V Rifor Slide Share April2010


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V Rifor Slide Share April2010

  1. 1. Vaccine Research International Plc Vaccine SA75 for MRSA NON-CONFIDENTIAL SlideShare April 2010
  2. 2. VRi Vaccine SA75 <ul><li>VRi’s low-cost vaccine SA75 </li></ul><ul><li>in clinical development </li></ul><ul><li>aims at the </li></ul><ul><li>£10 billion spent globally </li></ul><ul><li>on hospital acquired infections. </li></ul>
  3. 3. VRi History <ul><li>2002 Company established </li></ul><ul><li>Objective - Creation of new Staph aureus vaccine for world markets </li></ul><ul><li>First Project – SA75 </li></ul><ul><ul><li>Whole-cell vaccine produced from chloroform-inactivated Staph. aureus cells - derived from clinical isolate </li></ul></ul><ul><ul><li>Cross-reactivity with global MRSA strains </li></ul></ul><ul><ul><li>Simple and low-cost manufacturing process </li></ul></ul><ul><li>2004 Raised a total of £2.4 milllion for Phase I Clinical Trial of SA75 </li></ul><ul><li>2006 Phase I Clinical Trial of SA75 successfully completed in UK </li></ul><ul><li>2007/08 Lab-based R&D and planning on Proof of Concept. </li></ul><ul><li>2009 £0.75m raised in UK to recommence Manufacturing and R&D programmes. </li></ul><ul><li>2010 Global patent filing commenced in major vaccines markets. </li></ul>
  4. 4. VRi’s Whole-Cell Vaccine approach <ul><li>Staph infection very complex and multi-stage process </li></ul><ul><ul><li>Establishment & Replication </li></ul></ul><ul><ul><li>Production of significant number of different toxins </li></ul></ul><ul><ul><li>Varying degrees of pathogenicity </li></ul></ul><ul><li>VRi believe whole-cell Staph vaccine will provide better protection and cross-reactivity than component vaccines. </li></ul><ul><li>Failure of Nabi’s StaphVax component vaccine in Phase III </li></ul><ul><ul><li>Despite good preclinical package and early clinical data </li></ul></ul><ul><ul><li>Nabi failed to protect end-stage renal dialysis patients in PIII </li></ul></ul><ul><li>GSK component vaccine project now replaced with buy-out of Nabi Pentavax for $50m. </li></ul>
  5. 5. VRi SA75 Vaccine <ul><li>Whole cell vaccine produced from chloroform-inactivated Staph. aureus cells </li></ul><ul><ul><ul><li>derived from clinical isolate (strain P/DFO 75) </li></ul></ul></ul><ul><li>Cross reactivity with MRSA strains </li></ul><ul><li>Immunogenic response in rabbits and man </li></ul><ul><ul><ul><li>no requirement for adjuvant </li></ul></ul></ul><ul><li>Well tolerated in Phase I clinical study in male volunteers </li></ul><ul><li>Simple and low cost manufacturing process </li></ul>
  6. 6. VRi SA75 Vaccine: Toxicology <ul><li>Single dose – rabbit (n=10); subcutaneous – 3.09mg/ml + adjuvant </li></ul><ul><ul><ul><li>Local inflammatory response </li></ul></ul></ul><ul><ul><ul><li>No clinical signs of toxicity </li></ul></ul></ul><ul><li>Local tolerance – rabbit ; subcutaneous and intramuscular (n=3) – 3.09mg/ml + adjuvant </li></ul><ul><ul><ul><li>Local inflammatory response </li></ul></ul></ul><ul><ul><ul><li>No clinical signs of toxicity </li></ul></ul></ul><ul><li>Repeat dose – rabbit (n=36); subcutaneous – 0.7mg/ml and 3.09mg/ml ± adjuvant . Four injections administered at 2 weekly intervals. </li></ul><ul><ul><ul><li>Local inflammatory response at both doses – more pronounced in presence of adjuvant </li></ul></ul></ul><ul><ul><ul><li>Dose and time-dependent IgG immune response </li></ul></ul></ul><ul><li>AMES test </li></ul><ul><ul><ul><li>Non-mutagenic </li></ul></ul></ul>
