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Protein Delivery Sciences. Overview of PDS Biotechnology. Versamune TM nanotechnology Curative and protective, immunotherapeutic nano -particle technology Applicable to unmet clinical needs in infectious diseases and cancer Lead product – HPV infection and cancer Product 2 - Melanoma

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Presentation Transcript

Overview of PDS Biotechnology

  • VersamuneTM nanotechnology

    • Curative and protective, immunotherapeutic nano-particle technology

  • Applicable to unmet clinical needs in infectious diseases and cancer

    • Lead product – HPV infection and cancer

    • Product 2 - Melanoma

  • Experienced management team


Management Team

  • Frank Bedu-Addo, Ph.D. – President and CEO

    • KBI BioPharma, Cardinal Health, Schering-Plough, Elan

    • Overseen operations/P&L: Pharma & emerging biotech

  • Gregory Conn, Ph.D. – Chief Scientific Officer

    • 35 years expertise, Merck, Regeneron, Covance Biotech

    • 8 Drug patents

  • Leaf Huang, Ph.D.(Distinguished Chair, Pharmaceutics, UNC Chapel Hill - Scientific founder, R&D Support)


Advisory Teams

  • Board of Directors

    • De Lyle Bloomquist (CEO, General Chemical Products)

    • Cameron Durrant, M.D. (Global VP, Infectious Dis., Strategic Marketing, Johnson & Johnson)

    • Ron Labrum (CEO, Fenwal, Inc.)

    • Kent Payne, Ph.D. (VP, GM Cardinal Health Pharmaceutical Development, now Catalent Pharma)

  • Scientific Board (External Members)

    • Darron Brown, M.D. (Professor, Infectious Diseases, IU)

    • Mark Einstein, M.D. (Director, OBGYN, Montefiore Med. Ctr.)

    • Michel Klein, M.D. (CEO Canvac)

    • Lisa Rohan, Ph.D. (Assist. Prof. Pharmaceutics, Univ. of Pitt)


Single Dose VersamuneTM-HPV Therapy Induces Complete Tumor Regression in Pre-clinical Studies

Cancer Immunology Immunotherapy 57, 2008




The Unique Dual Mechanism of VersamuneTM

Mol. Immunology 44, 2007


The Unique Dual Mechanism of VersamuneTM

Mol. Immunology 44, 2007


The Unique Dual Mechanism of VersamuneTM

Mol. Immunology 44, 2007


The VersamuneTM Solution

  • Highly Potent Cures and Prevention

    • Demonstrated in HPV-related cancer

    • Demonstrated in Melanoma (NIH funded )

  • Simple and cost effective

    • Nanoparticles + disease-associated protein

  • Safe and Unique Mechanism of Action

    • Activates MAP Kinase

    • NIH funded toxicology: Safety at > 40X therapeutic dose


VersamuneTM - Intellectual Property

  • The technology involving the use of cationic lipids in immunotherapies was acquired by PDS Biotechnology in June 2006

  • Patent # 7303881, issue date 12/04/2007

  • 3 Additional composition and application patents filed in 2008-2009


Business Strategy and Revenue Generation

  • Phase 1 human clinical trials (2010)

    • FDA IND submission Q1 2010

  • Revenue generation

    • Strategic technology out-licensing (2010/2011)

    • Commercialize and market PDS proprietary products (2015/2016)


Partnerships

  • Merck AG – 2009

    • Exclusive IP and Supply Agreement

  • National Cancer Institute’s Nanotech Lab (NCL) – 2008

    • PDS selected as affiliate

    • NCL funded collaboration towards clinical trials

  • Leading US Academic Institution - 2007

    • Sponsored research agreement

    • PDS maintains IP


Selected Highlights

  • VersamuneTM-HPV IND Studies

    • In-vivo toxicology: Safe >40X active dose (NIH-funded)

    • In-vitro immunology and toxicology: Safe profile (By NCL)

    • High efficacy in human model systems (NIH-funded)

    • Robust manufacturing process and product stability


Funding

  • $4M raised 2006-2008

  • $8-10M Series A in 2009

    • $5.5 M - VersamuneTM-HPV

      • GMP manufacturing

      • Phase I clinical trials

    • $3.0M – Indications 2 & 3

      • VersamuneTM-Melanoma

      • VersamuneTM-Hepatitis or Herpes

        • Complete IND (2011/2012)


In Summary

  • A unique platform with solid patent position for immunotherapeutic products

  • Simple, safe, cost effective and potent immunotherapy treatments for cancer and infectious diseases

  • Superior efficacy in head-to-head with top technologies

  • Strong management team with stellar track record in management and drug development

  • Raising $10M in Series A


Thank You

Frank Bedu-Addo, Ph.D. - President and CEO

[email protected]

Tel: 513-807-6840

www.pdsbiotech.com


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