Coronado Corporate Presentation - September 2011 Rodman and Renshaw Conference
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Coronado Corporate Presentation - September 2011 Rodman and Renshaw Conference

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Coronado Biosciences is engaged in the development of novel immunotherapy biologic agents. The Company's two principal pharmaceutical product candidates in clinical development are: CNDO-201, a ...

Coronado Biosciences is engaged in the development of novel immunotherapy biologic agents. The Company's two principal pharmaceutical product candidates in clinical development are: CNDO-201, a biologic for the treatment of autoimmune diseases, such as Crohn's disease, ulcerative colitis and multiple sclerosis; and CNDO-109, a biologic that activates natural killer cells, for the treatment of acute myeloid leukemia and solid tumors.

The Company recently completed a $25.8 million round of financing and is using the proceeds to advance its pipeline, including funding Phase II double-blind, placebo controlled trial of CNDO-201 for the treatment of Crohn's Disease scheduled for initiation in early 2012 and a Phase I/II dose escalation and expansion trial of CNDO-109 for the treatment of relapsed Acute Myeloid Leukemia (AML) planned for 2012. Each of these drugs is a novel therapy that has achieved clinical proof-of-concept in indications with unmet medical needs.

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Coronado Corporate Presentation - September 2011 Rodman and Renshaw Conference Coronado Corporate Presentation - September 2011 Rodman and Renshaw Conference Presentation Transcript

