We think you have liked this presentation. If you wish to download it, please recommend it to your friends in any social system. Share buttons are a little bit lower. Thank you!
Presentation is loading. Please wait.
Published byErin Madden
Modified about 1 year ago
© 2011 Idera Pharmaceuticalswww.iderapharma.com 1 © 2011 Idera Pharmaceuticalswww.iderapharma.com 1 Clinical Pipeline Discovery Platform + Nasdaq: IDRA Translational Research May 2011 Lou Arcudi, Chief Financial Officer Noble Financial Capital Market’s Seventh Annual Equity Conference
© 2011 Idera Pharmaceuticalswww.iderapharma.com 2 Safe Harbor Statement Any statements that we may make in this presentation about future expectations, plans and prospects for the Company constitute forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks as to whether results obtained in preclinical studies or early clinical trials will be indicative of results obtained in future studies or trials; whether products based on Idera’s technology will advance through the clinical trial process and receive regulatory approval on a timely basis or at all; whether, if such products receive approval, they will be successfully distributed and marketed; whether the Company’s collaborations will result in successful product development and in the Company receiving payments thereunder; whether the patent and patent applications owned or licensed by Idera will protect the Company's technology and prevent others from infringing it; whether Idera's cash resources will be sufficient to fund product development and other operations; and such other important factors as are set forth under the caption "Risk Factors" in Idera’s Quarterly Report on Form 10Q for the three months ended March 31, 2011. Idera disclaims any intention or obligation to update any forward-looking statements.
© 2011 Idera Pharmaceuticalswww.iderapharma.com 3 Idera: Clinical Stage Development Company Diverse clinical-stage pipeline of proprietary and partnered drug candidates targeting Toll-like receptors (TLRs) Clinical data validating scientific rationale in Oncology, Chronic Hepatitis C Virus Infection, and Autoimmune Diseases In 2011, multiple clinical programs in Phase 2 Entire development portfolio generated by Idera’s chemistry-based TLR drug discovery capability Strong patent position, over 500 patents in portfolio
© 2011 Idera Pharmaceuticalswww.iderapharma.com 4 Idera’s Pipeline of Candidates PRECLINICALPHASE 1PHASE 2PHASE 3 Oncology IMO-2055 (EMD 1201081) Head and Neck, Second-line Other Cancer Indications Hepatitis C IMO-2125 Null-responder patients Treatment-naïve patients Autoimmune Diseases IMO-3100 Healthy Subjects Lupus, Rheumatoid Arthritis, Psoriasis Hyperlipidemia Respiratory Disease IMO-2134 Healthy Subjects Hematological Malignancies IMO-4200 Vaccine Adjuvants TLR7, 8 and 9 Agonists Cancer, Infectious Diseases, Alzheimer’s Disease TLR3 Agonists COLLABORATION WITH
© 2011 Idera Pharmaceuticalswww.iderapharma.com 5 Idera’s TLR-Targeted Candidates Chemistry Drug Candidates IMO-2055 IMO-2125 IMO-3100 IMO-2134 IMO-4200 IMO-5001 IMO-2311 IMO-2314 IMO-2295 mDCs pDCs B cells Macrophages/ Monocytes NK Cells TLR Signaling Endosome Cytoplasm Nucleus
© 2011 Idera Pharmaceuticalswww.iderapharma.com 6 IMO-2055: for the Treatment of Cancer IMO-2055, a TLR9 agonist, induces innate and adaptive immune responses IMO-2055 shows anticancer activity in multiple preclinical tumor models IMO-2055 potentiates anticancer activity of Erbitux ® in preclinical tumor models Mechanism of action of IMO-2055 provides a rationale for targeted immunotherapy of cancer Antitumor Activity B cellspDCs IMO-2055 Enhanced antitumor activity Th1-type immune responses NK Cell Activation Erbitux ®
