Nucleic Acid Chemistry for a New Generation of Pharmaceuticals Corporate Presentation Confidential
Spring Bank Corporate Vision <ul><li>Utilize our proprietary nucleic acid chemistry platform to design and develop molecul...
Investor Overview <ul><li>Breakthrough nucleic acid based therapeutic platform </li></ul><ul><ul><li>Orally bio-available ...
Spring Bank Corporate Overview <ul><li>Founded in 2002 </li></ul><ul><li>Proprietary nucleotide-based therapeutic platform...
Spring Bank Platform Allows for Multiple Points of Influence <ul><li>Proteins are key to almost all biological functions <...
Spring Bank Technology Platform Applicable to a Wide Range of Therapeutic Targets <ul><li>Proprietary nucleic acid chemist...
Spring Bank Technology Platform – Strong Competitive Advantages Nucleoside/Nucleotide Analogs Immune Modulators RNAi/Antis...
Urgent Need for New Hepatitis Therapies <ul><li>HBV </li></ul><ul><ul><li>1/3 world population (2+ billion) infected </li>...
Chronic HBV is a Global Health Problem: 350–400 Million Infected >8% High 2–7% Intermediate <2% Low Source:  World Health ...
SB 9000 Target Indication: Hepatitis B <ul><li>Hepatitis –  </li></ul><ul><ul><li>Liver is host to Hepatitis B virus, and ...
SB 9000 Demonstrates Anti-HBV Activity in 14 Day Transgenic Mouse Model <ul><li>Initial high-dose study </li></ul><ul><li>...
SB 9000 Demonstrates Potent Suppression of Liver HBV DNA in 14 Day Transgenic Mouse Model <ul><li>Southern blot analysis o...
Oral SB 9000 Prodrug Shows Potent Antiviral Activity  in 14-Day Transgenic Mouse Model Southern Blot Analysis  of Liver HB...
SB 9200 Target Indication: Hepatitis C <ul><li>Hepatitis –  </li></ul><ul><ul><li>Liver is host to Hepatitis C viruses, an...
In Vitro and In Vivo Safety Studies of SB 9200 <ul><li>Has CC 50  > 1000 uM in a panel of cell lines including bone marrow...
SB 9200 Shows Potent Anti-HCV Activity In Vitro * Replicon cell line containing H/FL-Neo (genotype 1a (H77), full length c...
SB 9200 Has Demonstrated Synergy with Several Drug Combinations in Vitro 1 1 In collaboration with Brent Korba, Georgetown...
Strategic Plan for Value Creation <ul><li>Build world class management and scientific teams, establish relationships with ...
Management Douglas Jensen Co-founder & CEO Co-founder and CEO, Origenix Technologies VP Administration & Corporate Develop...
Investment Highlights <ul><li>Patented nucleic acid platform technology with wide range of potential disease targets </li>...
