TechnoVax is developing novel Virus-Like Particle (VLP) vaccines using a cell-based manufacturing system that is safer, more effective, and scalable compared to traditional egg-based vaccine production. Their VLP technology is being used to develop vaccines for influenza, respiratory syncytial virus (RSV), and other diseases. Their influenza VLP vaccines include seasonal tetravalent and "universal" versions. They are seeking partnerships to advance their preclinical vaccine candidates into clinical trials.

1. VLPs
A Vaccine Platform for the future!
Innovative Technologies for
Respiratory Vaccines
Influenza Congress 2012
Washington, DC, November 2012
Hector Munoz – Corp. Dev.

2. Welcome to TechnoVax
• TechnoVax is a biotechnology company based in Tarrytown - Westchester
County (New York) that specializes in Viral Vaccine Development.

3. Creating a New Generation of Vaccines
• Company mission is to create and advance towards
commercialization vaccines that are:
– Safe
– most effective
– novel
• To achieve our mission, TechnoVax seeks:
– strategic cooperations and partnerships to support vaccine
programs and advance candidates toward the market.

4. Dynamic Team, Big Ideas!
TechnoVax functions as a semi-virtual biotech company. The core team is composed of 9 full
time employees with advanced degrees in their respective fields of specialty (virology,
molecular biology, microbiology, immunology and vaccine R&D).
The company is also supported
by external collaborators from
well known institutions such as
Baylor College of Medicine, New
York Medical College and CUNY
(City University of New York).
Dr. Jose Galarza is the Pioneer of the influenza Virus-
Like Particle (VLP) Vaccine Technology.

5. What We Do
• Our unique and innovative VLP technology is
used to develop and produce vaccines for infectious
diseases such as:
 influenza,
 respiratory syncytial virus (RSV),
 para-influenza virus (PIV) and
 other diseases including Dengue, HIV and cancer.

6. TechnoVax’s VLP Technology
TechnoVax and its team of scientists have developed a new way to produce highly
immunogenic, non-infectious monovalent and polyvalent virus-like particle (VLP)
vaccines using a cell-based manufacturing system.
Influenza virus Influenza Virus Like Particle (VLP)
Resembles the virus but lacks nucleic acid and ability to replicate!

7. Production of Flu VLP Vaccines – 2 methods:
Baculovirus Vector Continuous Cell Line System
Advantages:
• Rapid and Flexible Cell Culture Manufacturing Systems.
• Platform technology suitable for multiple vaccine development.
• Highly immunogenic vaccines eliciting robust immune responses. Safe product without the need for
inactivation
• High yield, larger production capabilities, shorter production time and lower cost.
• Creation of Master Cell Banks (Cont. Cell Line Sys.).

8. Rapid and Scalable Manufacturing System
Current “Egg” Process VLP Technology
Virus grown in embryonated chicken eggs VLP are produced in a cell culture system
• Safety Concerns: • VLPs are Non-Infectious:
• Killed vaccine requires chemical inactivation
• Live attenuated vaccine requires extensive safety • No inactivation required
evaluation • Reduced safety concerns during production.
• Toxic viruses (i.e. 1918, H5) kill the embryo and
prevent vaccine production
• Not adequate for pandemic response • Rapid Response to emerging pandemic or
epidemic influenza virus strains due to fast and
flexible system.
TVX full 1st Wave -
TVx 1st production production Pandemic Egg-based 1st Egg-based full
batch pandemic batch production
Infected Cases Vaccine Supply
Egg-based
TVx
0 1 2 3 4 5 6 7 8 9 10 Months

9. Reduced Manufacturing Costs & Capex
Egg-Based Plant Cell-Culture Plant VLP Plant
A fully functional manufacturing plant producing 20 million doses of VLP vaccine annually,
will require an investment (CAPEX) of:
$50 million > $75 million < $10 million
Manufacturing cost (1 dose) Manufacturing cost (1 dose) Manufacturing cost (1 dose

10. Working on a Strong Pipeline for the Future
Flu Vaccines:
TechnoVax is planning to file for an
IND for its lead Seasonal Flu
vaccine in 2013 and human clinical
trials targeted for the end of 2013.
However “Inhaled Powder” version
might replace it
An “Universal” Flu vaccine is in
development and currently in animal
pre-clinical testing.
RSV Vaccine:
Is developing rapidly on an
accelerated path for animal testing at
Baylor College of med. sponsored by
the NIH with a target goal to file for
IND in H1-2013.
Dengue Vaccine:
Is developing rapidly and on an
accelerated path for preclinical
testing to take place in 2013.

