Immune Pharma
 Targeted Medicine




Immune Pharmaceuticals Corporation

Developing the Next Generation Monoclonal Antibod...
Immune Pharma A Development Stage Monoclonal Antibody Company
  Targeted Medicine


IMMUNE Pharmaceuticals is a New York b...
Immune Pharma Investing in a MAbs company is highly attractive
     Targeted Medicine




1.   Large and Growing Market
  ...
Immune Pharma A Portfolio with multiple shots on goal for $ 1 B drugs
      Targeted Medicine


.

 Multiple value creati...
Immune Pharma
Targeted Medicine




Beyond TNFalpha inhibitors
The first highly specific MAb for Rheumatoid Arthritis

IN ...
Immune Pharma Significant Unmet Medical Need
     Targeted Medicine   for new Rheumatoid Arthritis Treatment


   Only 30...
Immune Pharma First in Class CD44vRA MAb
    Targeted Medicine   Highly Specific for Rheumatoid Arthritis

               ...
Immune Pharma CD44vRA MAb binds to Gal-8
   Targeted Medicine           and induces Apoptosis of Inflammatory Synovial Cel...
Immune Pharma CD44vRA MAb equal or better than
            Targeted Medicine                        anti-TNFalpha in Ex Vi...
Immune Pharma Attractive Target Product Profile
  Targeted Medicine   for First in Class Anti-Human CD44vRA MAb


        ...
Immune Pharma
Targeted Medicine




Targeting Cancer Stem Cells
 with Fully Human Antibodies (cellular engineering)
Immune Pharma Treatment of cancer stem cells
  Targeted Medicine                  one step towards the cure*




         ...
Immune Pharma First in Class Anti-CD44 MAb
Targeted Medicine   targeting Cancer Stem Cells
                               ...
Immune Pharma IMPH Novel “Fully Human” MAbs
     Targeted Medicine        Initial application for anti CD44 MAbs in AML

 ...
Immune Pharma
Targeted Medicine




Bi-specific Antibodies
Enhanced Targeted Efficacy against Hematological and Solid Tumo...
Immune Pharma
     Targeted Medicine
                         Developing three novel Bi-Specific MAbs approaches



1.    ...
Immune Pharma                   IMPH to develop bi-specific anti-ErbB/ HER2
Targeted Medicine               antibodies in ...
Immune Pharma          R&D Investments supported
       Targeted Medicine      by strong Intellectual Property


   Exclu...
Immune Pharma IMPH Academic and Industry Network
  Targeted Medicine    generates a Pipeline of Opportunities


 IMPH Man...
Immune Pharma
    Targeted Medicine           A Strong Management Team


   Daniel Teper, PharmD, MBA, Chief Executive Of...
Immune Pharma IMMUNE aims to deliver Multiple Value Creating
Targeted Medicine   Milestones over the next 3 years




    ...
Immune Pharma
Targeted Medicine   Contact Details


                    Daniel Teper
                    CEO
             ...
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Transcript of "Immune pharma presentationapril2010"

