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STELLAR BIOTECH INC Message Board

  • robert.vince robert.vince Feb 25, 2013 9:43 AM Flag

    Stellar presentation

    Only company that can ensure long-term
    KLH supply

    ●  We protect source and control KLH quality

    ●  We turn KLH science into breakthrough products

    Proprietary Land-Based Aquaculture
    Scalable Capacity
    Patented Protein Extraction

    3

    Production History & Capacity


    1999

    2003

    2004-2006

    2007-2012 2013



    • Aquaculture systems

    • Supplier KLH

    • Commercial contracts

    • Patents for key technology

    • NIH grants

    • GMP grade
    KLH

    • suKLH for Phase I-III clinical trials

    • NCI grants

    • ASP KLH for SAFC HMW KLH

    • Functional assays

    • Immunotox studies

    • National Science Foundation

    • Supply capacity for clinical trials

    • Scalable capacity for commercial contracts

    • Supply chain control


    World Leader in Sustainable KLH Manufacture

    4

    KLH: Essential Immune Tool
    Over 100 clinical trials, 22 currently recruiting
    Oncology, Autoimmune, Alzheimer’s, Infectious Disease

    Vaccine Carrier
    Ideal carrier molecule

    Vaccine Adjuvant

    Stellar
    KLH

    Safe, potent, targeted

    Immune Function
    Monitor patient status

    Drug Development
    Superior TDAR testing


    5

    Stellar’s KLH Supply Proposition
    Quality. Sustainable Supply. Control.

    Megathura. crenulata – Giant Keyhole Limpet

    ●  Only source of KLH protein

    ●  Found only on California coast

    ●  Small population is threatened by:
    •  Unregulated fishery
    •  Growing use in cancer vaccines & diagnostics
    •  International commercial interests

    Stellar Biotech Leadership


    • Controlled production colonies
    • Land-based aquaculture
    • Patented, sustainable KLH extraction
    • Transferrable to multiple sites


    • Quality traceable to source
    • Multi-kilogram scalable supply
    • Control over source of supply


    6


    Products

    ●  GMP Subunit KLH

    ●  GMP HMW KLH

    ●  Research Grades KLH

    ●  ASP Bulk Intermediate

    ●  Immunodiagnostic Assays

    New Developments at Stellar

    ●  Infectious Disease Vaccines

    l  KLH conjugate vaccines for recurring Clostridium difficile infection

    •  Carbohydrate vaccine

    •  Glycoprotein vaccine

    ●  Novel Adjuvants

    l  KLH combinatorial scaffolds

    •  Synergy of different Pattern Recognition Receptors (PRRs)
    on KLH scaffold

    l  Selective targeting of different Antigen Presenting Cells

    l  Selective activation of Th1, Th2, Th17 and Treg pathways

    Stellar KLH™
    Quality Control Compliance

    U.S. Pharmacopeial (USP) Standards are highly-characterized physical characteristics used in testing by pharmaceutical and related industries to help ensure quality of medicines including drugs, biologics, drug substances and excipients.

    All lots of Stellar KLHTM are tested under USP standards to confirm that the final product quality conforms to its identity, strength, and purity.

    Stellar Opportunities & Programs


    Stellar Targets:

    ●  Infectious Diseases

    ●  Oncology

    ●  Autoimmune Diseases


    ●  Rheumatoid Arthritis

    ●  Immune Function

    ●  Alzheimer’s


    Examples:

    Applica'on Vaccine/An'gen Use

    Non-­‐Hodgkins Lymphoma AnD-­‐Idiotype Vaccine Stellar KLH™ conjugate Rheumatoid ArthriDs TNF-­‐alpha Kinoid Stellar KLH™ conjugate Lupus IFN-­‐alpha Kinoid Stellar KLH™ conjugate Breast Cancer STn-­‐KLH Stellar KLH™ conjugate Bladder Cancer KLH Stellar KLH™
    Immune SDmulant KLH Stellar KLH™

    Pediatric Sarcoma IFN-­‐gamma Stellar KLH™ pulsed DC
    10

    Supply Chain Control

    ●  KLH Source

    l  Secure

    l  Scalable & transferable

    l  Documented traceability

    l  Control of production colonies

    l  Reproducible & environmentally sound

    ●  KLH Process & Purification

    l  Sustainable protein extraction

    l  13+ years of KLH production history

    l  FDA & EMEA regulatory support

    Stellar Partnership Models

    ●  Secure Access to KLH Source

    l  Clinical Stage through Long-Term Commercialization

    l  Supply Assurance & Scale-Up

    ●  Method Development

    l  Access to Stellar IP

    l  Collaboration on New Methods

    l  Joint Ownership of New IP

    Compatibility & Transfer

    ●  Investment Scenarios

 
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