LAMP-based Vaccines. Revolutionary Technology to Treat Allergic Disease, Cancer, Infectious Disease

Transcription

1 LAMP-based Vaccines Revolutionary Technology to Treat Allergic Disease, Cancer, Infectious Disease Immunomic Therapeutics Update Presentation April 2014 For additional information, visit Hershey, PA Rockville, MD

2 Page 2 Corporate Information OVERVIEW

3 Applying Patented LAMP Technology to Next Generation Vaccines Already Applied in Multiple Clinical Trials Allergy: Successfully completed Phase IA and IB study of 24 subjects (17 in follow-on Ib) for cedar pollen allergy Cancer: Prostate, Leukemia, Melanoma and Glioblastoma Studies showed immune activation & safety Literature: Over 100 publications related to LAMP in the academic literature Page 3

4 LAMP-vax Produces Next Generation Results Treatments for diseases such as allergy Mitigation of disease for cancer, HIV, HPV Prevention beyond traditional vaccines for allergy, malaria, HPV LAMP-vax can address disease areas unavailable to conventional vaccines and antibody therapies Antibody therapies generate $60B in annual revenue Page 4

5 LAMP Technology - Vaccines Are Multi-Billion Dollar Markets The global human vaccine market is rapidly growing Global market >$25 billion in 2011 with >30% AGR Dominated by Big 5 Pharma companies The Allergy market is >$1.0B in 2010 for immunotherapeutics Allergy Market is >$11B for symptom therapy The Animal health vaccine sales were $4.0B in 2010 Fragmented market: companion & feedstock animals Growth driven by entry into new markets like cancer & allergy Page 5

6 Immunomix is Meeting Milestones & Goals ITI Has Achieved Significant Accomplishments Completed Phase IA & IB Clinical Study of JRC- LAMP-vax better than expected results We have achieved significant milestones already! Secured written indications of interest from 4 Japanese partners moving to next steps Peanut allergy vaccine nearly ready for Phase I clinical study Completed 3 commercial licenses supplementing our funding with non-dilutive capital Patent protection until at least 2024 Animal health deal with Lilly expected to generate ongoing revenue in 2014 & beyond Page 6

7 ITI Has Experienced, Dedicated Management Bill Hearl, Ph.D. CEO Bernard Rudnick CFO & Strategic Advisor Bruce Mackler, Ph.D., J.D. Regulatory Affairs Expert W. Barry McDonald Chairman Business Development Teri Heiland, PhD VP of R&D Serial Entrepreneur (2 nd Start up) Successful previous exit for Investors (10X return) Experienced biotech financier Founded, scaled, and successfully exited several startups (total exits $720 million) Highly experienced regulatory affairs consultant Broad industry FDA experience Experienced industry CEO (Hitachi-MAST) Worldwide connections in the allergy and healthcare industries 25 Years of Industry Experience in R&D Holder of Multiple Patents Vaccine & Mol. Biology Page 7

8 Page 8 The Disruptive Potential of LAMP A NEW ERA IN VACCINES

9 LAMP Technology: Value Proposition LAMP-vax Technology is the missing link that enhances the effectiveness of DNA vaccines. Has the ability to make DNA vaccines work Will reign in an era of simple, inexpensive and effective vaccinations for a wide spectrum of diseases. DNA and other nucleic acid vaccines have been in development since the 1990s Technologies such as LAMP that will make them a reality This class of vaccines is poised to revolutionize the vaccine industry and public health as a whole. Page 9

10 LAMP-Vax Competitive Advantages DNA Vaccines as a class present great versatility, safety and simplicity. LAMP-vax DNA technology improves immunogenicity of DNA vaccines low cost scalable solution Eliminates need for expensive and painful delivery systems such as electroporation eliminates the danger and unknowns of molecular adjuvants such as cytokines. LAMP s MHC-II Targeting Strategy Necessary for Clinical Relevancy Proven Safety in the Clinic Multiplexing Antigens Plug & Play Vaccine Design for Rapid Product Line Development. Page 10