© 2011 Idera Pharmaceuticalswww.iderapharma.com 7 IMO-2055: Collaboration with Merck KGaA Entered into collaboration with Merck KGaA in December 2007 for discovery and development of TLR9 agonists for cancer treatment Business terms $40M upfront payments received Total potential milestones remaining €255M Commercialization royalties: mid-single digit escalating to low-double digit R&D costs covered by Merck KGaA Milestone Payments Received $12M associated with initiation of three trials Merck KGaA is conducting clinical trials of IMO-2055 (EMD 1201081) in combination with other cancer therapy agents including a Phase 2 clinical trial in head and neck cancer COLLABORATION WITH
© 2011 Idera Pharmaceuticalswww.iderapharma.com 8 IMO-2125: A Novel Immune Modulator for Treatment of Hepatitis C Virus Infection IMO-2125 induces TLR9-mediated immune responses including: Endogenous antiviral cytokines IFN-α, IP-10, 2’,5’-OAS, etc. Cellular activation: NK cells, monocytes, neutrophils Enhances Th1-type immune response IMO-2125 provides rationale for novel immune modulator as an alternative to recombinant interferon Th1-type immune responses Type I Interferons Cellular Activation B cellspDCs IMO-2125
© 2011 Idera Pharmaceuticalswww.iderapharma.com 9 IMO-2125: Phase 1 Clinical Trials in Null- Responder and Treatment-Naïve HCV Patients Two Phase 1 trials completed in 118 patients, four-week treatment periods Null-responder patients, IMO-2125 monotherapy 58 patients, 6 dose regimens Treatment-naïve patients, IMO-2125 plus ribavirin 60 patients, 4 dose regimens Comparative arm: Pegasys ® plus ribavirin Study endpoints Safety and tolerability Antiviral activity
© 2011 Idera Pharmaceuticalswww.iderapharma.com 10 IMO-2125: Safety Profile IMO-2125 was well-tolerated in approximately 96 patients No discontinuations, no treatment-related SAEs Most common AEs in patients receiving IMO-2125 were Mild-moderate injection site reactions (e.g., erythema, induration, tenderness) Mild-moderate flu-like symptoms (e.g., fever, chills, myalgias) Treatment-naïve patients receiving IMO-2125, compared to Pegasys ®, experienced: Shorter duration of flu-like symptoms Limited neutropenia and thrombocytopenia
© 2011 Idera Pharmaceuticalswww.iderapharma.com 11 IMO-2125: Antiviral Activity IMO-2125 induced a broad array of antiviral cytokines and chemokines, including interferon-alpha in both patient populations At all dose levels IMO-2125 induced declines in viral levels at 48 hours after the first dose in treatment-naïve patients IMO-2125 at all dose levels produced substantial viral load reductions after four weeks of treatment in both patient populations IMO-2125 treatment led to AST and ALT levels within normal limits by the end of the fourth week of treatment in treatment-naïve patients
© 2011 Idera Pharmaceuticalswww.iderapharma.com 12 IMO-2125: Planned Phase 2 Clinical Trial Patient Population and Treatment Treatment-naïve HCV-infected patients 12-week treatment period Treatment with IMO-2125 + ribavirin Control arm treated with Pegasys®+ribavirin Study endpoints: Detailed monitoring of safety and tolerability Antiviral activity Path forward to be determined after evaluation of data from nonclinical toxicology studies, which we expect will be available in 2H 2011 Planned Phase 2 trial designed to guide clinical development of IMO-2125 for use in combination with Direct-Acting Antiviral agents
© 2011 Idera Pharmaceuticalswww.iderapharma.com 13 IMO-3100: Novel Approach for Treating Autoimmune Diseases TLR7 and TLR9 are implicated in autoimmune and inflammatory diseases IMO-3100 inhibited immune responses mediated through TLR7 or TLR9 IMO-3100 activity confirmed in several preclinical models of autoimmune diseases including: lupus, psoriasis, rheumatoid arthritis and hyperlipidemia IMO-3100 inhibits induction of multiple cytokines and provides a novel approach for the treatment of autoimmune diseases IFN-α, IP-10, IL-12, IL-6, TNF-α, IL-1β, Anti-RNP, Anti-ds DNA B cellspDCs Immune complexes act as Endogenous Ligands XX IMO-3100 IFN-α, IP-10, IL-12, IL-6, TNF-α, IL-1β, Anti-RNP, Anti-ds DNA XX
