immunological response in cows and reported that the new Hyper-immune therapeutic contains high levels of antibodies which specifically target Campylobacter jejuni capsule and CFA/1 (ASX Announcement 9 November 2020).
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TheOracleOfHindSight : My God I want my 2 minutes back for reading that! So… buy low?
Trytosaveabit OP TheOracleOfHindSight : Hehehe! That’s only part of it! Hehehe
TheOracleOfHindSight : Dear lord- good thing we get up early!