11. “Seasonal Tetravalent” Influenza VLP Vaccine
The tetravalent flu VLP
vaccine incorporates an
additional B antigen to
those recommended by
WHO, thus broadening
vaccine protection.
Advantages:
• Reduced manufacturing
steps, time and costs.
• Protects against multiple
influenza virus strains.
• Increased efficiency by targeting
multiple viruses.

12. “Self-Inhaled Powderized” Influenza VLP Vaccine
TechnoVax and MannKind Corp. have combined their respective
technologies to create a Powder Formulation of VLP Influenza
Vaccine for Intrapulmonary Self-Delivery by Inhalation.
Flu VLP’s FPDK Excipient Particle
CricketTM Inhalation Device
No Self-
Refrigeration Administered

13. “Universal” or “Broadly Neutralizing” VLP Vaccine
TechnoVax is developing a Concept of Universal Vaccine and Identification of
Broadly Neutralizing Antibody in Humans.
Highly conserved
subdominant epitopes are
masked and poorly
recognized by the immune
systems
HA antigenic variation:
Drift and shift

14. Modified HA Molecules
HA2: 347-520
B
HA1: 241-346
HA2: 347-520 Transmembrane and cytoplasmic
domain: 521-568
C
A
Transmembrane and cytoplasmic
domains: 521-568 Interior of VLP
Interior of VLP
HA1: 281- C
346
HA2: 347-
12 amino acid B 520
linker
A
HA1: 17 - 65 D
Transmembrane and
cytoplasmic domain:
Interior of VLP 521-568
Different structures of HA molecules without immuno-
dominant antigenic sides

15. Evaluation of Induction of Neutralizing Antibodies
Elicitation of neutralizing antibodies by
remodeled HA VLP vaccines is
evaluated by an in-vitro micro-
neutralization assay.
Mixtures of virus/antibodies are
applied to MDCK cells and infection is
assayed by detecting expression of
influenza NP protein using an ELISA
test.

16. TechnoVax’ VLP Approach For RSV Vaccine
Most important cause of lower respiratory tract infection (LRI) in
infants, children and the elderly worldwide
Target antigens
Single antigenic VLP
VLP scaffold
Multiple antigenic VLP
Target antigens are incorporated on the surface of the VLP structure
as a repetitive array of a single antigen or in combination with other
molecules forming multiple antigenic VLP structures

17. Respiratory Syncytial Virus-Like Particles (RSVLPs)
Gradient purified respiratory syncytial virus-like particles
(VLPs), produced in CHO, were negatively stained and
examined by electron microscopy. The micrograph
shows spherical particles (80-100nm) decorated with
surface projections or “spikes” of the fusion protein F
resembling the morphology of respiratory syncytial virus
(RSV).
NIH sponsored animal studies in cotton
rats planned for Dec.12/Jan.13 at Baylor
Medical College.

18. Other VLP Vaccines under Preparation
Dengue vaccine:
• Preparation of monovalent vaccines to evaluate efficacy in in-vitro
nutralization studies.
• Tetravalent possibly at later stage.
Cancer and HIV vaccines:
• Early concepts
VLP Delivery System:
• Early concept: using VLP to carry small molecules and target desired cells.

19. Strategy: Flexible Win-Win Partnerships
TechnoVax is seeking Partnerships to create
“Win-Win” Solutions
Focused on Moving Preclinical
Candidates to Clinical Proof-of-Concept
and towards Markets.
Target ID Discovery Preclinical Phase 1 Phase 2 Phase 3 NDA
Area of Partnership for TechnoVax and Pharma:
• TVx brings product expertize and initial R&D funding.
• Pharma Partner provides necessary resources to advance
candidate through clinical POC.

20. Capital Efficient Milestone-Driven Partnerships
Defining optimal path to proof-of-concept with Partner:
 Managing key variables of time, capital, data
 Development risk management
Milesones: Exercise
• Tox Option: Phase 3
Formation • IND • Yes/No NDA
• Phase 1 • Geography Marketing
• Phase 2 • FRF
Reduced Reduced risk Pre-defined Pharma to
upfront cost of clinical Option Cost market
of entry. proof of maximizing candidate as
concept investment per chosen
financing. return and option for
minimizing royalty.
project risk.

21. Acknowledgements:
TechnoVax Baylor College of Medicine
Ms. Hinna Ziaullah Dr. Innocent Mbawuike and Team
Mr. Anil Bhates
Dr. Diana Dalfo City College of New York (CUNY)
Dr. Hui-Ting Cheng Dr. Paul Gottlieb and Team
Dr. George Martin
Mr. Hector Munoz
Thank you
TechnoVax, Inc.
765 Old Saw Mill River Rd
Tarrytown, NY 10591
Tel. +1 (914) 345-52300
Fax +1 (914) 345 6104
www.TechnoVax.com