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Spring Bank Presentation Jan 09

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New Deliver system for Hep C medication, Im currently consulting with this company on the detoxification testing our labs offers

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  • We have described our company as the Nucleotide Company because we have created a unique drug discovery platform that is focused exclusively on the discovery and development of novel small molecule drugs based on nucleotide chemistry. Platform produces a totally new class of natural–like nucleotide compounds that inherently have many desirable characteristics. Effective for targeting disease, non-toxic, multiple routes of administration including oral and can be designed for treatment of multiple therapeutic indications such as Our internal focus initially on the development of new class of drugs for the treatment of Hepatitis B &amp; C and we have drug candidates in late stage preclinical development for both indications. Excellent Preclinical Results. Very potent against wild type and resistant strains of these viruses, non-toxic up to very high doses, can be used safely and effectively with other classes of drugs NIH has committed $7 million very strong validation of our app
  • We have described our company as the Nucleotide Company because we have pioneered a unique drug discovery platform that is focused exclusively on the discovery and development of novel small molecule drugs based on nucleotide chemistry. Traditional pharma stayed away from this chemistry difficult, expensive and according to their paradigm not well suited for small molecule therapeutics; can’t be made into oral drugs, manufacturing major challenge, Already met these challenges Platform produces a totally new class of natural–like nucleotide compounds that inherently have many desirable characteristics. Effective for targeting disease, non-toxic, multiple routes of administration including oral and can be designed for treatment of multiple therapeutic indications such as Our internal focus initially on the development of new class of drugs for the treatment of Hepatitis B &amp; C and we have drug candidates in late stage preclinical development for both indications. Excellent Preclinical Results. Very potent against wild type and resistant strains of these viruses, non-toxic up to very high doses, can be used safely and effectively with other classes of drugs NIH has committed $7 million very strong validation of our app
  • How familiar are you with this paradigm? This is natural paradigm that drives all drug discovery and development With this technology platform we have the ability to engineer smart molecules that can target nucleic acids and or proteins involved in the disease process
  • Nucleotide platform produces family of compounds that will have consistent biological properties and superior pharmaceutical attributes regardless of the disease target. Compounds will share similar safety and ADME profiles, for example which will be well characterized and well understood which in turn will reduce development risk, shorten time to market and significantly reduce costs. Naturally occurring nucleotides routinely interact with proteins and nucleic acids in the body to perform a number of important cellular functions such as biochemical reactions, cell signaling and as a source of energy. SBP designs its nucleotide compounds to closely mimic these natural interactions
  • Compared with other classes of drugs for the treatment of HBV, SB 9000 stands out as a unique therapeutic option. Unique mechanism of action Oral delivery Effective against mutant strains Can be used in combinations safely and effectively Non-toxic Because of these features with stand the rigors of long term administration Proprietary manufacturing in place both economical and scalable for commercial application.
