TechnoVax presented at the Life Sciences & Healthcare Venture Summit 2013 in NYC last week. If you missed this opportunity to learn more about our new vaccine technologies and programs, here is the presentations. Should you have any questions or are interest in learning more about us, please don't hesitate to contact me at hmunoz@technovax.com.
Thanks,
Hector Munoz
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TechnoVax Presentation at LSHVS 2013
1. Unique & Novel
Vaccine Technologies
Hector Munoz, MBA
Chief Financial & Corporate Development Officer
TechnoVax, Inc.
765 Old Saw Mill River Road,
Tarrytown, New York
2. CREATING A NEW GENERATION OF VACCINES
• TechnoVax is a biotechnology company based in the New York metro area.
Our Mission is to create and advance Unique and Novel vaccine
technologies with no current alternatives through achieving:
GROUNDBREAKING CONCEPTS
OPTIMIZED EFFECTIVENESS
UPMOST SAFETY
• To achieve our mission, TechnoVax seeks:
strategic cooperations and partnerships to support vaccine
programs and advance candidates toward the market.
3. DYNAMIC TEAM, BIG IDEAS!
TechnoVax functions as a semi-virtual biotech company. The core team is composed of 6-9
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
Dr. George Martin (PhD), co- external collaborators from well known
founder is Scientist Emeritus at the institutions such as Baylor
NIH and former Sr VP for Scientific College of Medicine, New
Affairs of Fibrogen, Inc.
York Medical College and
CUNY (City University of New York).
Hector Munoz (MBA), +20 years
in international Corporate M&A and
Business Development.
Dr. Jose Galarza (DVM, PhD.), founder, is the Pioneer of the influenza Virus-
Like Particle (VLP) Vaccine Technology. With more than 27 years of scientific
experience in the field of virology and vaccine development, he was Principal
Scientist and leader of the influenza subunit vaccine development program in the
Vaccines Division of Wyeth Pharma.
4. WHAT WE DO
Unique and Novel cell-based produced VLPs (Virus-Like Particle) and
• Our
Inhaled Powder platforms are used to develop and produce vaccines
against infectious diseases such as:
Influenza (mono or multivalent, Universal flu vaccine)
respiratory syncytial virus (RSV vaccine),
para-influenza (PIV) and other diseases including Dengue, HIV and cancer.
5. 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.
High Priority Candidate
6. PROPOSED NOVEL VACCINES FOR PARTNERSHIP
“INHALED POWDER” VACCINES (FLU AS INITIAL TARGET)
“RSV-LP” VACCINE
“UNIVERSAL” FLU VACCINE
Market Snapshot:
Prospective addressable market of over US$5 billion in annual worldwide sales:
Influenza Vaccine Market: market size:300+M doses / $3.0+bn
Worldwide: affects severely 3-5 M people & 250-500 thousand deaths.
RSV Vaccine Market: market size: ~50M doses / $1.5bn
Worldwide: affects 64 M people & 160,000 deaths. USA: about 100,000 infant and
175,000 elderly hospitalizations, 14,000 elderly deaths. There is no vaccine available.
Dengue Vaccine Market: market size: ~100M doses / $0.5bn.
33% of the world’s population lives in areas at risk. Leading cause of illness and death
in the tropics and subtropics. 100 M people are infected yearly. There is no vaccine.
7. “INHALED-POWDER” VACCINES
“Shelf-Stable, Self-Inhaled, Powderized” VLP Vaccines
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
No Self-
Refrigeration! Administered!
CricketTM Inhalation Device
8. “INHALED-POWDER” VACCINES
• Groundbreaking Concept:
– Shelf-Stable vaccine requiring no refrigeration: Elimination of Cold Chain distribution
(improved costs and inventory management, etc.).
– Extended Shelf Live.
– Allows for Self Administration, reducing cross infection risks at point of administration
(limits propagation of virus in the event of a pandemic).
– To be the First Company to launch an Inhaled Powder vaccine on the market.
• Optimized Effectiveness:
– Best Route of Immunization
(mucosal surface - respiratory track)
– Increased Patient Acceptance (inhaled
vs. injection)
– Pre-clinical studies in mice demonstrate
Immunogenicity and Protective
Efficacy (either inhaled powder or i.m.
solubilized powder delivery methods).
• Upmost Safety:
– Proven VLP Technology.
– Proven Inhaled technology.
– No Infectious or Replicating agents
9. “RSV-LP” VACCINE
Most important cause of lower respiratory tract infection (LRI) in
infants, children and the elderly worldwide.
Target antigens are incorporated on the surface of
Target antigens the VLP structure as a repetitive array of a single
antigen or in combination with other molecules
Single antigenic VLP forming multiple antigenic VLP structures
VLP scaffold
Multiple antigenic VLP
EM of gradient purified Respiratory Syncytial
Virus-Like Particles (RSV-LP), produced in CHO
cells, negatively stained. Particles (~90nm) are
decorated with “spikes” of the fusion protein F.
NIH sponsored animal studies in
cotton rats started mid-January
2013 at Baylor Medical College.
10. “RSV-LP” VACCINE
• Groundbreaking Concept:
– NO RSV vaccine currently on the market.
– Technology extremely well suited for all age groups including pregnant women
and the elderly population.
– Potential to introduce a Powder RS-VLP vaccine:
– To be a Leading Company to launch an RSV vaccines on the market.
• Optimized Effectiveness:
– No RSV vaccine currently on the market.
– Proven VLP technology
– Best Route of Immunization (Powder RS-VLP vaccine)
• Upmost Safety:
– Proven VLP technology.
– No Infectious or Replicating agents.
11. “UNIVERSAL” FLU VLP VACCINE
Our Universal Flu Vaccine is based on VLPs assembled with Remodeled
HAs exhibiting highly conserved subdominant epitopes able to elicit
Broadly Neutralizing Antibody responses in Humans.
Highly conserved
subdominant epitopes are
masked and poorly
recognized by the immune
systems
HA antigenic variation:
Drift and shift
12. “UNIVERSAL” FLU VLP VACCINE - Modified HA Molecules
B
HA2: 347-520
HA1: 241-346
HA2: 347-520
Transmembrane and cytoplasmic
C domain: 521-568
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
Structures of HA molecules displaying prevalent conserved
subdominant epitopes able to elicit broadly neutralizing antibodies.
13. “UNIVERSAL” FLU VLP VACCINE
• Groundbreaking Concept:
– Cross Protection against Multiple influenza Strains.
– Reduced Frequency of immunization (longer protection).
– Improved production Planning (manufacturing, storage and distribution).
– To be a Leading Company to launch a Universal flu vaccine on the market.
• Optimized Effectiveness:
– Improved effectiveness due to Cross
Protection against various Sub-Types and
Antigenic Drift.
– Better patient Acceptance (reduced
immunization frequency)
– VLP constructs, (3TA and 5TA VLPs) induced
antibodies able to neutralize the
homologous virus strains
• Upmost Safety:
– Proven VLP technology.
– No Infectious or Replicating agents.
14. FLEXIBLE WIN-WIN PARTNERSHIPS
TechnoVax is seeking Financial Partners to create “Win-Win” Solutions
Focused on Moving Preclinical Candidates to Clinical Proof-of-Concept
and towards a potential Exit after Clinical Phase I/II.
Discovery Preclinical Phase 1 Phase 2 Phase 3 NDA
Area of Partnership for TechnoVax and Financial Partner:
• TVx brings product expertize and initial R&D funding: over $5.0 million YTD.
• Financial Partner provides necessary resources to advance candidate through
clinical POC. $2.5 to 5.0 M to bring one or two candidates through
clinical Phase I.