© 2011 Idera Pharmaceuticalswww.iderapharma.com 14 IMO-3100: Safety and Mechanism of Action in Clinical Studies Two Phase 1 clinical trials completed in 60 healthy subjects Single-dose study 36 healthy subjects, 5 dose levels, placebo controlled Multiple-dose study for four weeks 24 healthy subjects, two dose cohorts, placebo controlled Study endpoints: Safety IMO-3100 well tolerated at all dose levels Mechanism of action Engagement of TLR7 & TLR9 confirmed in MO-3100-treated subjects through suppression of TNF-α, IL1β, IL-6, IFN-α and other cytokines
© 2011 Idera Pharmaceuticalswww.iderapharma.com 15 IMO-3100: Planning for Phase 2 Trial Anticipated completion of ongoing nonclinical safety studies 1H 2011 Submission of Phase 2 protocol expected 3Q 2011 Initiation of Phase 2 anticipated by year-end 2011 Study design anticipated to establish safety and activity of IMO-3100 over 12 weeks of treatment in a selected autoimmune disease indication IMO-3100 inhibits induction of multiple cytokines including TNF-α, IL-6, IL-1β, IP-10 and INF-α and provides a novel approach for the treatment of autoimmune diseases
© 2011 Idera Pharmaceuticalswww.iderapharma.com 16 Pipeline of Clinical and Preclinical Candidates Clinical Candidate: IMO-2134 TLR9 agonist for the treatment of respiratory diseases Phase 1 trial conducted in healthy subjects by Novartis Idera regained rights to this program from Novartis in 2010 Lead Candidate: IMO-4200 Dual TLR7 and 8 agonist for the treatment of hematological malignancies In preclinical lymphoma models, antitumor activity and potentiation of activity of Rituxan ® and Velcade ® Novel Discoveries: TLR3 agonist compounds Use as vaccine adjuvants being studied in infectious diseases and other indications
© 2011 Idera Pharmaceuticalswww.iderapharma.com 17 TLR Agonists: For Use as Vaccine Adjuvants Entered into collaboration with Merck & Co. in December 2006 for use of agonist of TLR7, 8 and 9 as vaccine adjuvants in the field of cancer, infectious diseases, and Alzheimer’s disease. Business terms $30M upfront payment Up to $425M potential milestone payments depending on vaccines and agonists employed Commercialization royalties: mid to upper single digit R&D costs covered by Merck Ongoing research Multiple scientific presentations by Merck on immunogenicity and adjuvant activity of TLR agonist in preclinical models
© 2011 Idera Pharmaceuticalswww.iderapharma.com 18 Novel Gene-silencing Oligonucleotide Technology Gene-silencing oligonucleotides (GSOs) are novel single-stranded DNA and RNA structures In vitro and in vivo data demonstrate that GSOs: Inhibit gene expression with 19-mer and 21-mer having most potent activity Engage a similar cellular mechanism as siRNAs Achieve systemic delivery without need for enhancement technology Provides new platform for target validation and discovery of novel drug candidates Next steps: conduct studies of GSOs targeted to mRNA and miRNA GSOs may overcome significant obstacles of antisense and siRNA technologies including stability, delivery and specificity
© 2011 Idera Pharmaceuticalswww.iderapharma.com 19 Financial Highlights 1Q 2011 2010 FY Net Loss$(6,845)$(17,963) Cash, Cash Equivalents & Investments $28,346$34,643 Net Cash Used in Operating Activities $6,300$19,556 Total Debt$ 0 Total Common Shares Outstanding 27,615,93327,595,920 Dollars in 000’s
© 2011 Idera Pharmaceuticalswww.iderapharma.com 20 2011 Anticipated Milestones Advancement of multiple clinical programs Completion of Phase 2 of IMO-2055 in oncology Determine path forward for IMO-2125 in HCV Initiation of Phase 2 clinical trial of IMO-3100 in an autoimmune indication Advancing the pipeline of candidates Outline development strategy of IMO-2134 in respiratory diseases and IMO-4200 in hematological malignancies Vaccine adjuvant application Advancement of ongoing preclinical studies Building alliances Assets include IMO-2125, IMO-3100, IMO-4200, and agonists of TLR3, TLR7, TLR8 and TLR9, and gene-silencing oligonucleotide technology COLLABORATION WITH
© 2011 Idera Pharmaceuticalswww.iderapharma.com 21 © 2011 Idera Pharmaceuticalswww.iderapharma.com 21 Clinical Pipeline Discovery Platform + Nasdaq: IDRA Translational Research
Michael V. Novinski President and Chief Executive Officer July 29, 2008 Eligen ® B12 – Human Clinical Results.