  • It is now estimated to be about 375 million patients worldwide who have carried the Hepatitis B surface antigen for 6 months or more and have not yet seroconverted. The areas of greatest endemicity include South East Asia and the Western Pacific and Africa countries around the Mediterranean. There are 2 – 3 million new chronically HBV infected patients each year and 1.3 – 1.5 million of the overall population die each year due to chronic Hep B disease.
  • Platform rich in assets that can be leveraged through partnerships licensing agreements to generate non dilutive revenues – off set risk, create financial stability, leverage value to current stakeholders
  • Why I am qualified to manage the company. Kris’s pedigree in Nucleic acid field – major contributor and innovator in field World class laboratories through NIH relationship
  • Momentum and Validation Partnership model for revenue generation in motion
  • Spring Bank Presentation Jan 09

    1. 1. Nucleic Acid Chemistry for a New Generation of Pharmaceuticals Corporate Presentation Confidential
    2. 2. Spring Bank Corporate Vision <ul><li>Utilize our proprietary nucleic acid chemistry platform to design and develop molecules which closely mimic the bodies’ natural disease signaling pathways resulting in therapies with superior specificity, safety and efficacy in antivirals, autoimmune diseases and cancer </li></ul>
    3. 3. Investor Overview <ul><li>Breakthrough nucleic acid based therapeutic platform </li></ul><ul><ul><li>Orally bio-available , natural-like nucleotides are effective and non-toxic </li></ul></ul><ul><ul><li>Ability to leverage chemistry profile for rapid clinical advancement and low investment </li></ul></ul><ul><li>Multiple therapeutic targets: viruses, autoimmune diseases, cancer </li></ul><ul><li>Initial anti-viral application targets $16 billion worldwide hepatitis market </li></ul><ul><ul><li>Non toxic </li></ul></ul><ul><ul><li>Effective in vitro against known resistant strains </li></ul></ul><ul><ul><li>in vitro synergy data indicates promise for combination therapy use </li></ul></ul><ul><li>Hepatitis programs have made significant preclinical progress towards IND </li></ul><ul><li>NIH validates as “new class” of drugs, has committed $7 million to date </li></ul><ul><li>Technology evaluation in process with major pharmaceutical company </li></ul><ul><li>Exploring development collaborations in Asia </li></ul><ul><li>Seeking Series A financing to build organization and advance programs into humans </li></ul>
    4. 4. Spring Bank Corporate Overview <ul><li>Founded in 2002 </li></ul><ul><li>Proprietary nucleotide-based therapeutic platform </li></ul><ul><ul><li>Orally bio-available , natural-like nucleotides are effective and non-toxic </li></ul></ul><ul><ul><li>Ability to leverage chemistry profile for rapid clinical advancement and low investment </li></ul></ul><ul><li>Proprietary manufacturing technology allows: </li></ul><ul><ul><li>Rapid synthesis of lead compounds for development </li></ul></ul><ul><ul><li>Cost effective commercial scale manufacturing </li></ul></ul><ul><li>Multiple therapeutic targets: Viruses, autoimmune diseases, cancer </li></ul><ul><li>2 candidates in preclinical development </li></ul><ul><ul><li>SB 9000 for Hepatitis B </li></ul></ul><ul><ul><li>SB 9200 for Hepatitis C </li></ul></ul><ul><li>NIH validates as “new class” of Hepatitis drugs, has committed $7 million to date </li></ul><ul><ul><li>Significant preclinical progress funded by NIH </li></ul></ul><ul><li>Initial anti-viral lead candidates (SB 9000, 9200) target $16 billion Hepatitis market </li></ul><ul><ul><li>Non toxic in vitro and in animal models </li></ul></ul><ul><ul><li>Effective in vitro against multiple genotypes </li></ul></ul><ul><ul><li>In vitro synergy data indicates promise for combination therapy use </li></ul></ul>
