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Immuron Limited (IMRN)

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Immuron Reports Neutralizing activity Against SARS-CoV-2

Key Points:

  ? Immuron’s IMM-124E used to manufacture Travelan® and Protectyn® demonstrates antiviral activity against the COVID-19 virus in laboratory studies
  ? Immuron’s technology platform offers a potential new oral therapeutic approach to target SARS-CoV-2 in the GI Tract

 

Melbourne, Australia, July 21, 2020: 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 announce that IMM-124E used to manufacture the company’s flag ship commercially available and over-the-counter gastrointestinal and digestive health immune supplements Travelan® and Protectyn® has demonstrated neutralizing activity against the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19.

The cytopathic effect inhibition cell-based assay was established and performed by 360 biolabs, a Melbourne based Contract Research Organization using the SARS-CoV-2 hCoV-19/Australia/VIC01/2020 virus obtained from Melbourne’s Peter Doherty Institute for Infection and Immunity. The in-vitro assessment of the neutralization of SARS-CoV-2 was performed on four production lots of product used to manufacture Travelan® and Protectyn®. The In-vitro susceptibility of the virus to IMM-124E was determined using the quantitative assay which measures virus replication in the presence of increasing concentrations of the product compared to replication in the absence of the product. The effective concentration of IMM-124E was reported as the concentration of the product at which virus replication is inhibited by 50 percent (EC50) or 90 percent (EC90).

All four production lots produced mean EC50 values of 40.5 to 91.9 ug/mL and inhibited viral replication at concentrations which there was no observed cell toxicity. The concentration of IMM-124E at which virus replication was inhibited by 90 percent (EC90) produced mean EC90 values ranging from 48.7 to 155.4 ug/mL for all four lots tested again at concentrations at which there was no observed cell toxicity. A commercially available high protein milk powder product was used as a placebo in the studies and produced EC50 values greater than the observed cellular cytotoxicity concentration of >4800 ug/mL. The control milk powder inhibited viral replication at doses >25,000 ug/mL and more importantly did not inhibit viral replication at doses which it was cytotoxic to cells.

Another major finding made during the study was that cell viability in the presence of IMM-124E was greatly enhanced when compared to placebo. IMM-124E improved cell viability by 180 to 260% relative to controls. These results indicate that IMM-124E at concentrations which inhibited SARS-CoV-2 replication improved cell viability.





US DoD Naval Medical Research Center Receives FDA Guidance on the clinical development plans for new oral therapeutic
July 20 2020 - 06:00AM
GlobeNewswire Inc.
Print

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, today is pleased to announce that the Naval Medical Research Center (NMRC) has received written guidance from the U.S. Food and Drug administration (FDA) in relation to the clinical development pathway of a new investigational drug which the company is developing to treat moderate to severe campylobacteriosis and Enterotoxigenic Escherichia coli (ETEC) infections.

The Type B meeting with the FDA discussed the Chemistry, Manufacturing and Controls including the proposed release testing specifications of the product as well as the planned clinical studies evaluating the safety and efficacy of the product which the company is developing to prevent Campylobacter and ETEC mediated moderate to severe diarrhea.

The FDA were recently provided a Pre- Investigational New Drug (IND) package for the new Hyper-immune therapeutic which specifically targets Campylobacter jejuni capsule and Enterotoxigenic Escherichia coli (ETEC) colonization factor antigen 1. Following FDA review the agency provided a written response to the non-clinical questions posed in the briefing documentation as well as providing additional guidance and comments to support the planned IND submission.

“This is an important milestone in the development of any new drug for therapeutic evaluation. The information obtained from this review will assist in the development of the IND application and provides a clear roadmap forward for conducting the two planned clinical studies next year,” said Dr. Jerry Kanellos, CEO of Immuron Ltd. “The company is also please to inform shareholders that the manufacturing program is proceeding as planned. We have completed the second immunisation campaign and are on schedule to harvest the Hyper-immune colostrum in September this year which will be used to manufacture the drug product that will be used to treat moderate to severe campylobacteriosis and ETEC infections.”

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

For more information visit: http://www.immuron.com

 

Primary Logo

www.immuron.com


Level 3, 62 Lygon Street,
Carlton South, Victoria
AUSTRALIA 3053

Phone: + 61 (0)3 9824 5254
Facsimile: + 61 (0)3 9822 7735




 