  1. 1. Immune Pharma Targeted Medicine Immune Pharmaceuticals Corporation Developing the Next Generation Monoclonal Antibody Therapeutics Corporate Presentation April 2010
  2. 2. Immune Pharma A Development Stage Monoclonal Antibody Company Targeted Medicine IMMUNE Pharmaceuticals is a New York based biopharmaceutical company focused on First-in-Class Therapeutics addressing significant unmet medical needs in Oncology, Immunology and Infectious Diseases. IMMUNE is building a portfolio of Clinical and Pre-Clinical MAbs with multiple shots on goal for $ 1 billion drugs based on novel targets and proprietary best in class antibody technologies. IMMUNE is establishing a Research Center in Israel to capitalize on its academic relationships with Weizmann Institute and Hebrew University.
  3. 3. Immune Pharma Investing in a MAbs company is highly attractive Targeted Medicine 1. Large and Growing Market  Monoclonal Antibody Market $ 40 B in 2009 to reach $ 60 B by 2014  5 of top 10 drugs are MAbs and 8 have already reached $ 1 B in sales 2. Higher Development Success Rate  50% higher success rate with MAbs compared to small molecules (Tufts CSDD)  Faster clinical development and regulatory review ( IND to BLA in 6years) 3. Longer Commercial exclusivity with reduced Generic Threats  US Healthcare Law provides for at least 12 Years Marketing Exclusivity  Antibody Complexity and lack of Regulatory consensus to delay Biosimilars 4. Improved Engineering and Decreasing Manufacturing Costs  Novel Antibody Engineering delivers improved performance  Manufacturing Costs have decreased 50% in the last 10 years 5. Rich Partnering Opportunities Partnering for innovative phase 2 MAb exceeds $ 500 M per deal value 6. Higher Market and M&A Exit Valuations  Many company valuations range from $ 500 M to $ 2+ B
  4. 4. Immune Pharma A Portfolio with multiple shots on goal for $ 1 B drugs Targeted Medicine .  Multiple value creating milestones in next 3 years: 1. First-in Class Highly Specific Rheumatoid Arthritis MAb to reach phase II a ready for Corporate Partnering 2. In Licensed MAb for orphan indication to progress to phase II/ III 3. Two INDs for novel MAbs 4. Three MAbs promoted to Early Development Candidates ( pre-clinical POC) 5. Validated Fully Human and Bi-Specific Antibody technology platforms
  5. 5. Immune Pharma Targeted Medicine Beyond TNFalpha inhibitors The first highly specific MAb for Rheumatoid Arthritis IN PARTNERSHIP WITH
  6. 6. Immune Pharma Significant Unmet Medical Need Targeted Medicine for new Rheumatoid Arthritis Treatment  Only 30% of Rheumatoid Arthritis (RA) patients are treated with TNF-alpha blockers (Enbrel $8B, Remicade $6.9B, Humira $ 5.5B) 1. Unspecific immuno-suppression is responsible for severe and occasionally lethal infections, including Tuberculosis, 2. 2/3 of treated patients have Partial Response with TNF-alpha Blockers and still experience daily pain, stiffness and fatigue 3. 25-40% patients do not respond to TNF-apha blockers even at the lowest efficacy level (ACR 20) 4. 20% of patients experience diminishing response with TNF-alpha blockers over the course of the first year High Unmet Medical Need for a Highly Specific RA treatment with improved efficacy and limited off target safety concerns
  7. 7. Immune Pharma First in Class CD44vRA MAb Targeted Medicine Highly Specific for Rheumatoid Arthritis  CD44vRA MAb recognizes and targets specific protein expressed on the surface of pathological inflammatory cells but not expressed on normal cells, so healthy cells remain undamaged:  RA Specific: binds to 75% of synovial fluid cells from RA patients, Site of  Target Selective: not active in action  Peripheral white blood cells from of anti hCD44vRA the same patients, MAb  Keratinocytes from normal donors,  Synovial fluid cells from osteoarthritis patients Golan, Naor & all, Journal of Autoimmunity vol 28 issue 2-3 March-May 2007, Pages 99-113
