TechnoVax Presentation at LSHVS 2013

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Hector Munoz, MBA Chief Financial & Corporate Development Officer TechnoVax, Inc. 765 Old Saw Mill River Road, Tarrytown, New York Unique & Novel Vaccine Technologies

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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 [email protected]. Thanks, Hector Munoz

Transcript of TechnoVax Presentation at LSHVS 2013

Page 1: TechnoVax Presentation at LSHVS 2013

Hector Munoz, MBA

Chief Financial & Corporate Development Officer

TechnoVax, Inc.765 Old Saw Mill River Road,

Tarrytown, New York

Unique & NovelVaccine Technologies

Page 2: TechnoVax Presentation at LSHVS 2013

CREATING A NEW GENERATION OF VACCINES

• TechnoVax is a biotechnology company based in the New York metro area.

• To achieve our mission, TechnoVax seeks:

strategic cooperations and partnerships to support vaccine

programs and advance candidates toward the market.

Our Mission is to create and advance Unique and Novel vaccine

technologies with no current alternatives through achieving:

GROUNDBREAKING CONCEPTS

OPTIMIZED EFFECTIVENESS

UPMOST SAFETY

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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).

DYNAMIC TEAM, BIG IDEAS!

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.

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. George Martin (PhD), co-founder is Scientist Emeritus at the NIH and former Sr VP for Scientific Affairs of Fibrogen, Inc.

Hector Munoz (MBA), +20 years in international Corporate M&A and Business Development.

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• Our Unique and Novel cell-based produced VLPs (Virus-Like Particle) and

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.

WHAT WE DO

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Working on a Strong Pipeline for the Future

Flu Vaccines:

TechnoVax is planning to file for an IND for its lead Seasonal Fluvaccine 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

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PROPOSED NOVEL VACCINES FOR PARTNERSHIP

“INHALED POWDER” VACCINES (FLU AS INITIAL TARGET)

“UNIVERSAL” FLU VACCINE

“RSV-LP” 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+bnWorldwide: 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.

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Flu VLP’s FPDK Excipient Particle

CricketTM Inhalation Device

“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.

No Refrigeration!

Self-Administered!

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• 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.

“INHALED-POWDER” VACCINES

• 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

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“RSV-LP” VACCINE

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 Single antigenic VLP

Multiple antigenic VLP

VLP scaffold

Target antigens

Most important cause of lower respiratory tract infection (LRI) in infants, children and the elderly worldwide.

NIH sponsored animal studies incotton rats started mid-January2013 at Baylor Medical College.

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.

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“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.

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Highly conserved subdominant epitopes are

masked and poorly recognized by the immune

systems

HA antigenic variation:

Drift and shift

“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.

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HA2: 347-520

HA1: 241-346

Interior of VLP

Transmembrane and cytoplasmic

domains: 521-568

A

B

C

“UNIVERSAL” FLU VLP VACCINE - Modified HA Molecules

Transmembrane and cytoplasmic domain: 521-568

HA2: 347-520

HA1: 281-346

HA1: 17 - 65

12 amino acid linker

Interior of VLP

B

C

A D

Transmembrane and cytoplasmic

domain: 521-568

HA2: 347-520

Interior of VLP

Structures of HA molecules displaying prevalent conserved

subdominant epitopes able to elicit broadly neutralizing antibodies.

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• 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.

“UNIVERSAL” FLU VLP VACCINE

• 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.

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FLEXIBLE WIN-WIN PARTNERSHIPS

TechnoVax is seeking Financial Partners to create “Win-Win” SolutionsFocused on Moving Preclinical Candidates to Clinical Proof-of-Conceptand 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.

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Contact:

Hector MunozChief Financial & Corporate Development Officer

[email protected]. +1 (914) 345-52300 x12

www.TechnoVax.com

Together, developing

Unique & NovelVaccines!

Thank You!