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1. GeoVax Labs, Inc. October 14, 2011 Greater Rome Chamber of Commerce 2011 Technology Symposium O11_IRG
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3. SOURCE: 2009 Report on the Global AIDS Epidemic, UNAIDS/WHO (December 2009) Total Living with HIV: 33.4M Total Clade B: 3.5M New Infections: 2.7M New Clade B:185,400 HIV/AIDS โ A Continuing Global Challenge O11_IRG / North America 1.4 M 55,000 NEW Caribbean 240,000 20,000 NEW Latin America Clade B 900,000 76,500 NEW Western/Central Europe 850,000 30,000 NEW Middle East / North Africa 310,000 35,000 NEW Sub-Saharan Africa 22.4M 1.9 M NEW Eastern Europe/ Central Asia 1.5 M 110,000 NEW South/Southeast Asia 3.8 M 280,000 NEW Oceania 59,000 3,900 NEW East Asia 850,000 75,000 NEW Latin America Other 900,000 93,500 NEW B B B B C C C
4. SOURCE: CDC Fact Sheet โ Estimates of New HIV Infections in the United States (August 2008) Current Rate of New Infection:55,000-58,000 per year * Estimated Cost for Each U.S. Infection = $500,000 (Aggregate, $27.5 billion/year) * AIDS 2010 Annual Meeting (Atlanta GA) Estimates for New HIV Infections in US O11_IRG / 0 1979 1983 1987 1989 1993 1997 2001 2005 20,000 40,000 60,000 80,000 100,000 120,000 140,000
5. Impact of a Preventative AIDS Vaccine A 50% effective vaccine given to just 30% of the population could cut the 33 million projected number of new HIV infections in the developing world by more than half over 15 years. SOURCE: AIDS Vaccine Blueprint 2006, IAVI Report NOTE: Polio Vaccine is 60-70% effective / Flu Vaccine 70-90% effective O11_XTRA / NO VACCINE Vaccine Introduction 4.0 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0.0 2010 2015 2020 2025 2030 30% Efficacy 20% Coverage 50% Efficacy 30% Coverage 70% Efficacy 40% Coverage Total New Infections Averted by an AIDS Vaccine between 2015 - 2030 5.5 Million 17 Million 28 Million
6. Total Annual Global Revenue* Projections for 1 st Generation AIDS Vaccines * Only Preventative Vaccine Revenue Reported; Therapeutic Market Estimated at $3.6B US/$3.6B ROW SOURCE: IAVI, October 2007 HIV/AIDS Preventative Vaccine Market O11_IRG / SCENARIO HIGH OPTIMISTIC BASELINE BASELINE LOW Peak Global Revenue $5.5B $4.8B $4.5B $2.5B Avg. Annual Sales Revenue (over years 0-30) $4.3B $3.2B $2.6B $1.4B Cumulative Sales Revenue over 30 year period $134.4B $98.4B $81.7B $43.8B 6 5 4 3 2 1 0 0 5 10 15 20 25 30 Years since FDA/EMEA regulatory approval
13. Phase 1 Human Trial โ Government Supported Published by The Journal of Infectious Diseases Challenge Dose 30-300 Times Higher Than Typical Human Dose DNA Vaccine with GM-CSF Adjuvant (Primate Data) O11_IRG / 0 80 100 60 40 20 Number of Challenges 0 2 4 6 8 12 10 Percent Uninfected 70% Prevention of Infection 5 / 7 No Evidence of Infection โ To Date >12 Months 100% Infection Controls (0 / 15 Protected)
19. Rate of Vaccine Responses * Responding T cells, intracellular cytokine staining ** Anti-Env binding AB, ELISA *** After 6 intrarectal challenges with a dose 40-400 times higher than typical human dose NOTE: Polio Vaccine is 60-70% effective / Flu Vaccine 70-90% effective O11_XTRA /
20. Current Status: Therapeutic AIDS Vaccines O11_XTRA / Vaccine Sponsor Antibody (Ab to Env) T Cell Comments Bavarian Nordic MVA/BN Multiantigen NO YES Phase 1 Completed CD4 & CD8 T cells Bionor Immuno Vacc-4x Peptides NO YES Phase 2 Completed CD4 T cells but limited Response Rates Inovio PENNVAXโข-B (pDNA) Unknown YES Phase 1 Active U Penn vaccine, CD4 & CD8 T cells Profectus BioSciences Multiantigen DNA + rVSV Unknown Unknown 2010 Start Planned ACTG Study GSK gp120+nef/tat fusion proteins & adjuvant YES YES Phase 1 Completed Low level neutralizing Ab, CD4 T cells Argos Therapeutics AGS-004 (RNA transfect DC) NO YES Phase 2b Active Personalized medicine approach GEOVAX DNA / MVA YES * YES * Phase 1 Enrolling * Data from GV Phase 1 trial in HIV Uninfected
21. Current Status: Preventative AIDS Vaccines Out of more than 80 vaccines entering HVTN Phase 1 testing, GeoVax Vaccines represent 2 of 6 to progress to Phase 2 O11_XTRA / Vaccine Sponsor Antibody (Ab to Env) T Cell Comments VaxGen gp 120 YES NO FAILED gp120, atypical Env Merck Ad5 NO YES FAILED Ad5 seropositive participants at higher risk NIH / VRC DNA Ad5 YES YES ENROLLING Limited to Ad5 seronegative, circumcised Not intended as commercial product Aventis ALVAC / gp120 YES LOW TRIAL COMPLETE Prevention of infection in 31% of Participants GEOVAX DNA / MVA YES YES PHASE 2a Enrollment Complete GEOVAX MVA / MVA YES YES PHASE 2a Addendum Enrollment Started December 2010