  8. 8. Immune Pharma CD44vRA MAb binds to Gal-8 Targeted Medicine and induces Apoptosis of Inflammatory Synovial Cells The involvement of CD44 and its novel ligand Galectin-8 in the regulation of Auto-Immune Inflammation Golan, Naor & all, J.Immunol. 2007;179;1225-1235
  9. 9. Immune Pharma CD44vRA MAb equal or better than Targeted Medicine anti-TNFalpha in Ex Vivo and In Vivo models  Proof of Concept studies in Collagen Induced Arthritis standard In Vivo model  Histo-pathology shows: – Reduction in cell inflammation – Reduction in fibro-vascular proliferatiion – Reduction in cartilage destruction and improved repair  Anti-Human CD44vRA MAb 2.9 Negative Control F8:33 200 ug induces resistance to Collagen 2.7 F8:33 Tim e 200 ug F8:33 70 ug induces Arthritis in DBA/1 mouse anti-TNF 2.5 model because of the homology between mouse CD44 v4/v5 and Paw (mm) 2.3 2.1 human CD44vRA  1.9 Confirms ex vivo apoptotic 1.7 activity of inflammatory synovial 1.5 1 2 3 4 5 6 7 cells from RA patients Days
  10. 10. Immune Pharma Attractive Target Product Profile Targeted Medicine for First in Class Anti-Human CD44vRA MAb Anti-Human Anti-TNFalpha Oral CD44vRA MAb MAb Kinase Inhibitor Selectivity High Average Average Non specific immunosuppression Low Moderate to High Moderate to High Risk of severe infections and TB Risk of High Blood No No Yes Pressure Treatment Responders > 75% 50% 60% (ACR 20) up to 100% in CD44vRA positive patients Biomarker for Yes No No responders
  11. 11. Immune Pharma Targeted Medicine Targeting Cancer Stem Cells with Fully Human Antibodies (cellular engineering)
  12. 12. Immune Pharma Treatment of cancer stem cells Targeted Medicine one step towards the cure* 1. Next paradigm in cancer treatment 2. Significant data published and acknowledged 3. Cancer stem cells resist current treatments 4. Cancer stem cells lead to relapsing cancer 5. Targeted therapeutics of cancer stem cells can lead to full cancer cure *According to the American Society of Clinical Oncology, Journal of Clinical Oncology, June 2008
  13. 13. Immune Pharma First in Class Anti-CD44 MAb Targeted Medicine targeting Cancer Stem Cells 1. IMP 111 is a novel Anti-CD44 MAb with the following activity:  Targets specific epitope on constant part of CD44 on AML cells,  Survival benefit in knock out mice grafted with human leukemia cells  No hemagglutination 2. Antibody Dependant Cellular Phagocytosis (ADCP) is a novel mechanism of action demonstrated with IMP-111 3. Follow on screening of CD44 variant targets specific to Stem Cells in various malignancies and development of a library of fully human antibodies
  14. 14. Immune Pharma IMPH Novel “Fully Human” MAbs Targeted Medicine Initial application for anti CD44 MAbs in AML A Cellular Engineering Approach Human Lymphoma B Cells + Human Cord Blood Mouse Myeloma Cells Sorting CD34+ sorted cells Transplant Hetero-Myeloma Selected Antigen + Fusion Human Hybridomas Spleen extraction Mouse with human immune system Splenocytes Fully Human MAbs 14
  15. 15. Immune Pharma Targeted Medicine Bi-specific Antibodies Enhanced Targeted Efficacy against Hematological and Solid Tumors
  16. 16. Immune Pharma Targeted Medicine Developing three novel Bi-Specific MAbs approaches 1. Quadrivalent bi-specific antibodies • 3 Year EC financed pan-European academic research coordinated by IMPH co-founder • Patent License from CNRS-France 2. Bi-Specific Immuno-NanoParticules • Scientific collaboration between IMPH co-founder and Hebrew University (Prof. Benita) • One or two antibodies grafted on a NanoParticule • Ability to co-deliver a chemotherapeutic • Patent License from Yissum-Hebrew University 3. Dual Soluble Receptor Fusion Protein • Developed by IMPH
  17. 17. Immune Pharma IMPH to develop bi-specific anti-ErbB/ HER2 Targeted Medicine antibodies in partnership with Weizmann Institute Combinations of two anti-ErbB antibodies targeting different epitopes may increase therapeutic efficacy through enhanced endocytosis Synergistic Tumor Inhibition by anti-HER2 Antibody combinations T. Ben-Kasus, Bilha Schechter, Yossi Yarden & Michael Sela, Weizmann Institute ,of Science Publication in Proceedings of National Academy of Sciences, March 2009
