Mosaic 545™ Pathogen Diagnostic Technology Platform Immunotrex Biologics, Inc Syed K. Hasan M.D. Ph.D. – CEO/President Immunotrex Michael McDaniel – CEO/President Infinity Medical Engineering Immunotrex Biologics, Inc. Infinity Medical Engineering, LLC © 2014 Immunotrex Biologics Mosaic 545™ Pathogen Diagnostic Technology Platform Overview Infectious Disease Control Imperative Mosaic 545 Pathogen Identification Diagnostic Procedure Pathogen Identification Mechanism Mosaic 545 Prototype Design Contract Manufacturing Associates Intellectual Property 2/26/2014 © 2014 Immunotrex Biologics 2 INFECTIOUS DISEASE CONTROL IMPERATIVE 2/26/2014 © 2014 Immunotrex Biologics 3 Mosaic 545™ Pathogen Diagnostic Technology Platform Federal Public Health Mandate – Global Intervention Infectious disease is a growing global health threat. As recently as two weeks ago, Health and Human Services Secretary Kathleen Sebelius launched a global effort to “prevent, detect and respond to infectious disease threats where they start”. (Global Health Security Agenda). Infectious disease epidemics originate largely in developing countries. The United States is susceptible to infectious disease transmission by virtue of the increased mobility and interaction of global populations. Human immunodeficiency virus (HIV) serves as a potent reminder. The United States occupies a lead position as a “first responder” to humanitarian crises throughout the world, including infectious disease outbreaks. The ability to diagnose a patient quickly and accurately is critical to containing an outbreak. 2/26/2014 © 2014 Immunotrex Biologics 4 Mosaic 545™ Pathogen Diagnostic Technology Platform Federal Public Health Mandate – Domestic Healthcare The incidence of opportunistic, secondary infection in primary care facilities is increasing at an alarming rate. The costs in patient morbidity and treatment are straining the national healthcare system. A report published in the Journal of Emerging Infectious Diseases, found a 90% increase in reports of MRSA infections among U.S. hospital outpatient admissions from 1999-2006. A 2009 Center for Disease Control study review examining the costs of healthcare associated infections in hospitals estimated the excess hospital cost of healthcare associated infections in the US to be between 28 and 45 billion dollars annually. 2/26/2014 © 2014 Immunotrex Biologics 5 Mosaic 545™ Pathogen Diagnostic Technology Platform Federal Public Health Mandate – National Security In addition to existing and potential infectious disease outbreaks attributable to spontaneous environmental origin, it is incumbent upon the United States to maintain a robust, comprehensive prophylaxis and agile emergency response strategy to combat the possibility of a biological attack. 2/26/2014 © 2014 Immunotrex Biologics 6 Mosaic 545™ Pathogen Diagnostic Technology Platform Federal Public Health Mandate – Improved Patient Care In each scenario “time to diagnosis” is critical. Rapid diagnosis facilitates: Identification and quarantine of infected patients Identification of the infectious agent/pathogen Administration of the appropriate treatment regimen Reduction in duration of symptoms and improved prognosis Reduction in patient length of stay Faster diagnosis, prompt and appropriate medical treatment and reduced duration of hospital stay improve patient quality of life, reduce health care expense and facilitate increased access to immediate care facilities. 