1 Michael V. Novinski President and Chief Executive Officer November 6, 2008 Third Quarter 2008 Earnings Conference Call.
1 Heather Davis September 27, 2011 Ottawa, Canada Biotech to Big Pharma Personal Experience.
Vijay B. Samant President and Chief Executive Officer September 2005.
1 3 RD Annual TBI Monique Létourneau Executive Vice-President & CFO September 21, 2007.
1 Marine Technology Summit November 16, Discovering and Developing New Medicines from Marine Microbes Nereus Pharmaceuticals Ken Lloyd, Ph.D. Chief.
John R. LaMontagne Memorial Symposium on Pandemic Influenza Research April 4-5, 2005 Institute of Medicine Working Group Four: Antivirals and Non-Specific.
Alemtuzumab BLA committee CD52 Expression Leukocytes B- lymphocytes T- lymphocytes Monocytes Macrophages Thymocytes Granulocytes (<5%)
The HCV vaccine: cooperation in the shadow of the pyramids Antonella Folgori.
Theme Colours HSV Oncolytic Immunotherapy BioTrinity 2016 Lynne Braidwood.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH Working with FDA: Biological Products and Clinical Development Critical Path.
Career Opportunities for PharmDs in the Pharmaceutical Industry: Research & Development.
Clinical Trial Design Considerations for Therapeutic Cancer Vaccines Richard Simon, D.Sc. Chief, Biometric Research Branch, NCI
Hepatitis C: Perspective on Drug Development Issues Debra Birnkrant, M.D. Director, Division of Antiviral Products FDA Antiviral Drugs Advisory Committee.
Small Molecules for Better Sight March 2013 Company Presentation March 2013 Company Presentation.
1 Global Health Research How the private sector contribute Bergen, 22. September 2004 Birger Sørensen, Adm.dir. Bionor Immuno AS.
2010 ASENT Conference March Highlights A novel mechanism of action and a new class of therapy in a large marketplace where existing mechanisms leave.
Investigational Drugs in the hospital. + What is Investigational Drug? Investigational or experimental drugs are new drugs that have not yet been approved.
The New Drug Development Process (www.fda.gov/cder/handbook/develop.htm)
Biomedical research methods. What are biomedical research methods? An integrated approach using chemical, mathematical and computer simulations, in vitro.
Hepatitis web study H EPATITIS W EB S TUDY H EPATITIS C O NLINE Ribavirin (Copegus, Rebetol, Ribasphere) Prepared by: David Spach, MD and H. Nina Kim,
Treatment Evaluation of HTLV infection treatment of asymptomatic HTLV carriers is not indicated.
New Technologies: the Role of the Private Sector Biotech’s Perspectives on Vaccine Development Alliances Peter Young CEO, AlphaVax, Inc.