  • Coronado BiosciencesCorporate PresentationSeptember 2011
    Bobby W. Sandage, Jr., PhD President & Chief Executive Officer
  • Statements in this presentation that are not descriptions of historical facts are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. We have attempted to identify forward-looking statements by terminology including “anticipates,”“believes,”“can,”“continue,”“could,”“estimates,”“expects,”“intends,”“may,”“plans,”“potential,”“predicts,”“should,” or “will” or the negative of these terms or other comparable terminology. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include those set forth in our Registration Statement on Form 10 including, in particular, risks relating to: the results of research and development activities; uncertainties relating to preclinical and clinical testing, financing and strategic agreements and relationships; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; and competition. We expressly disclaim any obligation or undertaking to update or revise any statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances after the date of this presentation.
    2
    Forward Looking Statements
  • Focused on autoimmune diseases and cancer immunotherapy
    Two biologic product candidates in clinical stage development
    Novel treatment approach with broad therapeutic applications addressing multi-billion dollar markets
    Completed four clinical trials
    CNDO-201: Trichuris suisova (TSO) in Crohn’s Disease, Ulcerative Colitis (UC) and Multiple Sclerosis (MS)
    CNDO-109: Tumor Activated NK Cells in relapsed Acute Myeloid Leukemia (AML)
    Strong proprietary property position
    Experienced management team and board of directors
    3
    Company and Product Highlights
  • CNDO-201 (TSO)
    Compound & Indication Preclinical Phase I Phase IIa Phase IIb
    Crohn’s Disease
    Coronado Biosciences Pipeline
    Initiate P2 1Q 2012
    Ulcerative Colitis
    Multiple Sclerosis
    CNDO-109 (Tumor Activated NK Cells)
    Compound & Indication Preclinical Phase I Phase IIa Phase IIb
    Relapsed AML
    Initiate P 1/2 2012
    Multiple Myeloma
    Solid Tumors
    4
  • Porcine whipworm ova
    Represents a novel approach to treating autoimmune diseases – the “Hygiene Hypothesis”
    Natural immunomodulator - regulates T-Cells (Th1 and Th2) and inflammatory cytokines
    Proof of principle established in inflammatory bowel disease and MS
    Natural properties suggest strong potential for a safe profile – not associated with risks of immunosuppressant drugs
    Oral bi-weekly administration
    Initial indications have well established clinical trial pathways
    North and South America and Japanese rights for all indications from OvaMed
    5
    CNDO-201: Trichuris suisova (TSO)
    European rights to TSO for GI indications have been license to Dr. Falk Pharma, who has initiated a Phase II trial in Crohn’s Disease
  • 6
    Rapid Emergence of Immune-Related Diseases
    Bach NEJM 2002
  • 7
    Distribution of Autoimmune Disorders and Helminths
    Autoimmune disorders incidence
    Helminths infestation incidence
    High
    High
    Moderate
    Moderate
    Low
    Low
    Epidemiological data demonstrate:
    Various immunological and autoimmune diseases are much less common in the developing world than the industrialized world
    Immigrants to the industrialized world from the developing world increasingly develop immunological disorders in relation to the length of time since arrival in the industrialized world
  • The Hygiene Hypothesis
    Viral, bacterial and protozoan infections
    Excess
    Th1
    Crohn’s Disease, Ulcerative Colitis, Multiple Sclerosis & other autoimmune diseases
    GENETIC PREDISPOSITION
    POOR SANITATION,IMPURE FOOD
    AND CROWDED LIVING CONDITIONS
    The developing immune system must receive stimuli from infectious agents, symbiotic bacteria or parasites in order to adequately develop regulatory T-cells. Otherwise, it will be more susceptible to autoimmune diseases resulting from insufficiently balanced Th1 and Th2 responses
    Helminthic and bacterial exposures
    Immune Regulation
    Inhibits
    Excess
    Reactivity
    (Prevents)
    (Weinstock and Elliott, Inflamm Bowel Dis, Jan 2009)
    8
    • Does not multiply in human host
    • Colonization is self-limited in humans
    • No systemic phase
    • No direct transmission
    • Ova stable
    9
    Benefits of Trichuris suis ova (TSO)
  • 10
    Effect of TSO in Crohn’s Disease Patients
    79.3
    75.9
    72.4
    62.1
    Summers, et.al., GUT 2005
  • 11
    Effect of TSO in Ulcerative Colitis Patients
    % of Patients Achieving a Response
    44.8
    P=0.04
    43.3
    P=0.04
    17.4
    16.7
    Summers, et.al., Gastroenterology 2005
  • 2H 2011
    File IND with U.S. FDA
    Phase I dose escalation study
    36 Crohn's disease patients (3 placebo and 9 treated per cohort)
    500, 2500 and 7500 TSO single dose
    Dose escalated every 2 weeks
    Results- December 2011
    1Q 2012
    Initiate Phase II Crohn’s Study in U.S.
    12
    Next Steps for TSO in IBD
  • The Impact of Parasitic Infections on the Course of Multiple Sclerosis
    Antihelminth
    Treatment
    (n=4)
    Antihelminth
    Treatment
    (n=4)
    12 patients/group
    Correale J, Farez MF. J Neuroimmunol. 2011;233:6
  • 14