2/26/2014 © 2014 Immunotrex Biologics 7 MOSAIC 545 PATHOGEN IDENTIFICATION 2/26/2014 © 2014 Immunotrex Biologics 8 Mosaic 545™ Pathogen Diagnostic Technology Platform Current “State of the Art” – Blood Culture for pathogen identification 2/26/2014 © 2014 Immunotrex Biologics 9 Mosaic 545™ Pathogen Diagnostic Technology Platform Time is Critical When a patient presents with an infection during emergency or intensive care, blood culture can be a race against time. The typical process of pathogen identification in blood takes at least 24 hours. Current methods include culture techniques using agar plates and culture mediums (c. early 1900s) prolonging the process of identification. Culture methods are dependent on producing additional infectious pathogen. 2/26/2014 © 2014 Immunotrex Biologics 10 Mosaic 545™ Pathogen Diagnostic Technology Platform Introducing Mosaic 545™ Real-time positive pathogen identification (< 10 minutes) Sterile, self-contained cartridge Simple on-site use model Multiple samples run simultaneously No culturing of infectious pathogens MOSAIC 545™ utilizes highly conserved species specific oligomer hybridization of small RNA sequences. 2/26/2014 © 2014 Immunotrex Biologics 11 Mosaic 545™ Pathogen Diagnostic Technology Platform Mosaic 545™ Components Sterile, self-contained pathogen identification cartridge Multi-slot cartridge reader Signal processing software Pathogen Identification Cartridge Cartridge Reader Signal Processing Software Pathogen Identification Cartridge Model: _______ Lot # _________ Specimen ID: 2/26/2014 © 2014 Immunotrex Biologics 12 Mosaic 545™ Pathogen Diagnostic Technology Platform Mosaic 545™ Pathogen Identification Cartridge Pathogen Identification Cartridge Model: _______ Lot # _________ Specimen ID: The Pathogen Identification cartridge is the heart of the Mosaic 545. Retractable injector for specimen acquisition Cartridge is self-contained and sterile All reagents and specimen quarantined Pathogen filtration and rRNA isolation Customizable to localized infectious agents Specimen processing eliminates pathogen viability © 2014 Immunotrex Biologics 13 Mosaic 545™ Pathogen Diagnostic Technology Platform Mosaic 545™ Cartridge Reader On-site, immediate, “plug and play” processing Barcode on cartridge corresponds to patient ID Simultaneous processing of multiple cartridges Economical— significantly lower cost per test 2/26/2014 © 2014 Immunotrex Biologics 14 DIAGNOSTIC PROCEDURE 2/26/2014 © 2014 Immunotrex Biologics 15 Mosaic 545™ Pathogen Diagnostic Technology Platform Specimen Is Collected Specimen collection is performed by a trained phlebotomist, medic, or first responder in accordance with standard healthcare best practices. 2/26/2014 © 2014 Immunotrex Biologics 16 Mosaic 545™ Pathogen Diagnostic Technology Platform Specimen Is Injected into Cartridge The Mosaic 545 cartridge has an integral, positive lock injector. The technician engages injector and inserts it into specimen collection tube. 2/26/2014 © 2014 Immunotrex Biologics 17 Mosaic 545™ Pathogen Diagnostic Technology Platform Cartridges Are Inserted into Cartridge Reader Pathogen Identification Cartridge Model: _______ Lot # _________ Specimen ID: A technician inserts the cartridges into the cartridge reader. 2/26/2014 © 2014 Immunotrex Biologics 18 PATHOGEN IDENTIFICATION MECHANISM 2/26/2014 © 2014 Immunotrex Biologics 19 Mosaic 545™ Pathogen Diagnostic Technology Platform Targeted Pathogens and Diseases Bacterial Pathogen Bartonella henselae Cat scratch disease Borrelia burgdorferi Lyme disease Brucella (species) Brucellosis Chlamydia psittaci Psittacosis Clostridium botulinum Botulism Clostridium perfringens Εpsilon Toxin (ε) Cryptosporidium parvum Cryptosporidiosis Escherichia coli O157:H7 Food poisoning Rickettsia prowazekii Typhus fever Salmonella (species) Typhoid fever, food poisoning Shigella dysentariae Severe dysentery Staphylococcus aureus Streptococcus pneumoniae Vibrio cholerae 2/26/2014 Disease Septic shock Multiple, meningitis Cholera gravis © 2014 Immunotrex Biologics 20 The Target: Ribosomal RNA Monoclonal Antibody affinity sensors in the cartridge target highly conserved ribosomal RNA (rRNA) for each pathogen. 