11 LAMP - A New Paradigm in Allergy Treatment SCIT / SLIT Long course of therapy Complex mechanism of action, still not well understood Modest improvements in symptom scores Initially increases IgE LAMP-vax 8 week course of therapy Th1 specific presentation with immunological memory In mice, can prevent symptoms; in human converts skin test results Decreases IgE while increasing IgG LAMP-vax is Safe - patients are treated without exposure to any protein allergen Immunomic Therapeutics can treat families of allergy with a single formulation Mechanism is driven by Th1 mediated education of the immune system; there is no enhancement of the IgE response in allergic treated subjects Page 11

12 Human Health Pipeline - Internal & External Development Antigen Design Validation Preclinical Ph. I Ph. II Ph. III Commercial Partner / Academic Collab. Allergy Immunotherapy JRC-LAMP-vax (Jap. Red Cedar) Cry j2 Internal Development JCC-LAMP-vax (Global Cedar, Juniper, Cypress) CryJ1, j2, j3 Internal Development ARA-LAMP-vax (Peanut) Ara h1, 2, 3 Mt. Sinai Multi-LAMP-vax (Multivalent) Undisclosed Internal Development CAD-LAMP-vax (Canine AD) Undisclosed Undisclosed Oncology Immunotherapy GRNVAC1 (Prostate Cancer, AML) htert BioTime / Asterias GRNVAC2 (AML and Other) htert BioTime / Asterias TriMix DC Therapy (Melanoma) MAGE-A3 / C2 tyrosinase, gp100 U. Brussels Td+pp65 DC (Glioblastoma) pp65 Duke University TMZ + LAMP+ antigen mrna (Glioblastoma) Undisclosed University of Florida Infectious Disease Vaccines HIV-LAMP-vax Gag-pol-nef-tat-vif Internal Development HIV Clade B mrna DC Therapy Tat, rev, nef U. Brussels Page 12

13 Key Highlights of the Past Year Obtained positive results in Phase 1a and Phase 1b trials JRC skin test positive to negative conversion 100% A recently published 3,000 patient study showed over 80% correlation between skin test and symptoms Showed IgG increase and IgE reduction at 320 days Not seen in competitors trials Secured new license option with our large pharmaceutical Animal Health partner for canine allergy vaccine Page 13

14 Summary of Phase I Clinical Studies of JRC-LAMP-vax Efficacy & Safety Goals for JRC-LAMP-vax Phase 1a Results Phase 1B EFFICACY: Elimination of JRC/Mtn C/CryJ2 skin test reactivity 14 of 16 subjects 100% conversion Conversion skin test from positive to negative 15 of 16 subjects 100% conversion Increase in antigen specific IgG responses SAFETY: No anaphylactic / allergic responses (CryJ2 sequestered intracellular no leakage) Achieved Achieved Maintained No anti LAMP antibody generation Achieved Maintained No severe adverse reactions Achieved Maintained Skin test negative patients remain negative 8 of 8 subjects Maintained IgE levels stable or decreasing Achieved Achieved Page 14

15 ITI is in Discussion with Interested Pharma in Japan for Collaboration and Licensing on JRC-LAMP-Vax Other Major Pharma Companies are Acquiring Technologies and Companies to Fill their Pipelines Our Partnering Structure In Discussion will include upfront and milestone payments comparable to other deals done in this space highlighted below: Licensor Licensee Product Name Total Payment Upfront fee Millions ALK-Abello Merck Grazax, Mitizax $255 $35 ALK-Abello Torii Pharmaceuticals Alutard, Cedar Pollen extracts, dust mite $82.3 $41.1 King Pharmaceuticals Page 15 JHP Pharmaceuticals Full Product Line Acquisition Stallergenes Shionogi & Co. House dust mite, cedar pollen extracts $93 $90.2 $59.3 Maxygen ALK-Abello Maxy20, Maxy320 $80

16 What Comes Next and When? Continued development of allergy vaccines in 2014 with Phase II clinical study for JRC-LAMP-Vax Plan to initiate/file IND on peanut allergy vaccine in late 2014 Continued development of animal health product in collaboration with pharmaceutical partner Expanding relationships with academic collaborators for applications for LAMP in oncology Page 16

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