  7. 7. VRi SA75 Vaccine: Phase I Clinical Trial <ul><li>Placebo controlled double blind </li></ul><ul><li>48 healthy male volunteers </li></ul><ul><li>3 dose groups (12 test; 4 placebo per group) </li></ul><ul><ul><ul><li>0.15mg per dose </li></ul></ul></ul><ul><ul><ul><li>0.36mg per dose </li></ul></ul></ul><ul><ul><ul><li>0.45mg per dose </li></ul></ul></ul><ul><ul><ul><li>4 vaccinations given subcutaneously (0.5ml) at 2 week intervals </li></ul></ul></ul><ul><li>Primary objectives </li></ul><ul><ul><ul><li>Safety </li></ul></ul></ul><ul><ul><ul><li>Tolerability </li></ul></ul></ul><ul><li>Secondary objectives </li></ul><ul><ul><ul><li>Evaluation of antibody response (immunoblot and ELISA) </li></ul></ul></ul><ul><ul><ul><li>Persistence of antibodies at 3 months and 6 months after the last injection </li></ul></ul></ul>
  8. 8. Phase I Clinical Trial - Monitoring <ul><li>Safety - Local and systemic signs </li></ul><ul><ul><ul><li>0hr, 4hrs and 8 hrs on day of vaccination (day 1) and days 2, 3 and 8 </li></ul></ul></ul><ul><ul><ul><li>Erythema,induration,bruising, pain (Local) </li></ul></ul></ul><ul><ul><ul><li>ECG, blood pressure, temperature, haematology, biochemistry </li></ul></ul></ul><ul><li>Immune response </li></ul><ul><ul><ul><li>Blood samples taken before and after each vaccination </li></ul></ul></ul><ul><ul><ul><li>Immunoblotting and ELISA against homologous vaccine preparation </li></ul></ul></ul><ul><ul><ul><li>ELISA against four binding proteins </li></ul></ul></ul><ul><ul><ul><ul><li>collagen binding protein </li></ul></ul></ul></ul><ul><ul><ul><ul><li>fibronectin binding protein </li></ul></ul></ul></ul><ul><ul><ul><ul><li>fibrinogen binding protein </li></ul></ul></ul></ul><ul><ul><ul><ul><li>extracellular adherence protein </li></ul></ul></ul></ul>
  9. 9. Phase I - IgG Immunoblotting Reaction 12/12 0/12 0/12 0.45 9/12 2/12 0/12 0.36 6/12 6/12 0/12 0.15 0/12 5/12 7/12 Placebo Strong Weak None Vaccine Dose (mg)
  10. 10. Longevity of immune response <ul><li>(Secondary study objective – Non-GLP testing) </li></ul><ul><li>Serum from 32* volunteers taken 3 and 6 months after 4th vaccination – comparison with reactivity at 2 weeks following 4th (final) vaccination: </li></ul><ul><li>Group 1 Group 2 Group 3 </li></ul><ul><li>(0.15mg) (0.45mg) (0.36mg) </li></ul><ul><li>Vaccinated Subjects </li></ul><ul><li>Above pre immune 11/11 11/11 10/10** </li></ul><ul><li>level at 3 and 6 months </li></ul><ul><li>Placebo </li></ul><ul><li>No change in reactivity 4/4 4/4 4/4 </li></ul><ul><li>at 3 and 6 months </li></ul><ul><li>* Volunteers lost to follow up 007, 020, 036 and 044. </li></ul><ul><li>** Volunteer 047 (Group 3) who did not have a sample at 6 months </li></ul>
  11. 11. Next steps for VRi <ul><li>Seeking further investment to finance and extend collaborations on R&D, Manufacturing and Market Commercialisation of SA75 </li></ul><ul><li>£3m required to underpin R&D. </li></ul><ul><li>We are open to various exits and formats but prefer to out-licence the SA75 project to a single global industry partner </li></ul><ul><li>We understand the due diligence process and are fully open to deep disclosure and data swapping </li></ul>
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