    5. 5. Spring Bank Platform Allows for Multiple Points of Influence <ul><li>Proteins are key to almost all biological functions </li></ul><ul><li>DNA </li></ul><ul><li>DNA provides the blueprint for protein assembly </li></ul><ul><li>Naturally occurring nucleotides interact with proteins and nucleic acids in the body to perform important cellular functions </li></ul><ul><li>Nucleic acid therapeutics are natural-like and have multiple options/binding targets at the nucleic acid or protein level to interfere with specific disease processes </li></ul>NORMAL PROTEIN RNA Protein
    6. 6. Spring Bank Technology Platform Applicable to a Wide Range of Therapeutic Targets <ul><li>Proprietary nucleic acid chemistry platform produces families of compounds with consistent biological properties and superior pharmaceutical attributes </li></ul><ul><li>Similar safety, ADME and dosing profiles reduces development risks and speeds time to market for follow-on compounds </li></ul><ul><li>Nucleic acid compounds can be designed rationally against well-established molecular targets associated with diseases </li></ul><ul><ul><li>Selectivity - to the target tissue </li></ul></ul><ul><ul><li>Specificity - to the molecular target </li></ul></ul><ul><ul><li>Safety - non-toxic to cells and tissues, ingested and excreted without breaking down </li></ul></ul><ul><li>Proprietary solution phase manufacturing process scalable for commercial quantities </li></ul>
    7. 7. Spring Bank Technology Platform – Strong Competitive Advantages Nucleoside/Nucleotide Analogs Immune Modulators RNAi/Antisense SB 9000 Mechanism of Action Chain terminators –target HBV/HCV polymerase Activate natural immune response Complementary RNA strands bind with viral DNA/RNA Targets viral DNA primer that initiates viral replication Major Drawbacks Viral mutation and resistance/Toxicity Toxicity/Delivery Delivery/Toxicity N/A Delivery Oral Injection Injection Oral Viral mutation/resistance Yes Not known Yes No Combination Therapy Limited Options Required Not known Possible Toxicity Significant Significant Significant Non-toxic, not metabolized by liver Cyt P 450 Long Term Administration No/Toxic No/Toxic No/Toxic Probable Manufacturing Economical/scalable Expensive/difficult Need to develop specialized facility Economical/scalable
    8. 8. Urgent Need for New Hepatitis Therapies <ul><li>HBV </li></ul><ul><ul><li>1/3 world population (2+ billion) infected </li></ul></ul><ul><ul><li>~350 million chronically infected </li></ul></ul><ul><ul><li>1 million deaths per year </li></ul></ul><ul><li>HCV </li></ul><ul><ul><li>4 million+ chronic carriers in the US </li></ul></ul><ul><ul><li>Limited treatment options – interferon plus ribavirin </li></ul></ul><ul><ul><li>170 million chronically infected worldwide </li></ul></ul><ul><li>Hepatocellular Carcinoma (HCC) </li></ul><ul><ul><li>Persistent, chronic HBV and HCV infection responsible for 95% of HCC </li></ul></ul><ul><ul><li>Most common malignant tumor worldwide </li></ul></ul><ul><ul><li>1.2 million new cases every year </li></ul></ul><ul><ul><li>5-year survival rate less than 5% </li></ul></ul><ul><ul><li>15,000 US deaths/year from HCC </li></ul></ul><ul><li>Major NIH initiative under way to develop new Hepatitis therapeutics </li></ul><ul><li>Combinations of oral antiviral therapies will likely be the future gold standard for treatment of Hepatitis </li></ul>
    9. 9. Chronic HBV is a Global Health Problem: 350–400 Million Infected >8% High 2–7% Intermediate <2% Low Source: World Health Organization E. Mediterranean 18.5MM North America 1.5MM Africa 71.9MM Latin America 8.7MM Southeast Asia 69.8MM Western Pacific 181.1MM Europe 22.9MM <ul><li>HBV </li></ul><ul><ul><li>1/3 world population (2+ billion) infected </li></ul></ul><ul><ul><li>~350 million chronically infected </li></ul></ul><ul><ul><li>1 million deaths per year </li></ul></ul><ul><li>HCV </li></ul><ul><ul><li>4 million+ chronic carriers in the US </li></ul></ul><ul><ul><li>Limited treatment options </li></ul></ul><ul><ul><li>170 million chronically infected worldwide </li></ul></ul><ul><ul><li>Progression to cirrhosis, liver cancer </li></ul></ul><ul><li>Hepatocellular Carcinoma (HCC) </li></ul><ul><ul><li>Chronic infection responsible for 95% of HCC </li></ul></ul><ul><ul><li>Most common malignant tumor worldwide </li></ul></ul><ul><ul><li>1.2 million new cases every year </li></ul></ul><ul><ul><li>5-year survival rate less than 5% </li></ul></ul><ul><li>Major NIH initiative under way to develop new Hepatitis therapeutics </li></ul><ul><ul><li>Total CHBV: ~375MM </li></ul></ul><ul><ul><li>Annual New Inf.: 2–3MM </li></ul></ul><ul><ul><li>Annual Deaths: 1.3–1.5MM </li></ul></ul>2003
