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BioLume Presentation January 10, 2007 BioLume BioLume Mission …..to develop and commercialize a broad library of proprietary bioluminescent proteins with multiple first-in-class applications in diagnostic imaging, food, beverage, and cosmetics….. BioLume BioLume Imaging Patents • Detection and visualization of neoplastic tissues and other tissues –U.S. 6,416,960 issued July 9, 2002 –U.S. 6,596,257 issued July 22, 2003 –U.S. 09/746485 filed December 22, 2000 • Broad claims e.g., “A diagnostic system containing a bioluminescence generating system” • Backed up by broad composition of matter patents BioLume What is Bioluminescence? Bioluminescence is light produced by a chemical reaction within a living organism BioLume Bioluminescent Proteins OXYGEN o COELENTERAZINE (Z) + ENZYME "LUCIFERASE" + COMPLEX o o o o c + CO2 BioLume Visible light Bioluminescent Proteins BioLume’s bioluminescent proteins were cloned from various deep-sea marine organisms BioLume Bioluminescent Proteins Sardines, Herring, Haddock, Tuna, Salmon, and Mackerel all have diets rich in bioluminescent organisms and contain luciferases and their substrate coelenterazine BioLume Bioluminescent Proteins Food squid observed during fishery collection BioLume Bioluminescent Protein Safety These proteins have already been tested for skin, eye, and oral toxicity (both acute and sub-acute) These proteins were negative for mutagenicity in the Ames test. Many pharmaceutical and university research laboratories have maintained animals expressing Luciferase, with no reports of toxicity or failure of animals or cells to thrive due to their presence. Coelenterazine is a natural antioxidant BioLume Molecular Imaging Molecular imaging represents a paradigm shift in the focus of medical imaging from the visualization of anatomy and physiology to the study of metabolic and physiological processes e.g., cancers, often in real time BioLume Molecular Imaging Recent advances in biotechnology have enabled in vivo molecular imaging of luciferase reporter proteins in living animals by using a cooled charge-coupled device (CCD) camera. BioLume Bioluminescent Imaging BioLume Molecular Imaging Because bioluminescence imaging has minimal background activity, this technology is very sensitive for detecting light emitted from luciferases BioLume Bioluminescent Imaging BioLume Bioluminescence Molecular Imaging with renilla luciferase BioLume Bioluminescent Imaging BioLume Bioluminescent Imaging BioLume Bioluminescent Imaging BioLume Bioluminescent Imaging BioLume Skin Cancer Facts • >1 million new cases of skin cancer will be diagnosed in the US this year (>10k will die) • 1 in 5 Americans will develop skin cancer during their lifetime (BCC, SCC, or melanoma) • 1 in 65 Americans were likely to develop melanoma during their lifetime • Melanoma incidence has increased 690% since 1950 • Melanoma is the second most common cancer in women aged 20 to 29 BioLume Source: American Academy of Dermatology Skin Cancer Detection • Screening for skin cancer is a visual exam by patient or dermatologist • Suspicious lesions get a biopsy • Highly specific antibodies for melanoma are known and generically available • There are no skin cancer screening kits on the market today BioLume Immunology of Melanoma There are unique surface antigens which characterize melanoma cells These unique antigens can be used to target highly specific antibodies, for therapy or detection BioLume Immunology of Melanoma One type of surface antigen is a ganglioside (GM3) Antibodies have been made which are directed against these gangliosides as well as other melanoma surface antigens BioLume Selective melanoma antibody kill melanoma cells BioLume Bioluminescent Melanoma Detection Luciferases can be expressed with antibodies to melanoma surface antigen(s) Or Luciferases can be chemically conjugated to the melanoma antibodies BioLume Summary • Product development opportunity combining known antibodies and developed bioluminescent proteins (no research required) • Patented bioluminescent proteins • Focused on an unmet medical need • Large market opportunity BioLume