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Vaxxit corporate slidedeck_3q18

Presentation of Vaxxit and TatImmune, a novel immunotheraoy for HIV/AIDS, with a focus on South Africa epidemic and impact of vaccination with TatImmune on the health of people with HIV and on public HIV care costs

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Vaxxit corporate slidedeck_3q18

  1. 1. Innovating HIV/AIDS Therapy VAXXIT S.r.l. Corporate Presentation (2Q18) with Africa in mind
  2. 2. People with HIV (PWH) in 2016 South Africa •  7.1 million PWH •  18.9% adult HIV prevalence •  270,000 new HIV infections •  110,000 AIDS deaths •  56% adults on antiretroviral therapy (ART) 2 of which in
  3. 3. Antiretroviral therapy (ART) Although saving millions of people from death, ART has serious shortfalls Different drugs used in ART regimens 3
  4. 4. Drug failures/drug resistance (≈6%-61%, worldwide) nullify about 50% of the economic resources used for ART US$ billions spent to treat 20 million PWH are going to waste Wasted resources will double in next few years with 40 million PWH on ART Shortfalls % of PWH 1.  No effect on the virus reservoirs 100% 2.  No effect on chronic immune activation 100% 3.  Low/no immune response in latecomers to ART ≈40% -50% 4.  Tolerability problems and non- adherence ≈30% -80% The shortfalls of antiretroviral therapy (ART) cost US$ billions in wasted economic resources 4
  5. 5. ART: no effect on the Virus Reservoirs As result, PWH live under a lifelong siege causing Immunodeficiency, a state of chronic activation/ inflammation and dysfunction of the immune system Killed HIV viruses are constantly replenished with fresh reserves from the virus reservoirs CELLULAR RESERVOIRS ANATOMICAL RESERVOIRS Dormant memory T cells in lymph nodes and blood Central nervous system Gastrointestinal tract Genital tract Macrophages and dendritic cells in various tissues (especially in lymph nodes, gut and central nervous system) 5
  6. 6. Immunodeficiency, the hallmark of AIDS, carries higher lifelong risks of death as result of: • Progression to clinical stage disease • Co-morbidities (CVD highest) • Co-infections (TB highest) ART: no effect on Immunodeficiency 6
  7. 7. Nearly 50% of PWH do not respond to ART because too sick at diagnosis (CD4 < 200 cells/ml) Widespread non-adherence is caused by tolerability problems and lifelong ART dosing ART: Poor response and Non-adherence 7 Drug failures, drug resistance Disease progression Hospitalization Death
  8. 8. TatImmune is a promising solution to ART shortfalls: TatImmune launches antibodies against HIV Tat, a powerful weapon of infection and destruction Anti-Tat antibodies fight alongside ART by: Boosting T, B, NK cells, immune system troops against the adult virus (HIV RNA) Attacking HIV reserves (HIV DNA reservoirs) HIV DNA reservoirs HIV adult virus ART 8
  9. 9. Full course of treatment •  3 injections, one month apart, once during life •  possible boost after 3-5 years (to be tested) Active ingredient •  30 µg of recombinant HIV-1 Tat protein Formulation •  No adjuvant; isotonic saline buffer with human serum albumin; dispensed in glass vials Storage & stability •  -80° C: 3 years; -20° C: 6 months; 4° C: 2 weeks •  Heat-stable formulation under planning Product characteristics: Tatlmmune is administered by injection 9
  10. 10. Code Study Country Volunteers P-001 Phase I Preventive (Tat) Italy 20 P-002 Phase I Preventive (Tat+Env) Italy 11 T-001 Phase I Therapeutic (Tat) Italy 27 T-002 Phase II Therapeutic (Tat) Italy 168 T-003 Phase II Therapeutic (Tat) South Africa 200 T-002 EF-UP Extended follow-up of T-002 Italy 92 T-003 EF-UP Extended follow-up of T-003 South Africa 179 Total Volunteers 426 Vaccinated Volunteers 314 Proven in Phase I and II studies Publications Ensoli B. et al. AIDS 2006, Ensoli B. et al. AIDS 2008, Ensoli B. et al. Vaccine 2009, Longo O. et al. Vaccine 2009, Bellino S. et al. Reviews on Recent Clinical Trials 2009,Luzi A.M. et al. AIDS Care 2011, Ensoli B et al. PLoS ONE 2010; Ensoli F. et al, Retrovirology 2015, Ensoli B et al., Retrovirology 2016 10
  11. 11. Both studies met clinical endpoints: Publications: Ensoli B et al, PLoS ONE 2010; Ensoli F et al, Retrovirology, 2015; Ensoli B et al, Retrovirology, 2016, manuscripts in preparation Two Phase II studies completed Immunogenicity and Efficacy (primary) and Safety (secondary) •  168 white volunteers on ART for 8+ years •  Randomized open label; reference group as control; 11 sites •  Follow-up study: 92 volunteers •  Completed in 4Q16 •  200 black volunteers on ART for over 3+ years •  Randomized placebo-controlled, 100 treated and 100 placebo, 1 site •  Follow-up study: 187 volunteers •  Completed in 4Q16 Italy (T-002) 8+ years South Africa (T-003) 3+ years 11
  12. 12. Efficacy results after 8+ years from vaccination Publications: Ensoli B et al, PLoS ONE 2010; Ensoli F et al, Retrovirology, 2015; manuscript in preparation on extended follow-up results Boost of the immune system Steep reduction of virus reservoirs Persistent increase of CD4+ T cells, highest in poor responders to ART (>200 cells/µl) Persistent and steep reduction; HIV DNA provirus undetectable in blood of 31 of 92 volunteers (34%) Italian phase II study 12
  13. 13. Nearly identical results to those of the Italian study Publications: Ensoli B et al., Retrovirology, 2016, manuscript in preparation on extended follow-up results South Africa Phase II Study Italy South Africa N=38 N=99 Highly immunogenic: ≈95% Effective against all major HIV subtypes ItalySouth Africa South Africa Italy 13
  14. 14. Clinical and economic benefits Reduction of HIV care costs Intensification of ART efficacy in chronically-treated PWH Improved (faster/better) response to ART in newly- treated PWH Reduction of immunodeficiency conditions Lower risks of co-morbidities and co-infections (primarily CVD and TB) Boost of the immune system Steep damage to HIV reserves Lower rates of drug failures, hospital visits and deaths 14
  15. 15. Strong support in South Africa 15 SA clinical trials’ Consortium (TV PPP-004): has pledged €8.2 million for phase III trials UNIDO (U.N. Industrial Development Organization): endorsement in Nov. 2015 South African Department of Health: endorsement in Nov. 2014 The Tat Vaccine Partnership: led by the SA Medical Research Council; soliciting support from donors for paediatric trials and supporting grant applications
  16. 16. Giovanni Cozzone, CEO Email: Skype ID: cozzone Vaxxit Srl Via dei Valeri 1, 00184, Rome, Italy Thank You Contact Information