Immunimed Inc.

An Innovative, clinical stage Biopharmaceuticle company, developing Oral Dose Therapeutic Antibodies to treat C Difficile Infection

SEEKING FUNDING AND COLLABORATIONS

ImmuniMed Inc., is a clinical-stage Canadian Biopharmaceutical Company focused on developing novel Oral Dose Therapeutic Antibodies for unmet medical needs.

Our innovative technology produces antibodies targeting specific pathogens like Clostridioides Difficile bacteria.

Development of our novel Oral Dose Antibody Therapy:

Conventional vaccination stimulates the recipient host immune system to produce antibodies in the host to prevent future infections. In contrast, ImmuniMed’s novel approach is to orally deliver ready-made target specific antibodies directly to the host to inhibit or combat disease. Furthermore, as the antibodies are produced in chicken eggs, a component of the daily human diet, the treatment is considered GRAS (Generally Recognized As Safe) by the U. S. Food and Drug Administration (FDA).

Clinical Development:

ImmuniMed Inc is recruiting patients in Calgary and Winnipeg with mild-moderate Clostridioides difficile infections for a Phase II clinical study to determine the optimal dosage and clinical efficacy of egg derived antibodies, IM-01, (ClinicalTrials.gov NCT04121169).

The safety and effectiveness of Immunimed Inc’s Oral Dose Therapeutic Antibody treatment has been demonstrated in clinical studies performed in Canada, the USA and Australia, under compassionate grounds. Four Gastroenterologists and one Infectious Disease Specialist treated 106 Clostridium difficile - infected patients with oral antibody therapeutic IM-01, and showed positive clinical response. More than 94% of CDI patients treated with IM-01 showed dramatic improvement in clinical response and negative stool test results were measured. Furthermore, no relapse of the disease was reported during a 6-week follow-up period.

Demonstrating effectiveness of Oral Dose Therapeutic Antibodies:

1. In Animal Agriculture:
Our oral antibodies are used in animal agriculture for prevention of diarrhea and improvement of growth performance in pigs and calves by targeting Enterotoxigegic E. coli (US patent # 7713527). We received regulatory approval from the Canadian Center for Veterinary Biologics and were granted an Establishment License for manufacturing of antibody-vaccine, as well as a Product License for marketing as a Veterinary Biologic – a first in the world.

2. Research project titled: Development of Safe and Effective Immunotherapy for Childhood Cryptosporidiosis. We demonstrated the effectiveness of orally-administered antibodies targeted to Cryptosporidium parvum, which significantly reduced the disease burden, parasite-load and improved the survival time in a C. parvum – infected disease mice model. (Manuscript is in preparation).

Intellectual Property:

1. Use of Polyclonal Antibodies Against Clostridium difficile for Treatment of Inflammatory Bowel Disease. US Patent # 10513552 B2
2. Polyclonal antibodies Against Clostridium difficile and Uses Thereof : US patent # 9873732
3. Polyclonal antibodies Against Clostridium difficile and Uses Thereof : European Patent # EP 2957570
4. Polyclonal antibodies Against Clostridium difficile and Uses Thereof: Canadian Patent # CA 289517

Strategic Advantages:
ImmuniMed’s innovative antibody therapy has many strategic and competitive advantages over other therapies:

• Safety
1. Proven safe with animal and human studies.
2. Chicken egg derived antibodies are safe for human consumption and recommended in a healthy diet.
3. Egg-derived antibody products are considered GRAS (Generally Recognized As Safe) by the FDA.

• Efficacy
1. Proven efficacy in animals to treat gastro-enteric illnesses.
2. Shown clinical efficacy in patients with CDI in previously completed compassionate studies.

• Scalability
1. Established large-scale production for Egg-derived therapeutic antibodies.

ImmuniMed Inc. Team:

• Dr. Pradip Maiti, M.Sc., Ph D. is an accomplished researcher and business manager with over 40 years of experience in the fields of Microbiology and Immunology, from both Academia and the BioPharmaceutical industries, with expertise in the development and commercialization of antibody based therapeutics. Dr. Maiti holds over 20 patents in the Antibody Therapy field.

• John Hare, MBA, is a Winnipeg entrepreneur with over 35 years of experience starting and leading businesses in the livestock nutrition and biotech industries.

For more information please contact John Hare, phone: 204-955-8495, email: john@hareman.com