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Immexis

Immexis. Developing tomorrow’s vaccines. Immexis. Company Background. Immexis is a spin-out company of the Royal Veterinary College Focused on unmet needs for effective therapeutic vaccines in treating persistent infectious diseases

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Immexis

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  1. Immexis Developing tomorrow’s vaccines

  2. Immexis Company Background • Immexis is a spin-out company of the Royal Veterinary College • Focused on unmet needs for effective therapeutic vaccines in treating persistent infectious diseases • Product pipeline to include products for hepatitis B, hepatitis C and HIV • Will bring benefit to healthcare providers and increase quality of life for patients • Will add value to novel drug delivery technology • Has secured a DTI SMART Award and potential for £250,000 from the Bloomsbury BioSeed Fund • Currently seeking £600,000 to complete preclinical work on lead product for treating hepatitis B

  3. Team and Roles • John Pool, Role: Director and Chairman Presently independent management consultant for Scottish Enterprise Formerly CEO, Proteus Molecular Design • Colin R. Howard, DSc PhD FRCPath FIBiol Role: Chief Scientific Officer Presently Professor of Microbiology and Vice-Principal for Research, RVC CEO of London BioScience Innovation Centre Ltd Previously Associate Director, Proteus Molecular Design PLC • Felicity D’Mello, PhD BSc Role: Senior Investigator and Lab Manager Presently Research Fellow, RVC • Linda Klavinskis, PhD BSc Role: Consultant and Chief Scientific Adviser Presently Senior Lecturer in Immunology, KCL Previously at Roche and Scripps Clinic, USA

  4. Immexis Medical Need and Market • In excess of 600 million people presently suffering long-term virus infections (hepatitis B, hepatitis C, HIV) • Current antiviral therapies give only short term improvement, require expensive monitoring, and may lead to drug-resistant strains • Increasing demand for vaccines against non-infectious chronic disease • Demyelinating diseases • Osteoporosis • Cancer • Allergies • Snake venom • Autoimmune disease

  5. Immexis The Value Proposition • Global vaccine market estimated at $5.5b with expected growth of 13.5% p.a. to in excess of $10bn by 20101 {40% North America, 36% Europe, Japan 2%, ROW 22%} • The market share for therapeutic vaccines will rise progressively over the next 3-5 yrs2 (hepatits B market to exceed $2b) • Cost of treating chronic hepatitis B is $700m p.a. in the USA alone, $10,000 per patient • Globally over 1.2 million new HBV infections per year, 200,000 in the USA • By 2010, 5 million people worldwide will require treatment • Estimated cost per dose of a therapeutic vaccine $5003 1 Frost and Sullivan 2 BCCI 3 Institute of Medicine, 2000

  6. Immexis Current Post-Exposure Therapy Exposure to virus through blood, body fluids, blood products Exposure to virus through blood, body fluids, blood products Treatment with antiviral drugs Debilitating long term disease Short-term Clinical improvement • Drawbacks • Not sustained • Replication-specific • Resistance develops • Viral DNA still present

  7. Immexis Exposure to virus through blood, body fluids, blood products Exposure to virus through blood, body fluids, blood products Treatment with antiviral drugs Debilitating long term disease Sustained Clinical improvement Immexis Development of novel therapeutic vaccines Post-exposure therapeutic vaccination The Immexis Concept of Post-Exposure Vaccination Transaminases to baseline Eliminate inflammation Reduce / eliminate levels of cccDNA Minimise fibrosis DNA

  8. Immexis Scientific Rationale • Current research suggests clearance of HBV from infected liver requires a vigorous stimulation of cellular immunity not induced by preventative vaccines • DNA injection stimulates cellular immunity (cytotoxic lymphocytes) mediated by MHC-type I antigen presentation But: • Responses require large doses and/or multiple injections • Despite encouraging results in mice, clinical trials of therapeutic DNA vaccines against flu and other diseases in humans have proved disappointing Our technology addresses these weaknesses

  9. Immexis Research and Development Platform HBV gene sequences coding for gene products Immediate stimulation of cell-mediated immunity to HBV proteins C and X Polymers designed to form nanospheres containing nucleic acids and/or proteins Sustained anti-preS/S antibody response to prevent virus spread Sustained stimulation of interferon gamma to promote virus clearance Delivery systems OctoPlus Test of potency in mice Examine efficacy in woodchucks Clinical trials in humans

  10. Immexis Research and Development Platform HBV gene sequences coding for gene products Immediate stimulation of cell-mediated immunity to HBV proteins C and X Polymers designed to form nanospheres containing nucleic acids and/or proteins Sustained anti-preS/S antibody response to prevent virus spread Sustained stimulation of interferon gamma to promote virus clearance Delivery systems OctoPlus Test of potency in mice OctoPlus polymer: Water-soluble Approved for human use Consistency of manufacture Examine efficacy in woodchucks Clinical trials in humans

  11. Immexis Financial Requirements • Pre-clinical research £650,000 • Management • Scientific Staff • Consumables and animal costs • Premises • Clinical phase £3 million • Phase I/IIa Clinical trials • Pre-clinical research for HIV/HCV • Funds obtained • SMART Award (DTI) £45,000 • BBSF (University challenge fund) £250,000 (must be matched)

  12. Immexis Key Data and the Opportunity The Immexis programme has several unique features that will enable the creation of an effective therapeutic vaccine: • Novel delivery systems developed for delivery of peptide and DNA immunogens - Microparticles of water-soluble polymers (in partnership with OctoPlus) • A series of unique DNA plasmids and peptides specific for HBV have been produced - Consensus sequences, expressing all structural proteins and X, a regulatory protein • Patient groups identified and baseline data available - Chronic hepatitis patients refractory to interferon and/or lamivudine treatment - Liver transplant patients • Patent applications on delivery system and new protein immunogens in preparation • Assessment of responses in animals, exploiting the RVC veterinary expertise and available know-how

  13. Immexis Customers • Merck • GSK • Chiron Vaccines • Gilead • RheinBiotech / Berna What keeps these people awake at night? • Patent expiries – need for new technologies • Platform technologies for products inducing cellular immunity • Competing in Asian markets driven by new technologies • Adjuncts needed for antiviral drugs specific for hepatitis

  14. Immexis How the Business will be built • Immexis has a pipeline agreement with the RVC for exclusive access to the vaccine technology • The focus will be on generating sufficient preclinical/clinical data to secure strategic partners • Risk will be minimised by adding value to IP acquired by in-licensing • Long term value will be created by application of Immexis know-how to develop vaccine products for treating other persistent viral diseases • Non-core products will be licensed out to the pharmaceutical/vaccine industries for taking forward into clinical trials

  15. Immexis Exit Strategy • Most likely through a trade sale or acquisition within 5 years • Major vaccine manufacturers looking for an enhancement in product pipeline to include therapeutic vaccines against diseases of economic importance • Vaccine market predicted to increase substantially • Licensing revenue in year 4, profitability in year 7 • Target valuation >$10m in 4-5 years • An IPO is possible with HBV and HCV products in clinical trials

  16. Immexis Competition

  17. Immexis Summary • Focused on clearly defined market needs for therapeutic vaccines against persistent virus infections • A strong value proposition • Innovative approach to immunogen design • Use of proven drug delivery technologies for vaccine development • Phase I / II trials cohort identified • First class technical and scientific team • Highly regarded business & scientific advisors

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