Immuron Limited · ASX:IMC
Immuron — Shareholder Meeting (November 2009)
43 slides from Immuron's shareholder meeting presentation, Nov 27, 2009
Slide 1: Immuron Presentation to Annual General Meeting by Professor Yaron Ilan
ASX Release 27 November 2009 For personal use only Immuron Limited Presentation to Annual General Meeting by ABN 80 063 114 045 Medical Director of Immuron Limited Professor Yaron Ilan Corporate Details: ASX Code: IMC Attached is the presentation given at the Immuron Annual OTCQX Code: IMROY (U.S.)
Slide 2: Oral Immunotherapy
For personal use only Oral Immunotherapy Yaron Ilan, M.D. Department of Medicine Hebrew University-Hadassah Medical Center Jerusalem, Israel November 2009 Confidential 1
Slide 3: Disclosure
Disclosure For personal use only • I am not in a posi+on to discuss any commercial issues or chances of success. • I will discuss data related to the scien+fic studies performed at Hadassah. • As with any new product there is uncertainty as to the poten+al of success and no guarantee can be given. 2
Slide 4: Oral Immunotherapy
Oral Immunotherapy For personal use only • An attractive approach to treat autoimmune, infectious, malignant and inflammatory diseases. • An active process that uses the inherent ability of the GI tract's immune system to control unwanted systemic immune responses, by inducing regulatory T cells in
Slide 5: Oral Immunotherapy
Oral Immunotherapy For personal use only • Not associated with general immune suppression • No side effects or toxicity • No risks of severe infection or malignancy • Easily tolerated by patients • Platform for a wide range of diseases • Oral administration, painless • Low cost • Rapid development c
Slide 6: The immune system of the bowel
The immune system of the bowel • The gut mucosal immune system is the largest lymphoid organ. For personal use only • It differentiates the antigenic signals against the high background noise of food and bacterial antigens. • Despite constant antigenic stimulation, suppression of inflammation is the
Slide 7: Regulatory lymphocytes
Regulatory lymphocytes For personal use only • Main controllers of the immune response in inflammatory, infectious and malignant disorders. • Regulatory T cells are defective in many infectious, inflammatory and malignant disorders in humans • No current therapy can correct this defect. • Oral admin
Slide 8: Colostrum is the first milk produced by lactating mammals
Colostrum is the first milk produced by lactating mammals For personal use only • Colostrum contains – Immunoglobulins: Represent the mother’s exposure. – Non-immunoglobulin adjuvants that affect cell functions: • Lactoferrin • Alarmins • Glycolipids • Growth factors • Syntenin-1 The role of dietary
Slide 9: Oral administration of colostrum-derived antibodies
Oral administration of colostrum-derived antibodies For personal use only Oral passive and active immunity Naturally-occurring proteins Derived from colostrum of cows vaccinated with disease-specific antigens One platform across all indications Same safe risk profile Feeding of antibodie
Slide 10: The metabolic syndrome
The metabolic syndrome For personal use only • Diabetes type 2 • Fatty liver disease • Atherosclerosis • Hyperlipidemia
Slide 11: Type II Diabetes
Type II Diabetes For personal use only • Affects 9% of the western world’s population. • Is the fifth leading cause of death. • The biomedical industry is focused on metabolic disease as it represents one of the greatest areas of unmet need in medicine. • The potential market for monitoring and trea
Slide 12: Non-Alcoholic Steatohepatitis (NASH)
Non-Alcoholic Steatohepatitis (NASH) For personal use only • The most common liver disease in the western world. • Associated with obesity, diabetes, hyperlipidemia. • Affects 5% of the lean population, 20% of the obese population, and 50% of morbidly obese people. • The total U.S. market potential
Slide 13: Oral anti-CD3 suppresses EAE in a dose-dependent fashion
Oral anti-CD3 suppresses EAE given prior to EAE induction in a dose-dependent fashion For personal use only Indirect immune fluorescence 0 0.5 hr 1 hr 3 hr Oral IV iv 3hr Ochi, Nature Medicine, 2006
Slide 14: β-Glucosylceramide
For personal use only GC β-Glucosylceramide
Slide 15: Leptin deficient ObOb mice
Leptin deficient ObOb mice For personal use only • Features the metabolic syndrome: Non-alcoholic steatohepatitis, diabetes, obesity, hyperlipidemia.