    10. 10. SB 9000 Target Indication: Hepatitis B <ul><li>Hepatitis – </li></ul><ul><ul><li>Liver is host to Hepatitis B virus, and is target organ for therapy </li></ul></ul><ul><ul><li>Disease progression leads to liver failure, hepatocellular carcinoma </li></ul></ul><ul><ul><li>Liver transplants become re-infected </li></ul></ul><ul><li>Limited effectiveness of existing therapeutics </li></ul><ul><ul><li>Resistance </li></ul></ul><ul><ul><li>Chain terminator mechanism of action leads to non-specific host toxicity </li></ul></ul><ul><ul><li>Competitive drugs need to be metabolized by the liver to become active, leading to toxicity and limiting dosage </li></ul></ul><ul><li>SB 9000 is an excellent anti-viral candidate </li></ul><ul><ul><li>Oral bioavailability </li></ul></ul><ul><ul><li>Non-toxic </li></ul></ul><ul><ul><li>Not metabolized by the liver ( CytP 450 ) </li></ul></ul><ul><ul><li>Synergy with other classes of antivirals may allow for combination therapy with SB 9000 </li></ul></ul><ul><ul><li>In vitro activity against all known resistance mutations for HBV </li></ul></ul>
    11. 11. SB 9000 Demonstrates Anti-HBV Activity in 14 Day Transgenic Mouse Model <ul><li>Initial high-dose study </li></ul><ul><li>Dose response study </li></ul><ul><li>EC 50 of SB 9000 is <1 mg/Kg </li></ul><ul><li>More potent than Adefovir </li></ul><ul><li>14-day daily administration </li></ul><ul><li>IP route </li></ul><ul><li>SB 9000 safe at 100 mg/Kg </li></ul><ul><li>Adefovir 10 mg/Kg </li></ul><ul><li>Quantitative PCR and Southern blot analysis </li></ul><ul><li>Near-complete absence of liver HBV DNA by day 14 </li></ul>**P < 0.05, ***P < 0.001
    12. 12. SB 9000 Demonstrates Potent Suppression of Liver HBV DNA in 14 Day Transgenic Mouse Model <ul><li>Southern blot analysis of liver HBV DNA following 14-day treatment </li></ul><ul><li>No treatment-associated toxicity with SB 9000 </li></ul>SB 9000 in CES Adefovir in CES CES (control) SB 9000 in Saline Saline (control)
    13. 13. Oral SB 9000 Prodrug Shows Potent Antiviral Activity in 14-Day Transgenic Mouse Model Southern Blot Analysis of Liver HBV DNA Treated Control EC 50 < 3mg/Kg
    14. 14. SB 9200 Target Indication: Hepatitis C <ul><li>Hepatitis – </li></ul><ul><ul><li>Liver is host to Hepatitis C viruses, and is target organ for therapy </li></ul></ul><ul><ul><li>Disease progression leads to liver failure, hepatocellular carcinoma </li></ul></ul><ul><ul><li>Liver transplants become re-infected </li></ul></ul><ul><li>Limited effectiveness of existing therapeutics </li></ul><ul><ul><li>Resistance </li></ul></ul><ul><ul><li>Chain terminator mechanism of action leads to non-specific host toxicity </li></ul></ul><ul><ul><li>Competitive drugs need to be metabolized by the liver to become active, leading to toxicity and limiting dosage </li></ul></ul><ul><li>SB 9200 is an excellent anti-viral candidate for HCV </li></ul><ul><ul><li>Oral bioavailability </li></ul></ul><ul><ul><li>Non-toxic </li></ul></ul><ul><ul><li>Not metabolized by the liver ( CytP 450 ) </li></ul></ul><ul><ul><li>Synergy with other classes of antivirals may allow for combination therapy with SB 9200 </li></ul></ul>
    15. 15. In Vitro and In Vivo Safety Studies of SB 9200 <ul><li>Has CC 50 > 1000 uM in a panel of cell lines including bone marrow (HFF), kidney (MDBK), Hep G2.2.15 (liver) and PBMC </li></ul><ul><li>No evidence of toxicity in mice in dose-ranging studies up to 300 mg/kg/day by oral administration for 14 days </li></ul><ul><li>No evidence of toxicity in dose-ranging studies in rats by oral administration at 1g/kg/day for 7 days </li></ul><ul><li>Non mutagenic in the Ames assay at high doses </li></ul>
