Immuron 聘請顧問為口服抗體藥 IMM-529 尋求合作，潛在年收入上看 4 億美元

EX-99.1
2
ea029707401ex99-1.htm
IMM-529 CDI PARTNERING UPDATE

 

Exhibit 99.1

 

 

Immuron Advances IMM-529 (Clostridioides difficile infection)
Partnering Strategy

 

Key Points

 

●Immuron Engages Pullan Consulting to Advance IMM-529 Partnering Strategy

   

 

●Immuron is seeking a partner to support clinical development through regulatory
approval and commercialization

   

 

●Immuron has U.S. Food and Drug administration (FDA) approval for IMM-529
Investigational New Drug (IND) application

   

 

●IND 32095 is Immuron’s Investigational
new drug (IND) application for clinical development of IMM-529 as a product to specifically prevent or treat Clostridioides difficile
infection (CDI)

 

Melbourne, Australia, July 6, 2026: Immuron Limited
(ASX: IMC; NASDAQ: IMRN) is pleased to announce that it has engaged Pullan Consulting to provide business development services to assist
in securing a strategic partnership for IMM-529.

 

Pullan Consulting is a highly regarded life sciences
advisory firm with a strong track record of executing between five and twelve partnering transactions annually over the past 20 years.
The firm specializes in guiding biotechnology and pharmaceutical companies through the partnering process, from strategy development and
partner identification to negotiation and transaction execution. Pullan Consulting’s expertise is expected to support Immuron in maximizing
the value of IMM-529 while advancing the program toward commercialization.

 

Immuron has U.S. Food and Drug administration
(FDA) approval for IMM-529 Investigational New Drug (IND) application (IND 32095) for clinical development of IMM-529 as a product to
specifically prevent or treat Clostridioides difficile infection (CDI) in a Phase 2 clinical trial.

 

IMM-529 has a validated biological target. FDA-approved
monoclonal antibody Bezlotoxumab was developed as a first-in-class therapy designed to prevent recurrence of Clostridioides difficile
infection (CDI) by neutralizing toxin B, the major driver of recurrent disease. IMM-529’s polyclonal antibodies offer multivalent
defense compared with monoclonal single-epitope antibodies (Bezlotoxumab). IMM-529 also has an advantage over current standard of care
antibiotic treatments that disrupt microbiota. IMM-529 decolonizes the gut facilitating clearance of the pathogen, recovery of the microbiome
and prevention of recurrent infection.

 

Immuron has completed an Investigational Brochure
and clinical protocol and has secured a principal investigator and three Australian sites. This trial is eligible for Australia’s
Clinical Trial Notification (CTN) scheme, a fast-track method for initiating trials.1 Immuron has manufactured and released
drug product for supply of a clinical trial.

 

The trial protocol is for a randomized, double
blind, placebo-controlled clinical study of IMM-529 with Standard of Care (SOC) for the treatment of CDI in subjects with first episode
CDI or recurrent CDI. Up to 60 subjects will be enrolled in the study. Subjects would be randomly assigned to IMM-529 + SOC or placebo
+ SOC in a 2:1 ratio at multiple sites. The primary objective would be to evaluate the safety and tolerability of IMM-529 together with
SOC in patients with CDI or recurrent CDI. Determination of efficacy would be assessed by the measurement and comparison of mortality
rate, disease symptoms and recurrence rate for each treatment group.

 

 

  

  

 

 

 

Opportunity assessment by Lumanity
indicates that if efficacious, IMM-529 will be positioned as early in treatment algorithm as payers will allow. It is anticipated that
first-episode and recurrent patients will be recruited in the IMM-529 Phase 2 clinical trial design. Up to ~98k patients would be eligible
if IMM-529 is positioned at the first recurrence. Based on the estimated market size, anticipated payer restrictions, pricing, and competition,
base case yearly revenue for IMM-529 is projected at US$400M. Oral dosing of IMM-529 was viewed as a positive by infectious disease experts.

 

The Company is seeking partners to advance clinical
development of IMM-529. Under a licensing model, the licensee typically funds development, registration, and commercialization costs.
Common licensing agreements include upfront fees upon execution of the document, as well as developmental milestone payments and royalties
on product sales. Terms from select historical CDI-focused deals that show a range of possible transaction structures are shown below.
With upfront payments ranging from USD$1-$50 million, milestone payments ranging from USD$25-$570 million, and typical royalties on sales
in the mid-to-high single digit percentage range, a successful development partnership for its IMM-529 asset could prove transformational
for Immuron.