Slide 16: GC decreases serum triglyceride and transaminase levels
GC decreases serum triglyceride levels GC decreases serum transaminase levels For personal use only * IU * * GC improves glucose tolerance test Lalazar, Am. J. Pathol., 2009
Slide 17: GC decreases hepatic fat accumulation
GC decreases hepatic fat accumulation For personal use only Control Ob/Ob GC-treated Ob/Ob * Control GC-treated Ob/Ob Ob/Ob Margalit, J. Exp. Therap. 2006
Slide 18: Oral GC suppresses hepatocellular carcinoma
Oral GC suppresses hepatocellular carcinoma For personal use only * Tumor growth * GC Survival (%) Tumor volume (mm3) Zigmond, Gut, 2007
Slide 19: Suppression of malignant melanoma by GC
Suppression of malignant melanoma by GC For personal use only Control GC Tumor weight Apoptotic cells * *
Slide 20: The combination of antibody + adjuvant is synergistic
The combination of antibody + adjuvant is synergisitc For personal use only * * * * * *
Slide 21: For personal use only
Passive For personal use only Immunity (Topical) using bovine an+bodies Address major medical Ac+ve immunity targets (Cellular) triggered by oral bioac+ves 20
Slide 22: For personal use only
For personal use only Passive Immunity (Topical) using bovine an+bodies Active naturally-derived and safe Address oral immunotherapy major medical Ac+ve immunity targets (Cellular) triggered by oral bioac+ves 21
Slide 23: Target organs
Target organs • Pancreas For personal use only • Adipose tissue Disease-specific antibody • Liver + • Brain Colostrum adjuvants Presented in the bowel Induction of regulatory cells
Slide 24: Colostrum with anti-insulin antibodies corrects diabetes in mice
Colostrum enriched with anti-insulin antibodies corrects diabetes in mice For personal use only Following 4 weeks of oral therapy
Slide 25: Anti-insulin colostrum alleviates insulin resistance in mice
Colostrum enriched with anti-insulin antibodies alleviates insulin resistance in mice For personal use only Following 4 weeks of oral therapy
Slide 26: Anti-insulin colostrum alleviates liver damage in mice with NASH
Colostrum enriched with anti-insulin antibodies alleviates liver damage in mice with NASH For personal use only Following 4 weeks of oral therapy
Slide 27: Anti-insulin colostrum decreases serum lipids in mice
Colostrum enriched with anti-insulin antibodies decrease serum lipids in mice with hyperlipidemia For personal use only Following 4 weeks of oral therapy
Slide 28: Anti-insulin colostrum decreases liver fat in mice
Colostrum enriched with anti-insulin antibodies decrease the fat in the liver in mice For personal use only Following 4 weeks of oral therapy
Slide 29: Proposed mechanism
Proposed mechanism For personal use only • Colostrum enriched with anti-insulin antibodies acts in three major sites : The liver The adipose tissue BC BC – Bovine The colostrum gut
Slide 30: Preliminary results
Preliminary results For personal use only • The use of colostrum enriched with an+ influenza an+bodies • The use of colostrum enriched with an+ hepa++s B virus an+bodies 29
Slide 31: Oral anti-influenza colostrum antibodies with adjuvants improve immune response
Oral administration of colostrum derived anti-influenza antibodies with adjuvnats improve the anti-influenza immune response For personal use only Oral antibody + colostrum derived adjuvants Passive immunity Active immunity Decrease of suppressor cells Augment of anti-influenza cellular immunity Adv