2/26/2014 © 2014 Immunotrex Biologics 21 Mosaic 545™ Pathogen Diagnostic Technology Platform Mosaic 545 Component Functions The specimen is filtered, bacteria is lysed, and conserved ribosomal RNA (rRNA) sequences are exposed to reduced graphene oxide (RGO) and fluorescence sensors coated with specific affinity monoclonal antibody mAb. Pathogen Identification Cartridge Cartridge Reader Signal Processing Software Pathogen Identification Cartridge Model: _______ Lot # _________ Specimen ID: 2/26/2014 © 2014 Immunotrex Biologics 22 Mosaic 545™ Pathogen Diagnostic Technology Platform Mosaic 545 Component Functions An internal control validates the cartridge prior to processing. Impedance and fluorescence at each sensor are continuously monitored. The multi-bay cartridge reader can process up to 12 cartridges simultaneously in less than 10 minutes. Pathogen Identification Cartridge Cartridge Reader Signal Processing Software Pathogen Identification Cartridge Model: _______ Lot # _________ Specimen ID: 2/26/2014 © 2014 Immunotrex Biologics 23 Mosaic 545™ Pathogen Diagnostic Technology Platform Mosaic 545 Component Functions Raw data from the cartridge monitoring process is sent directly to a PC. Signal processing identifies valid sensor signals and specific pathogen(s). The specimen bar code links the data to the patient record. Results are transmitted via multiple communication portals. Pathogen Identification Cartridge Cartridge Reader Signal Processing Software Pathogen Identification Cartridge Model: _______ Lot # _________ Specimen ID: 2/26/2014 © 2014 Immunotrex Biologics 24 Mosaic 545™ Cartridge Schematic CTRL Electric Terminals Bimodal Sensor Assembly rRNA – Antibody Affinity Binding Chamber Selective Filters Sample Injector (Retractable) Lysis Chamber Sample Reservoir Saline Lysis Solution 2/26/2014 © 2014 Immunotrex Biologics 25 Mosaic 545™ Pathogen Diagnostic Technology Platform Blood Sample Components White Blood Cells (7-20 µm) Decreasing Size Red Blood Cells (6-8 µm) Bacteria (3-10µm) Ribosomes, Proteins (<1 µm) Nucleic Acids (nm) (Images not to scale) 2/26/2014 © 2014 Immunotrex Biologics 26 Mosaic 545™ Pathogen Diagnostic Technology Platform Intra-Cartridge Specimen Processing Within the Pathogen Identification cartridge: 1) The specimen is filtered, excluding components > 10µm; bacteria pass through the filter. 2) The pathogenic bacteria are lysed, releasing cellular components, including targeted ribosomal RNAs (rRNAs). 3) The specimen is filtered, removing lysis debris >1µm; proteins, ribosomes and nucleic acids pass through the filter. 4) Specimen rRNAs are exposed to multiple reduced graphene oxide (RGO) sensors, each coated with a unique specific affinity monoclonal antibody. 10 µm Filter Target rRNA 2/26/2014 © 2014 Immunotrex Biologics 27 Mosaic 545™ Pathogen Diagnostic Technology Platform Intra-Cartridge Specimen Processing Within the Pathogen Identification cartridge: 1) The specimen is filtered, excluding components > 10µm; bacteria pass through the filter. 2) The pathogenic bacteria are lysed, releasing cellular components, including targeted ribosomal RNAs (rRNAs). 3) The specimen is filtered, removing lysis debris >1µm; proteins, ribosomes and nucleic acids pass through the filter. 4) Specimen rRNAs are exposed to multiple reduced graphene oxide (RGO) sensors, each coated with a unique specific affinity monoclonal antibody. < 1 µm Filter Target rRNA 10 µm Filter 2/26/2014 © 2014 Immunotrex Biologics 28 Mosaic 545™ Pathogen Diagnostic Technology Platform Intra-Cartridge Specimen Processing Within the Pathogen Identification cartridge: Target rRNA 1) The specimen is filtered, excluding components > 10µm; bacteria pass through the filter. 