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PostSubject
#139   IMRNW$..bid/ask under $2? what a great lottery ticket imo... Pisd 08/24/20 10:39:35 AM
#138   5.5 M shares outstanding IMRN$$ ... Pisd 08/20/20 03:17:48 PM
#137   Waiting on update covid19 vaccine PILL, also progress Pisd 08/20/20 01:17:22 PM
#136   Considering getting more but need 1 or 2 Dubster watching 07/30/20 03:33:25 PM
#135   I love this stock I already made profits RealPainkiller 07/27/20 08:01:11 PM
#134   Not down from where I purchased shares. $11.45 at Dubster watching 07/27/20 07:14:53 PM
#133   It's down what are you talking about? RealPainkiller 07/27/20 06:27:56 PM
#132   Loaded some shares and slightly green. Looks like Dubster watching 07/27/20 02:53:31 PM
#131   Today need HUGE news every 3_days keep peeps attention-span... Pisd 07/27/20 02:40:21 PM
#130   IMRNW$ increase a dollar as does common $4-$5-$6 etc... Pisd 07/24/20 01:41:51 PM
#129   ...approximately seventy to eighty percent of your immune Pisd 07/24/20 12:41:11 PM
#128   Double's good?, still just getting started; COVID play.. IMRN$$... Pisd 07/24/20 10:22:12 AM
#127   This stock can't hold a gain for more RealPainkiller 07/23/20 04:17:30 PM
#126   Sold for a nice profit. Watching Dubster watching 07/23/20 01:55:21 PM
#125   idk, traded a little holding IMRN$..lot to like ... Pisd 07/22/20 09:18:21 AM
#124   * * $IMRN Video Chart 07-21-2020 * * ClayTrader 07/21/20 05:12:14 PM
#123   Yea it was nice then. Will be nice aidytrader 07/21/20 02:44:11 PM
#122   25.80 actually https://old.nasdaq.com/symbol/imrn/premarket RealPainkiller 07/21/20 02:36:56 PM
#121   If you sold pre-market it sure was. It RealPainkiller 07/21/20 02:35:57 PM
#120   Not looking as much a bargain now aidytrader 07/21/20 02:28:08 PM
#119   $20M shelf offering @ $18.75(ADS) Immuron Announces $20.0 Pisd 07/21/20 10:05:15 AM
#118   Maybe today?..Vaccine PILL for COVID19.. IMRN$, who'd a thunk?... Pisd 07/21/20 09:54:52 AM
#117   btw WARRANTS exchange for $10/share, bargain.. IMRN$ IMRNW$ ... Pisd 07/21/20 09:49:40 AM
#116   ORAL PILL vaccine LIKE VAXART killer..stay over $20 IMRN$$.... Pisd 07/21/20 09:16:13 AM
#115   HOLY F - A VIRUS STOCK NOW he-he-he-he IMRN$$... Pisd 07/21/20 07:42:40 AM
#114   Immuron Ltd. said Tuesday that a component called davidsson10 07/21/20 07:35:08 AM
#113   Immuron Reports Neutralizing Activity Against SARS-CoV-2 Key Points davidsson10 07/21/20 07:02:52 AM
#112   https://www.sec.gov/Archives/edgar/data/1660046/000121390020018030/ea124389ex99- davidsson10 07/21/20 06:49:16 AM
#111   Look at pre market! Wow! Over Barfly3718 07/21/20 04:43:43 AM
#110   * * $IMRN Video Chart 07-20-2020 * * ClayTrader 07/20/20 06:25:02 PM
#109   My bad..thought was great company FIRST cure for whatever... Pisd 07/20/20 04:56:44 PM
#108   Warrants $4+ behind IMRN share price atm IMRNW$ ... Pisd 07/20/20 01:05:53 PM
#107   Wow I may have to buy more... RealPainkiller 07/20/20 01:02:56 PM
#106   One thing people way underestimate IMRN$; swing trader only?... Pisd 07/20/20 01:01:53 PM
#105   Told you we had another pop coming.. could Rekaewt 07/20/20 01:01:22 PM
#104   4.4M shares trading 40M volume = low floater IMRN$.. Pisd 07/20/20 12:59:24 PM
#103   This is my favorite stock. It's basically a RealPainkiller 07/20/20 12:53:11 PM
#102   One more big pop after 2pm before close Rekaewt 07/20/20 12:49:50 PM
#101   It will but after 2pm or market close IMO Rekaewt 07/20/20 12:49:22 PM
#100   Nope it will go back down like it RealPainkiller 07/20/20 12:40:33 PM
#99   PPS +125%; warrants up $1..back up the truck IMRNW$.. Pisd 07/20/20 12:22:25 PM
#98   Target for today 35 $ Rekaewt 07/20/20 11:34:11 AM
#97   Nice. I've been holding this for awhile since RealPainkiller 07/20/20 11:14:05 AM
#96   btw warrants exercise for $10..presently $2.50..INRN$ $14... Pisd 07/20/20 11:13:47 AM
#95   Shorts caught off guard. Getting decimated Rekaewt 07/20/20 10:08:42 AM
#94   2M trading float. crudeoil24 07/20/20 10:07:32 AM
#93   Finally got in at 16.50 looking for a Rekaewt 07/20/20 10:05:57 AM
#92   So pissed slow ass broker didnt fill my buy Rekaewt 07/20/20 09:58:48 AM
#91   Two human phase II clinical trials to be crudeoil24 07/20/20 09:53:11 AM
#90   US DoD Naval Medical Research Center Receives FDA crudeoil24 07/20/20 07:37:28 AM
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