 

 
 Year
 Licensor
 / Asset Owner
 Licensee
 / Acquirer
 Licensed
 Asset
 Financial
 terms (public)
 Stage
 at deal
 Status

 
 2023
 Destiny Pharma
 Sebela Pharmaceuticals
 NTCD-M3 (nontoxigenic C. difficile strain, live biotherapeutic)
 Upfront $1M; up to $570M milestones (incl. $19M development and up to $550M sales) plus royalties. (FT Markets)
 Phase 3 ready
 Phase 3 preparation continues, including work on a more patient friendly capsule formulation and regulatory alignment on Phase 3 design. (AMR Bio)

 
 2017
 Summit Therapeutics
 Eurofarma
 Ridinilazole (small molecule antibiotic)
 $2.5M upfront; up to $25M milestones plus royalties. (BioSpace)
 Phase 2/3
 Phase 3 program did not meet superiority vs vancomycin; Summit later focused its strategy on oncology (ivonescimab). (Fierce Biotech)

 
 2017
 Assembly Biosciences
 Allergan (later AbbVie)
 Microbiome GI programs (often cited as ABI-M201, ABI-M301; not CDI specific)
 $50M upfront plus milestones and royalties (per deal announcement coverage). (BioSpace)
 Preclinical
 Partnership was later unwound and the microbiome candidates returned; Assembly ultimately exited microbiome work. Note: public deal descriptions emphasize UC and Crohn’s, not CDI. (Fierce Biotech)

 
 

The increased incidence of antibiotic resistant
‘superbugs’ has amplified the use of broad-spectrum antibiotics worldwide. An unintended consequence of antimicrobial treatment
is disruption of the gastrointestinal microbiota, resulting in susceptibility to opportunistic pathogens, such as Clostridioides difficile
(C. diff). Paradoxically, treatment of Clostridioides difficile infection (CDI) also involves antibiotic use, and the heavy
reliance on antibiotics to control C. diff does not allow for the gut flora to regenerate and predisposes the patient to relapsing CDI.
C. diff is currently the most common pathogen in healthcare-associated infections and was deemed an urgent threat in the Center for Disease
Control and Prevention’s report on antibiotic resistance threats in the United States (CDC, 2019). CDI affects over 400,000 people
in the US on a yearly basis, contributing to over 30,000 deaths in the US alone annually. This serious health threat has led to an urgent
call for the development of new therapeutics to reduce or replace the use of antibiotics to treat bacterial infections.

 

 

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Immuron collaborated with Dr. Dena Lyras and her
team at Monash University, Australia to develop vaccines to produce bovine colostrum-derived antibodies. Dairy cows were immunised to
generate hyperimmune bovine colostrum (HBC) that contains antibodies targeting three essential C. diff virulence components. IMM-529 targets
Toxin B (TcB), the spores, and the surface layer proteins of the vegetative cells (refer to MOA schematic - below).

 

This unique 3-target approach has yielded promising
results in pre-clinical infection and relapse models, including (1) Prevention of primary disease (80% P =0.0052); (2) Protection
of disease recurrence (67%, P <0.01) and (3) Treatment of primary disease (78.6%, P<0.0001; TcB HBC). Importantly IMM-529
antibodies cross-react with whole cell lysates of many different human strains of C. diff including hypervirulent strains.

 

To our knowledge, IMM-529 is, to date, the only
investigational drug that has shown therapeutic potential in all three phases of the disease. https://doi.org/10.1038/s41598-017-03982-5

 

 

This release has been authorized by the directors
of Immuron Limited.

 

- - - END - - -

 

 

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 COMPANY
 CONTACT:
 PULLAN
 CONSULTING CONTACT:

 
  
  

 
 Steven Lydeamore
 Kristine Dorward

 
 Chief Executive
 Officer
 https://pullanconsulting.com/

 
 [email protected]
 [email protected]

 

About Immuron

 

Immuron Limited (ASX:
IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal
antibodies for the treatment of infectious diseases.

 

Immuron Platform Technology

 

Immuron’s proprietary
technology is based on polyclonal immunoglobulins (IgG) derived from engineered hyper-immune bovine colostrum. Immuron has the capability
of producing highly specific immunoglobulins to any enteric pathogen and our products are orally active. Bovine IgG can withstand the
acidic environment of the stomach and is resistant to proteolysis by the digestive enzymes found in the Gastrointestinal (GI) tract. Bovine
IgG also possesses this unique ability to remain active in the human GI tract delivering its full benefits directly to the bacteria found
there. The underlying nature of Immuron’s platform technology enables the development of medicines across a large range of infectious
diseases. The platform can be used to block viruses or bacteria at mucosal surfaces such as the Gastrointestinal tract and neutralize
the toxins they produce.

 

References

 

1. The Clinical Trial
Notification (CTN) pathway is Australia’s primary, fast-track method for initiating trials with unapproved therapeutic goods. It
involves HREC ethics approval and institutional governance review, followed by an online notification to the TGA (4-8 week process), rather
than direct regulatory review, facilitating rapid start-up.

 

Hutton, M.L., Cunningham,
B.A., Mackin, K.E. et al. Bovine antibodies targeting primary and recurrent Clostridium difficile disease are a potent antibiotic alternative.
Sci Rep 7, 3665 (2017). https://doi.org/10.1038/s41598-017-03982-5

 

For more information
visit: https://www.immuron.com.au/

Subscribe to Immuron’s
InvestorHub: Here

 

FORWARD-LOOKING STATEMENTS:

 

This press release may contain “forward-looking
statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934,
each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development
programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations
and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock
value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth
strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the
results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties
relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key
personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and
intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation
or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in
our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.

 

 

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