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© 2011 Idera 1 © 2011 Idera 1 Clinical Pipeline Discovery Platform + Nasdaq: IDRA.

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Presentation on theme: "© 2011 Idera 1 © 2011 Idera 1 Clinical Pipeline Discovery Platform + Nasdaq: IDRA."— Presentation transcript:

1 © 2011 Idera 1 © 2011 Idera 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

2 © 2011 Idera 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.

3 © 2011 Idera 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

4 © 2011 Idera 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

5 © 2011 Idera 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

6 © 2011 Idera 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 ®

7 © 2011 Idera 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

8 © 2011 Idera 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

9 © 2011 Idera 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

10 © 2011 Idera 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

11 © 2011 Idera 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

12 © 2011 Idera 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

13 © 2011 Idera 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

14 © 2011 Idera 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

15 © 2011 Idera 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

16 © 2011 Idera 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

17 © 2011 Idera 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

18 © 2011 Idera 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

19 © 2011 Idera 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

20 © 2011 Idera 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

21 © 2011 Idera 21 © 2011 Idera 21 Clinical Pipeline Discovery Platform + Nasdaq: IDRA Translational Research

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