2) The pathogenic bacteria are lysed, releasing cellular components, including targeted ribosomal RNAs (rRNAs). 3) The specimen is filtered, removing lysis debris > 1µm; proteins, ribosomes and nucleic acids pass through the filter. 4) Specimen rRNAs are exposed to multiple reduced graphene oxide (RGO) sensors, each coated with a unique specific affinity monoclonal antibody. < 1 µm Filter Ribosome Protein 2/26/2014 © 2014 Immunotrex Biologics 29 Mosaic 545™ Pathogen Diagnostic Technology Platform Intra-Cartridge Specimen Processing Within the Pathogen Identification cartridge: 1) The specimen is filtered, excluding components > 10µm; bacteria pass through the filter. 2) The pathogenic bacteria are lysed, releasing cellular components, including targeted ribosomal RNAs (rRNAs). 3) The specimen is filtered, removing lysis debris > 1µm; proteins, ribosomes and nucleic acids pass through the filter. 4) Specimen rRNAs are exposed to multiple reduced graphene oxide (RGO) sensors, each coated with a unique specific affinity monoclonal antibody. Target rRNA Nucleic Acids 2/26/2014 © 2014 Immunotrex Biologics 30 Mosaic 545™ Pathogen Diagnostic Technology Platform Intra-Cartridge Specimen Processing Within the Pathogen Identification cartridge: Target rRNA 2/26/2014 1) The specimen is filtered, excluding components > 10µm; bacteria pass through the filter. 2) The pathogenic bacteria are lysed, releasing cellular components, including targeted ribosomal RNAs (rRNAs). 3) The specimen is filtered, removing lysis debris > 1µm; proteins, ribosomes and nucleic acids pass through the filter. 4) Specimen rRNAs are exposed to multiple reduced graphene oxide (RGO) sensors, each coated with a unique specific affinity monoclonal antibody. mAb binds target rRNA © 2014 Immunotrex Biologics 31 MOSAIC 545™ PROTOTYPE DESIGN 2/26/2014 © 2014 Immunotrex Biologics 32 Mosaic 545™ Pathogen Diagnostic Technology Platform Bacterial Pathogens Nominal Size Bacterial Pathogen Bartonella henselae 0.5 1.0 Borrelia burgdorferi 0.2 – 0.3 10 - 30 Brucella (species) 0.6 - 1.5 2 - 10 0.5 -- Clostridium botulinum 0.3 - 1.9 2 - 10 Clostridium perfringens 0.5 - 5.0 5 Cryptosporidium parvum 4.2 - 6.5 4.5 - 7.9 Escherichia coli O157:H7 0.25 - 1.0 3.0 Rickettsia prowazekii 0.3 1.0 Salmonella (species) 0.3 3 Shigella dysentariae 0.4 - 0.6 1.0 - 3.0 Staphylococcus aureus 0.5 - 0.8 -- 0.5 – 1.25 -- 1.0 2-3 Chlamydia psittaci Electron micrograph - S. aureus, the strain responsible for MRSA Streptococcus pneumoniae Vibrio cholerae 2/26/2014 Diameter (µ) Length (µ) © 2014 Immunotrex Biologics 33 Mosaic 545™ Pathogen Diagnostic Technology Platform Sensor Function The baseline impedance of each sensor is established prior to sample processing. At this point, the specimen is intact, and no antibody binding has occurred. The Mosaic 545 monitors the impedance across each sensor continuously in real-time, detecting and identifying changes resulting from antibody-pathogen binding. Localized sensor fluorescence is measured, confirming binding interaction at the sensor. 2/26/2014 © 2014 Immunotrex Biologics 34 Mosaic 545™ Pathogen Diagnostic Technology Platform Bimodal Sensor Assembly Impedance Sensor Fluorescence Sensor mAb-coated RGO Targeted rRNA binding increases electrical impedance through mAb-coated reduced graphene oxide (RGO) sensor. Fluorophore emission from rRNA-mAB binding confirms impedance sensor identification of pathogen. Resonant frequency 2/26/2014 Change in resonance due to introduction of pathogen © 2014 Immunotrex Biologics 35 Mosaic 545™ Pathogen Diagnostic Technology Platform Impedance Sensor Nucleic Acids (+) Target rRNA Monoclonal Antibody (-) mAb + rRNA mAb-coated RGO (Reduced Graphene Oxide) 2/26/2014 © 2014 Immunotrex Biologics 36 Mosaic 545™ Pathogen Diagnostic Technology Platform Fluorescence Sensor Fluorescence (+) Target rRNA Monoclonal Antibody (-) mAb + rRNA mAb-coated RGO (Reduced Graphene Oxide) 2/26/2014 © 2014 Immunotrex Biologics 37 Mosaic 545™ Cartridge – BARDA Pathogen Profile CTRL 1. 