Products, Pipeline and Profitability The Changing Face of ISTA.
1 Value Assessment of Development-Stage Assets Pharmaceutical Products, Medical Devices, and Related Intellectual Property Frank S. Castellana, M.D., Eng.Sc.D.
BUY Recommendation: Gilead Sciences (GILD). Company Overview Gilead Sciences, Inc. is a research-based biopharmaceutical company found in 1987 that discovers,
Frontier Pharma Innovative Licensing Opportunities in Non-Hodgkin Lymphoma 2015 Published on : August No. Pages : 115.
1 HIV Curative Strategies: Key Research Priorities Deeks S, et al., (2013) Nat Rev Immunol. 12(8):
Overview of the Keys to Successful Commercialization Gerald J. Siuta, Ph.D. President Siuta Consulting, Inc. Tucson, Arizona October 18, 2001.
1 Global Health Research How the private sector contribute Bergen, 22. September 2004 Birger Sørensen, President CEO Bionor Immuno AS.
Precise epidermal delivery v © Pantec Biosolutions AG, 2015 All rights reserved Confidentialslide 2 BEST-IN-CLASS LASER-ASSISTED EPIDERMAL DRUG.
2014 Annual Meeting of Stockholders Dan Moore, President & Chief Executive Officer September 18, 2014.
Exploratory IND Studies Michael Briggs, Operations Director Human Research Protections T HE U NIVERSITY OF N EW M EXICO.
Rituximab (RITUXAN) & Multiple Sclerosis Dr. Andrew Sylvester Attending Neurologist, IMSMP Assistant Clinical Scientist, MSRCNY.
Investor Presentation | October 2013 The future of drug discovery has arrived Reducing development time, cost & risk.
ChevronTexaco Corporation Peter Bijur Chairman & CEO Texaco Inc. Dave O’Reilly Chairman & CEO Chevron Corporation 1.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH Working with FDA: Biological Products and Clinical Development IND Case Studies.
TRANSLATIONAL RESEARCH New Therapies for MS Dennis Bourdette, M.D. and Arthur A. Vandenbark, Ph.D. TCR peptide therapy Recombinant TCR ligand (RTL) therapy.
Immuno-Oncology Axel Hoos, MD, PhD Senior Vice President, Oncology R&D February 24, 2016.
Anti-mRNA Strategies What is the antisense oligonucleotides? - Synthetic genetic material. - Interacts with natural genetic material (DNA or RNA) prevent.
Prof. Fatma Amer Medical Microbiology and Immunology, ZAGAZIG FACULTY OF Medicine, Egypt President of ISC/HWG President of ArAPUA In the Era of Direct.
The TB Alliance-Bayer Moxifloxacin Deal Gerald J. Siuta, Ph.D. Business Development Rockville, MD July 25, 2006.
1 SAFETY IMPLICATIONS FOR BIOTECH PRODUCTS Peter Feldschreiber & Leigh-Ann Mulcahy Four New Square.
Circadian: Developing tomorrow’s biological therapeutics for cancer.
ONCOLOGY Drug Development Fadi Sami Farhat, MD ONCOLOGY Drug Development Fadi Sami Farhat, MD Hematology Oncology
Drug Candidate safety testing Animal Studies - relevant species - transgenic KO/KI mice - conditional KOs - agonists/antagonists - antibodies - antisense.
Presentation by Dr. Andreas O. Tobler September 1, 2011 Tento projekt je spolufinancován Evropským sociálním fondem a státním rozpočtem České republiky.
Marine Drug Development and Delivery Prof. Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Department of Pharmaceutics KLE University College of Pharmacy BELGAUM ,
Food and Drug Administration Preclinical safety data for “first in human” (FIH) clinical trials in healthy volunteer subjects Oncology Drug Advisory Committee.
Stages of drug development Pharmacology lab MSc.Ikhlas Jarrar.
© 2017 SlidePlayer.com Inc. All rights reserved.