NOVEL PLATFORMS FOR CANCER DIAGNOSIS

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1 NOVEL PLATFORMS FOR CANCER DIAGNOSIS Luca Beneduce, Ph.D. Founded in 2001 and headquartered in Venice (Italy) Xeptagen is a privately held biotech company funded by venture capital. Xeptagen s mission is to discover and validate new biomarkers for the development of innovative diagnostic in oncology. Four highly innovative products for early detection of cancer already on the market and a strong pipeline giving access to a US$1.2bn potential market.

2 US Mortality Rank Cause of Death No. of deaths % of all deaths 1. Heart Diseases 652, Cancer 559, Cerebrovascular diseases 143, Chronic lower respiratory diseases 130, Accidents (unintentional injuries) 117, Diabetes mellitus 75, Alzheimer disease 71, Influenza & pneumonia 63, Nephritis* 43, Septicemia 34, *Includes nephrotic syndrome and nephrosis. Source: US Mortality Data 2005, National Center for Health Statistics, Centers for Disease Control and Prevention, Change in the US Death Rates by Cause ,8 Rate Per 100, ,1 180, ,9 183, ,6 48,1 20,3 0 Cardiopathy Cerebrovascular Diseases Influenza & Pneumonia Cancer * Age-adjusted to 2000 US standard population. Sources: 1950 Mortality Data - CDC/NCHS, NVSS, Mortality Revised Mortality Data: US Mortality Data 2005, NCHS, Centers for Disease Control and Prevention, 2008.

3 5-Years Relative Survival Rates by Stage Five-Year Relative Survival Rates Breast Colon Kidney Larynx Melanoma Oral cavity & pharynx Ovary Urinary bladder Uterine cervix Uterine corpus Local Regional Distant Cancer Stage CANCER BIOMARKERS EARLY DETECTION SCREENING MONITORING Conventional serum biomarkers DISEASE LIVER CANCER COLON CANCER BREAST CANCER PROSTATE CANCER DIAGNOSIS AFP (?)* NO MARKER NO MARKER PSA (moderate) PROGNOSIS AFP (good) FERRITIN (?) CEA (moderate) CA 19.9 (?) CA 15.3 (moderate) CEA (?) PSA (good) chromogranin A (?) MONITORING OF THERAPY AFP (moderate) FERRITIN CEA (moderate) CA 19.9 (?) CEA (?) PSA (good) chromogranin A (?) Low sensitivity (5-50%) Useless for early detection Combination decreases specificity LUNG CANCER NSE (?) LDH (?) NSE (?) CYFRA 21.1(?) CEA (?) * Evidence Based Score: (?) Indicates no evidence based score

4 WHAT S S THE NEXT IN CANCER DIAGNOSIS MORE SENSITIVE & SPECIFIC BIOMARKERS (VALIDATED) MEDICAL NEED EASY TO HANDLE (IN VITRO USE) SMALL AMOUNT OF MATERIAL REQUIRED PREDICTING PATIENT EVOLUTION PREDICTING RESPONSE TO THERAPY: THE ERA OF THERANOSTICS DECENTRALIZED TESTING: FROM HOSPITAL TO POINT-OF-CARE TO HOME MOLECULAR PROFILING FOR PERSONALIZED MEDICINE: ONE PATIENT, ONE CARE PARALLEL ANALYSIS FOR BIOMARKERS COMBINATION ANSWER: NOVEL BIOMARKERS & NOVEL DEVICES FOR NANOSENSING CANCER IMMUNOEDITING Equilibrium (cancer persistance) Elimination (cancer suppression) linfociti, NK cells e macrofagi carcinogenesis repair Escape (cancer progression) Natural IgM antibodies are the first defense effectors against pathogenic organisms and transformed malignant cells Many cancer biomarkers may be detected in the patients sera also as IgM immune complexes Beneduce et al., Cancer Detect Prev, 2007 IgM immune complexes: a novel class of cancer biomarkers

5 PRODUCTS ON THE MARKET Hepa-IC ELISA Kit for Hepatocellular Carcinoma (HCC) Detection, Monitoring and Response to Therapy 70% Sensitivity, 100% specificity over control Predicts chronic hepatitis (CH)/cirrhotic (CR) patient evolution Detects CH patients response to interferon and lavimudine References: Cancer; 103: , Int J Cancer 2006,119: Dig Liv Dis; 37(3):A38-A39, J.Hepatology; 42 : 132, J. Hepatology, 40 (suppl.1):77, 2004, Dig Liv Dis, 36:A2-3, 2004 Metodo di diagnosi altamente specifico per neoplasie XEPTAGEN S.p.A. Italian Application No PD2003A Specific method for cancer detection XEPTAGEN S.p.A. PCT /IT04/583 PRODUCTS ON THE MARKET Colon-IC ELISA KIT for colorectal cancer (CRC) early detection (stage 1) (serum) % Test positivity References: Int J Biol Markers 2005, 20: Metodo di diagnosi altamente specifico per neoplasie XEPTAGEN S.p.A. Italian Application No PD2003A Specific method for cancer detection XEPTAGEN S.p.A. PCT /IT04/583 CEA-IgM & CEA CEA-IgM CEA Stage Progression I II III IV Detects 38% of patients in stage I colon-rectal cancer Combined with CEA, raises sensitivity to 60%

6 PRODUCTS ON THE MARKET PROSTATE-IC ELISA Kit for Prostate Cancer Detection Much higher specificity than PSA pathology Cancer hyperplasia biomarker PSA-IgM cut off = 145,1 AU/mL PSA cut-off= 4 ng/ml PSA cut-off= 10 ng/ml fpsa/tpsa cut-off=25% PSA-IgM cut-off= 145,1 AU/mL PSA cut-off= 4 ng/ml PSA cut-off= 10 ng/ml positivity 20/50 (40%) 44/50 (88%) 12/50 (24,9%) 46/50 (92%) 6/49 (11,8%) 47/49 (95,9%) 14/49 (28,6%) References: Cancer Detect Prev. (2007) 31, 402-7, Metodo di diagnosi altamente specifico per neoplasie XEPTAGEN S.p.A. Italian Application No PD2003A Specific method for cancer detection XEPTAGEN S.p.A. PCT /IT04/583 MULTI-MARKERS MARKERS PROFILING Products in development Biochip for simultaneous, multi markers - immune complexes profiling for the highest sensitive and specific detection of Hepatocellular Carcinoma (HCC) and other cancer forms Competive advantages: B i o - L i v e r X E P T A G E N Lot 1309HB 07 Highest sensitivity and specificity Simultaneous analysis Non invasive procedure Possible early diagnosis of tumors Screening method for monitoring high-risk populations

7 BIOCHIP DEVELOPMENT: MAIN ISSUES Sensibility adequate for clinical use: signal/noise ratio should be at least equivalent to (or better than) conventional diagnostics devices Reproducibility in fabrication: CV spot to spot and biochip to biochip equal or less than conventional diagnostics (ELISA) Low cost for massive production: much less than conventional ELISA s. Biochip should be disposable Extended shelf life: more than conventional ELISA s (> than 6 months) Easy of use: no expensive equipment required to read the biochip MULTI-MARKERS MARKERS BIOCHIP The early diagnosis of Hepatocellular Carcinoma Sample withdrawal Detection Sample deposition on biochip Results

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