Slide 32: Anti-influenza colostrum increases cellular immunity
Colostrum enriched with anti influenza antibodies increase the anti influenza cellular immunity For personal use only
Slide 33: Anti-influenza colostrum decreases suppressor cells
Colostrum enriched with anti influenza antibodies decrease suppressor cells For personal use only CD4 CD25 CD4+CD25+ CD4+Foxp3+ A1 15.58 0.58 0.54 2.69 A2 15.2 0.47 0.42 1.96 A3 21.23 1.05 0.98 3.31 A4 19.49 1.06 1.02 1.7 AVG 17.88 0.79 0.74 2.42 STDev 2.96 0.31 0.30 0.73 B1 3.88 0.54 0.44 0.48 B2 2
Slide 34: Anti-hepatitis colostrum suppresses liver cancer growth in mice
Colostrum enriched with anti heaptitis antibodies suppresses the growth of liver cancer in mice For personal use only Control Treated 10 µg Treated 1 µg
Slide 35: Phase I clinical trial
For personal use only Phase I clinical trial Oral administration of OKT3+GC Healthy male volunteers (3 per group) were orally administered mouse anti-human OKT3 at three doses: 0.2, 1.0, 5.0 mg/feeding. Feeding 0 1 2 3 4 5 6 7 8 9 10 30 Days Blood drawing Ilan Y. J Clin Immunology, 2009
Slide 36: Effect of oral OKT3 on IgG repertoire
Effect of oral OKT3 on IgG repertoire Pt 1 Pt 2 Pt 3 For personal use only 0 5 10 30 0 5 10 30 0 5 10 30 Complement C3 Smith antigen PPD MMP3 Glutamine Synthetase LIF Neurofilament 200 kDa 5.0 T. gondii p30 4.0 HCV core antigen S. minnesota LPS 3.0 H. pylori lysate 2.5 Ribonuclease 2.0 IL-13 HSP60 a
Slide 37: The effect of an adjuvant
The effect of an adjuvant Healthy volunteers were orally administered 7.5 mg of GC alone or For personal use only in combination with 0.2 mg or 1.0 mg OKT3. Oral OKT3 with GC increases CD4+FoxP3+ OKT3 OKT3+GC 0 5 10
Slide 38: Safety and Effect of Oral Administration of EGS21 in NASH
Safety and Effect of Oral Administration of β-D-glucosylceramide (EGS21) in Subjects with Non-Alcoholic Steatohepatitis For personal use only Study No. 04-815.R1 Protocol No. 815-01-0506 Study design: Double-blind, placebo-controlled Treatment regimen – every day Treatment duration – 40 weeks Dose:
Slide 39: Effect of oral administration of β-glucosylceramide
Effect of oral administration of β-glucosylceramide Primary endpoint - HbA1c Secondary endpoint - % Fat by MRI For personal use only Effect of GC on NASH in humans Patient No. 905 Week 0 Week 40
Slide 40: Status of Clinical Trials
Status of Clinical Trials For personal use only Disease Status Estimated time Expected to start results Type 2 diabetes IRB 1/2010 5/2010 and fatty liver Influenza IRB 2/2010 5/2010 HCV Approved
Slide 41: Future applications
Future applications Cancer • Melanoma For personal use only • Hepatocellular carcinoma • Leukemia Infections • HIV • Anthrax • HBV, HCV • Clostridium Immune disorders • Rheumatoid arthritis • Multiple Sclerosis Degenerative diseases • Alzheimer’s disease
Slide 42: Summary
Summary For personal use only Orally-delivered natural antibodies with adjuvants derived from hyper-immune colostrum Established clinical record and safety profile Broad market opportunities Low manufacturing costs Not associated with immune suppression No side effects or toxicity Easi
Slide 43: Thank you
For personal use only Thank you