1. Innovating HIV/AIDS Therapy
VAXXIT S.r.l.
Corporate Presentation (2Q18)
with Africa in mind

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. Antiretroviral therapy (ART)
Although saving millions of people from death,
ART has serious shortfalls
Different drugs used in ART regimens
3

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Giovanni Cozzone, CEO
it.linkedin.com/in/giovannicozzone/
Email: ceo@vaxxit.com
Skype ID: cozzone
Vaxxit Srl
Via dei Valeri 1, 00184, Rome, Italy
Thank You
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