    Effect of TSO in Multiple Sclerosis Patients
    Fleming, et.al., Multiple Sclerosis Journal 2011
  • HINT 2 (open label)
    Enrolling 18 subjects
    2500 Trichuris suis ova every 2 weeks for 10 months
    University of Wisconsin
    Top-line data expected in 2H2012
    TRIMS A (open label)
    Enrolled 10 patients
    2500 Trichuris suis ova every 2 weeks for 12 weeks
    Rigshospitalet, Danish Multiple Sclerosis Research Center
    Abstract presentation October 2011
    TRIMS B (double-blind placebo controlled)
    To enroll 80 patients
    2500 Trichuris suis ova every 2 weeks for 12 months
    Rigshospitalet, Danish Multiple Sclerosis Research Center
    Enrollment initiation targeted for 4Q2011
    15
    On-going Investigator Sponsored Trials in MS
  • NK cells represent the key component of the body’s innate immune surveillance system
    Safe, effective activation of these NK cells in cancer patients remain a long sought after goal in oncology therapy
    Membrane lysate preparation (CNDO-109) derived from a well characterized lymphoblastic leukemia cell line (CTV-1)
    Primes NK cells without triggering NK-mediated lysing
    Activation with CNDO-109 does not require toxic cytokines or long-term culture/expansion, and does not change NK cell phenotypes
    Proof of principle established in patients with high-risk refractory or relapsed acute myeloid leukemia (AML)
    Preclinical activity demonstrated in multiple myeloma, breast cancer, prostate cancer and ovarian cancer
    Continuing to evaluate other tumor types
    16
    CNDO-109: Activated Natural Killer Cells
  • 17
    CNDO-109 Mechanism of Action
    CNDO-109
    Priming
    signal
    Resting
    Donor NK
    Primed
    Donor NK
    Primed
    Donor NK
    Priming
    receptor
    Trigger
    receptor
    Priming – Signal 1
    Activated ex vivo by CTV-1
    Effective from autologous or allogeneic NK cell source
    Easier to make, more potent, and durable than cytokine (IL-2) primed NK cells
    Uniquely positioned in patients with “minimal residual disease”
    Remains active after freeze/thaw
    Patient’s
    tumor
    Triggering – Signal 2
    Priming
    receptor
    Trigger
    receptor
    Trigger
    ligand
    Tumor lysis
    “Serial Killer”
    Dead
    Tumor
    cell
    Priming
    receptor
    Trigger
    receptor
  • Phase I investigator sponsored open-label trial
    To determine the safety of infusion of allogeneic Tumor-activated NK (TaNK) cells after low dose radiotherapy plus chemotherapy in in high-risk relapse or refractory AML patients
    Enrolled 7 AML patients in complete remission (CR) following multiple relapses and/or high-risk
    18
    CNDO-109 Phase I Study in AML
  • Final Phase I UK clinical trial results reported in 4Q2011
    File IND in U.S. in early 2012
    Initiate Phase 1/2 allogeneic clinical trial for the treatment of relapsed AML
    Potential for regulatory approval with single randomized, controlled clinical trial if data are clinically meaningful and statistically persuasive
    Once the dose is selected, initiate a randomized phase 2 trial
    Future autologous studies planned in other tumor types (including multiple myeloma, breast, ovarian and prostate)
    19
    CNDO-109 Next Steps
  • Bobby W. Sandage, Jr., PhD – President & Chief Executive Officer
    Served as EVP and CSO of Indevus Pharmaceuticals, Inc.
    Over 30 years of pharmaceutical/biotechnology experience
    Glenn L. Cooper, MD – Executive Chairman
    Served as Chairman and Chief Executive Officer of Indevus Pharmaceuticals, Inc.
    Over 25 years of Pharmaceutical/Biotechnology experience
    Eric K. Rowinsky, MD – Vice Chairman
    World renown oncologist, former CMO at ImClone, board of Biogen/Idec
    Over 25 years of Healthcare experience
    Lindsay Rosenwald, MD – Director and Founder
    A prolific and successful investor in the Life Sciences industry for over 20 years
    One of his start-up companies, Cougar Biotechnology, was recently acquired last year for $1 billion (all cash) by Johnson and Johnson, a record for a company with only Phase 2 data (oncology)
    20
    Key Management and Board Members
    • Investment to-date $65M
    • Shares Outstanding 18,524,245
    • Cash Position $29M
    • Filed Form 10 to become July 15, 2011
    public reporting company
    • Trading on Major ExchangeDecember 2011
    21
    Financialsas of 7/15/2011
  • CNDO-201
    File IND submission 3Q 2011
    Report results from Phase I safety study 4Q 2011
    Report additional Phase 1 MS data 4Q 2011
    Initiate Phase 2b Crohn’s trial 1Q 2012
    CNDO-109
    Report final Phase 1 data in AML 4Q 2011
    Complete IND-enabling CMC 4Q 2011
    File IND submission 1Q 2012
    Initiate US Phase 1/2 Study 1H 2012
    22
    Upcoming Milestones
  • Focused on autoimmune diseases and cancer immunotherapy
    Two biologic product candidates in clinical stage development
    Novel treatment approach with broad therapeutic applications addressing multi-billion dollar markets
    Completed four clinical trials
    CNDO-201: Trichuris suisova (TSO) in Crohn’s Disease, Ulcerative Colitis (UC) and Multiple Sclerosis (MS)
    CNDO-109: Tumor Activated NK Cells in relapsed Acute Myeloid Leukemia (AML)
    Strong proprietary property position
    Experienced management team and board of directors
    23
    Investment Highlights