2. 3. 4. 5. 6. 7. Clostridium botulinum Brucella (species) Clostridium perfringens Salmonella (species) Escherichia coli O157:H7 Shigella dysentariae Chlamydia psittaci 2/26/2014 1 8 2 9 3 10 4 11 5 12 6 13 7 14 © 2014 Immunotrex Biologics 8. 9. 10. 11. 12. 13. 14. Staphylococcus aureus Rickettsia prowazekii Vibrio cholerae Cryptosporidium parvum Bartonella henselae Borrelia burgdorferi Streptococcus pneumoniae 38 Mosaic 545™ Pathogen Diagnostic Technology Platform Multi-Slot Cartridge Reader “Plug and play”—Technician inserts cartridge(s) into Mosaic 545 card reader and initiates the processing run. Cartridge is validated prior to processing specimen. Current design offers 12 cartridge slots — processes up to 12 samples simultaneously, in < 10 minutes. Bar code reader syncs test result to patient. Multiple data transmission options—to PC, wireless network, Radio Frequency Identification (RFID), onboard LCD display, Short Message Service (SHS), Multimedia Messaging Service (MMS) 2/26/2014 © 2014 Immunotrex Biologics 39 Mosaic 545™ Pathogen Diagnostic Technology Platform Signal Processing Software Mosaic 545 combines well established scientific elements with cutting edge technologies to identify the presence of pathogens at a sub-specific (strain) level. The mechanism of detection is two-fold: I. Change in impedance across a reduced graphene oxide (RGO) sensor II. Optical measurement of fluorescence emission Changes are due to specific ribosomal RNA (rRNA) – monoclonal antibody (mAb) binding. The sensor array is coded and activated sensor(s) identify the pathogen(s). 2/26/2014 © 2014 Immunotrex Biologics 40 Traditional Culture vs. Mosaic 545 Features Traditional Culture Methods Mosaic 545™ Speed 24 – 48 hours 5 – 10 minutes Safety Incubation, growth, and handling of specimen pathogen; complex disposal process Specimen pathogen quarantined and destroyed; simple disposal of cartridge Simplicity Multi-step protocol Unitary cartridge processing 2/26/2014 © 2014 Immunotrex Biologics 41 Mosaic 545™ Pathogen Diagnostic Technology Platform Contract Manufacturing Associates Immunotrex has pending proposals from two contract manufacturing firms: Enercon Technologies, Inc. for development of the Mosaic 545 cartridge and multi-bay reader Precision Antibodies, Inc. for custom monoclonal antibodies Submitted proposals include pilot program development through to multiple working prototypes for internal and external testing. Time to completion of prototype – 6 months from project initiation. Immunotrex maintains all rights to any and all contracted works. Enercon Technologies, Inc. – Gray, ME ISO 13485:2003 FDA Registered 21 CFR Part 820 GMP ISO 9001:2008 ESD S20.20 UL, ETL, TUV 2/26/2014 Precision Antibody™, Inc. – Columbia, MD AAALAC accredited Custom mAb development “One Stop Shop” FDA, NCI, EPA contractor © 2014 Immunotrex Biologics 42 Mosaic 545™ Pathogen Diagnostic Technology Platform Intellectual Property • US Patent Application Serial No. 13/894,971 (Newly Filed) • Continuation Application of USSN 12/426,470 • Title: METHODS FOR MICROORGANISM DETECTION AND IDENTIFICATION • M&G Ref: 40819.0001USC3 2/26/2014 © 2014 Immunotrex Biologics 43 Mosaic 545™ Pathogen Diagnostic Technology Platform Thank You Immunotrex Biologics appreciates the opportunity to present our Mosaic 545™ pathogen diagnostic technology platform. Questions ? 2/26/2014 © 2014 Immunotrex Biologics 44
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