    16. 16. SB 9200 Shows Potent Anti-HCV Activity In Vitro * Replicon cell line containing H/FL-Neo (genotype 1a (H77), full length construct) (Blight, et al., 2003, J. Virol. 77:3181) **Replicon cell line AVA5 (sub-genomic (CON1), genotype 1b; (Blight, et al., 2000, Science 290:1972) EC 50 and EC 90 are drug concentrations which results in a 2-fold, or a 10-fold depression of intracellular HCV RNA relative to that of the untreated controls [ Dot blot hybridization assay normalized to b-actin RNA]. Inhibition of HCV Replication Using the Replicon Assay Viral Genotype Compound 1A* 1B** EC 50 EC 90 EC 50 EC 90 micromolar micromolar SB 9200 2.2 8 1 6 SB 9400 NA NA 0.16 NA SB 9300 2.9 8.5 3.2 NA Interferon (alFNB2) U/mL 1.8 8.0 2 8.5 2C Me Cyt (NM 283) 1.6 6.2 NA NA
    17. 17. SB 9200 Has Demonstrated Synergy with Several Drug Combinations in Vitro 1 1 In collaboration with Brent Korba, Georgetown University Drug EC 50 (uM) Ratio EC 50 Comb (uM) Comments SB 9200 1.5 - 2.3 +Interferon α 2.1 3:1 1:1 1:3 0.662 0.643 0.658 Synergistic Synergistic Synergistic +Ribavirin >30 1:30 2.3 Synergistic +Ribavirin + interferon α 3:1 1:1 1:3 0.777 0.629 0.686 Synergistic Synergistic Synergistic + 2C Me Cyt (NM 283) 1.4 3:1 1:1 1:3 0.522 0.494 0.462 Synergistic Synergistic Additive +Vertex (telaprevir) 0.250 (CC 50 <80) 100:1 30:1 10:1 0.108 0.126 0.118 Synergistic Synergistic Synergistic
    18. 18. Strategic Plan for Value Creation <ul><li>Build world class management and scientific teams, establish relationships with key international opinion leaders </li></ul><ul><li>Advance key development programs through Phase IIa proof of concept </li></ul><ul><ul><li>Phase IIa endpoint (demonstration of reduction in viral load) maximizes partnership value </li></ul></ul><ul><li>Establish partnerships to generate non-dilutive capital and reduce risk </li></ul><ul><ul><li>Development and commercialization partnerships </li></ul></ul><ul><ul><li>Research collaborations in autoimmune diseases and cancer </li></ul></ul><ul><ul><li>Product, discovery platform and manufacturing technology licensing </li></ul></ul><ul><li>Leverage technology platform to build pipeline of new drugs for high value disease targets </li></ul>
    19. 19. Management Douglas Jensen Co-founder & CEO Co-founder and CEO, Origenix Technologies VP Administration & Corporate Development, Hybridon Sr. VP Oppenheimer & Company R.P. (Kris) Iyer, Ph.D. Co-founder & CSO Co-founder & VP Discovery, Origenix Senior Scientist & Associate Director of the Discovery Program and Technology Development, Hybridon Don Mitchell, MBA VP Corporate Development, CCO Exec Director, Corp Development, Idenix Pharmaceuticals Director of Marketing/Strategic Planning, Amgen Principal Consultant, PricewaterhouseCoopers Director, Marketing/Business Development, Novartis Academic Collaborators Professor Brent Korba, Ph.D. Georgetown University (HBV, HCV) Professor John Morrey, Ph.D. Utah State University (HBV) Professor Nigel Bourne, Ph.D. University of Texas (HCV) Professor Norman Kneteman, Ph.D. University of Alberta, KMT Hepatech
    20. 20. Investment Highlights <ul><li>Patented nucleic acid platform technology with wide range of potential disease targets </li></ul><ul><li>Clinical candidates SB 9000, 9200 demonstrate excellent safety and efficacy profiles in preclinical studies </li></ul><ul><ul><li>Orally bioavailable </li></ul></ul><ul><ul><li>Non-toxic </li></ul></ul><ul><ul><li>Potential for use in combination therapy </li></ul></ul><ul><ul><li>Effective against multiple genotypes </li></ul></ul><ul><li>$7 million NIH support to date validates “first-in-class” therapeutic platform and need for new approach to hepatitis </li></ul><ul><li>Technology evaluation in process with major pharmaceutical company </li></ul><ul><li>Exploring development collaborations in Asia </li></ul><ul><li>Seeking Series A financing to build organization and advance programs into humans </li></ul>

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