Technovax Presentation @ Influenza Congress USA 2012
VLPs A Vaccine Platform for the future!Innovative Technologies for Respiratory Vaccines Influenza Congress 2012 Washington, DC, November 2012 Hector Munoz – Corp. Dev.
Welcome to TechnoVax• TechnoVax is a biotechnology company based in Tarrytown - Westchester County (New York) that specializes in Viral Vaccine Development.
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.
Dynamic Team, Big Ideas!TechnoVax functions as a semi-virtual biotech company. The core team is composed of 9 fulltime 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.
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.
TechnoVax’s VLP TechnologyTechnoVax and its team of scientists have developed a new way to produce highlyimmunogenic, 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!
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.).
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
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
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.
“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.
“Self-Inhaled Powderized” Influenza VLP VaccineTechnoVax and MannKind Corp. have combined their respectivetechnologies to create a Powder Formulation of VLP InfluenzaVaccine for Intrapulmonary Self-Delivery by Inhalation. Flu VLP’s FPDK Excipient Particle CricketTM Inhalation Device No Self- Refrigeration Administered
“Universal” or “Broadly Neutralizing” VLP VaccineTechnoVax is developing a Concept of Universal Vaccine and Identification ofBroadly Neutralizing Antibody in Humans. Highly conserved subdominant epitopes are masked and poorly recognized by the immune systems HA antigenic variation: Drift and shift
Modified HA Molecules HA2: 347-520 BHA1: 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
Evaluation of Induction of Neutralizing AntibodiesElicitation of neutralizing antibodies byremodeled HA VLP vaccines isevaluated by an in-vitro micro-neutralization assay.Mixtures of virus/antibodies areapplied to MDCK cells and infection isassayed by detecting expression ofinfluenza NP protein using an ELISAtest.
TechnoVax’ VLP Approach For RSV VaccineMost important cause of lower respiratory tract infection (LRI) ininfants, children and the elderly worldwide Target antigens Single antigenic VLP VLP scaffold Multiple antigenic VLPTarget antigens are incorporated on the surface of the VLP structureas a repetitive array of a single antigen or in combination with othermolecules forming multiple antigenic VLP structures
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.
Other VLP Vaccines under PreparationDengue vaccine:• Preparation of monovalent vaccines to evaluate efficacy in in-vitro nutralization studies.• Tetravalent possibly at later stage.Cancer and HIV vaccines:• Early conceptsVLP Delivery System:• Early concept: using VLP to carry small molecules and target desired cells.
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.
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.
Acknowledgements:TechnoVax Baylor College of MedicineMs. Hinna Ziaullah Dr. Innocent Mbawuike and TeamMr. Anil BhatesDr. Diana Dalfo City College of New York (CUNY)Dr. Hui-Ting Cheng Dr. Paul Gottlieb and TeamDr. George MartinMr. 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