  18. 18. Immune Pharma R&D Investments supported Targeted Medicine by strong Intellectual Property  Exclusive worldwide license from Maimonidex -Yissum/ Hebrew University Patents on CD44vRA  Patents filed by IMPH for CD44 target and antibody against Leukemia Stem Cells  Patents filed by IMPH on Fully Human Antibodies (Cellular Engineering)  Option to exclusive license from Weizmann Institute on HER2 combinations  Option to exclusive license from Feinstein Institute on CLL targets  Option to exclusive license on Quadrivalent Bi-Specific Antibodies from European Academic Consortium  Option to license on ImmunoNanoParticules from Yissum-Hebrew University
  19. 19. Immune Pharma IMPH Academic and Industry Network Targeted Medicine generates a Pipeline of Opportunities  IMPH Management has extensive global relationships with leading Academic Institutions and with Bio-Pharmaceutical companies, creating opportunities for rewarding partnerships such as: 1. In licensing or co-development opportunity of First-in-class novel anti- angiogenic target and antibody for the treatment of Age-Related Macular Degeneration 2. Development of Bi-Specific Antibodies against Specific targets in Chronic Lymphocytic Leukemia ( Collaboration with Prof. Nick Chiorazzi- Feinstein Institute-New York) 3. Development of Antibodies and Novel Delivery forms against anti- infective targets (Collaboration with Professor Pothier- France) 4. Development of MAbs against specific novel targets for a mid-size Biotech company
  20. 20. Immune Pharma Targeted Medicine A Strong Management Team  Daniel Teper, PharmD, MBA, Chief Executive Officer and Co-founder Dr Teper has been a Partner at Strategy Consulting firms, ISO Healthcare (now part of Monitor), Bionest , and 21 West, advising leading pharma and biotech companies. He has previously held sales, marketing, new product development and general management positions at Novartis, GSK, Sanofi-Aventis. Daniel holds an MBA from INSEAD and a Doctor of Pharmacy (PharmD) degree.  J.E. Kadouche, PhD, Co-founder, President and Chief Scientific Officer Dr Kadouche has 25 years experience in the development of MAbs in both Academia and Industry. He was until recently the CEO of MAT an Antibody company where he built and partnered a clinical and pre-clinical portfolio. He is the founder of Clonatec and was an advisor to Sangstat, Roche, Merck AG and J&J. He holds PhD in Immunology from the Pasteur Institute and was an Assistant Professor at St Louis Hospital.  John Mohr, CPA, Chief Financial Officer and Chief Business Officer Mr Mohr is a seasoned Business Development executive with over 20 years industry experience. He was until recently the SVP, Business Development at CV Therapeutics which was acquired by Gilead for $ 1.4 billion. As President of Fournier USA, he partnered with Abbott and launched Tricor, now a $1 billion drug. John is a CPA and started his career in Finance at Merck & Co..  Mitchell Glass, MD, Senior Vice President, Chief Medical Officer Dr. Glass brings leadership experience in drug development at GSK and AstraZeneca as well as emerging Biotech companies and Academia. Mitchell is strong relationships with the FDA and the NIH. received his MD from the University of Chicago and is a member of the American Thoracic Society and American Academy of Asthma, Allergy & Immunology.  Eli Eldan, MBA, Vice-President, General Manager, Israel Operations
  21. 21. Immune Pharma IMMUNE aims to deliver Multiple Value Creating Targeted Medicine Milestones over the next 3 years 2011 2012 2013 First In Class RA MAb Phase I Phase II In Licensed Orphan MAb Phase I Phase II INDs Novel MAbs Early Dev. Candidates Antibody Technology Platform Partnering
  22. 22. Immune Pharma Targeted Medicine Contact Details Daniel Teper CEO Email: d.teper@immunepharma.com Jean Kadouche President, Research Email: j.kadouche@immunepharma.com 22
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