CAMBRIDGE, Mass. and EXTON, Pa., Nov. 09, 2016 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage
biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, today
announced that new data from the Phase 1/2 clinical trial for intratumoral IMO-2125, a TLR9 agonist, being evaluated for the
treatment of late-stage metastatic melanoma, will be presented at the 2016 Society for Immunotherapy of Cancer (SITC) Annual
Meeting in National Harbor, MD, November 9-13, 2016.
Oral Presentations
Date: Wednesday, November 9, 2016, Presentation Time: 11:15 AM E.T.
Session Title: Clinical New Agents in Development
Presentation Title: IMO-2125, An Investigational Intratumoral Toll-Like Receptor 9 Agonist, Modulates the Tumor
Microenvironment to Enhance Anti-Tumor Activity
Presenter: Mark J. Cornfeld, M.D. M.P.H., Vice President, Oncology Medical Lead, Idera Pharmaceuticals
Location: Gaylord National Hotel & Convention Center, Cherry Blossom Ballroom
Date: Friday, November 11, 2016, Presentation Time: 3:15 PM E.T.
Session Title: State of the Art Immunotherapies: Challenges and Opportunities
Presentation Title: Reactivating the anti-tumor immune response by targeting innate and adaptive immunity in a phase I/II study of
intratumoral IMO-2125 in combination with systemic ipilimumab in patients with anti-PD-1 refractory metastatic melanoma
Presenter: Presenter: Cara Haymaker, Ph.D., Instructor, The University of Texas MD Anderson Cancer Center
Location: Gaylord National Hotel & Convention Center, Maryland Ballroom
Poster Presentation
Date: Saturday, November 12, 2016: Presentation Time: 11:45 AM E.T. – 1:00 PM E.T.
Session Title: Immunotherapy
Poster Number: 216
Presentation Title: Reactivating the anti-tumor immune response by targeting innate and adaptive immunity in a phase I/II study of
intratumoral IMO-2125 in combination with systemic ipilimumab in patients with anti-PD-1 refractory metastatic melanoma
Presenter: Cara Haymaker, Ph.D., Instructor, The University of Texas MD Anderson Cancer Center
Location: Gaylord National Hotel & Convention Center, Prince George’s Exhibition Hall AB
A copy of the slides from Dr. Cornfeld’s presentation will be made available on Idera’s corporate website at http://www.iderapharma.com/our-approach/key-publications/ on Wednesday, November 9 at 11:15 AM
E.T. Copies of Dr. Haymaker’s presentation and related poster will be also be made available on Idera’s corporate website on
Friday, November 11 at 3:15 PM E.T., in accordance with the embargo policies set forth by SITC.
“As we noted in late September, we are extremely excited by the initial clinical outcomes we have generated with intratumoral
IMO-2125, in combination with ipilimumab,” stated Joanna Horobin, M.B., Ch.B., Idera’s Chief Medical Officer. “The
translational data from this trial is adding to our understanding of how IMO-2125 positively modulates the tumor microenvironment
and enabling previously cold tumors an opportunity for regression and ultimately successful outcomes for patients. The
translational research from this trial is critical to further this understanding as well as to help guide the direction of
IMO-2125’s development.”
These early results are from the phase 1 portion of study IMO-2125-204 (NCT02644967) in which cohorts of patients with
metastatic melanoma unresponsive to PD-1 inhibitor therapy are being administered escalating doses of IMO-2125 ranging from 4 mg/kg
through 32 mg/kg. IMO-2125 is injected intra-tumorally into a designated tumor lesion together with a standard dosing regimen of
ipilimumab. The trial has recently been amended to also study the combination of IMO-2125 and pembrolizumab given intravenously.
Following determination of the recommended phase 2 doses (RP2D) additional patients will be treated in an expansion phase 2 portion
of the study. The primary objective of the phase 1 portion of the trial is to characterize the safety and determine a RP2D of
IMO-2125 when administered intra-tumorally in combination with ipilimumab or pembrolizumab. The primary objective of the
phase 2 portion is to assess the clinical activity of IMO-2125 in each combination at the respective RP2Ds. Assessment will
be based on the immune-related response criteria (irRC) and additionally the traditional RECIST criteria. Serial biopsies are
being taken of selected injected and non-injected tumor lesions to assess immune changes and correlate with clinical response
assessments. The trial will enroll approximately 60 patients. The study is being conducted at The University of Texas
MD Anderson Cancer Center and is being led by Adi Diab, MD, Assistant Professor, Department of Melanoma Medical Oncology, Division
of Cancer Medicine, MD Anderson as part of a strategic research alliance announced by Idera and MD Anderson in 2015.
About Toll-like Receptors and Idera's Immuno-Oncology Research Program
Toll-like receptors (TLRs) play a central role in the innate immune system, the body's first line of defense against invading
pathogens, as well as damaged or dysfunctional cells including cancer cells. The innate immune system is also involved in
activating the adaptive immune system, which marshals highly specific immune responses to target pathogens or tissue. Cancer cells
may exploit regulatory checkpoint pathways to avoid being recognized by the immune system, thereby shielding the tumor from immune
attack. Checkpoint inhibitors such as agents targeting CTLA4 or programmed cell death protein 1 (PD1) are designed to enable the
immune system to recognize tumor cells. In this setting, intra-tumoral TLR9 agonist administration may increase the
tumor-infiltrating lymphocytes (TILs), and thereby potentiate anti-cancer activity of checkpoint inhibitors in the injected tumor
as well as systemically.
Idera’s TLR9 agonists, IMO-2125 and IMO-2055, have been created using the company's proprietary chemistry-based discovery
platform. IMO-2125 has been shown in various scientific presentations and publications to activate dendritic cells and induce
interferon. Idera selected IMO-2125 to advance into clinical development in combination with checkpoint inhibitors based on this
immunological profile. In previously completed clinical trials, subcutaneous administration of IMO-2125 was generally well
tolerated in about 80 patients with hepatitis C. Idera has conducted further preclinical research evaluating the potential of
IMO-2125 to enhance the anti-tumor activity of other checkpoint inhibitors in cancer immunotherapy with data being presented at
several medical conferences during the past twelve months. The posters from these presentations can be found at http://www.iderapharma.com/our-approach/key-publications.
About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in a type of skin cell called melanocytes. As is the case in many forms of
cancer, melanoma becomes more difficult to treat once the disease has spread beyond the skin to other parts of the body such as by
through the lymphatic system (metastatic disease). Melanoma accounts for only one percent of skin cancer cases, but causes a
large majority of skin cancer deaths. The American Cancer Society estimates that in 2016, there will be 76,380 new cases of
melanoma in the U.S., and about 10,130 will die of this disease.
About Idera Pharmaceuticals
Idera Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel nucleic acid-based therapies for the treatment
of certain cancers and rare diseases. Idera’s proprietary technology involves designing synthetic oligonucleotide-based drug
candidates to modulate the activity of specific TLRs. In addition to its TLR programs, Idera has used its proprietary knowledge to
create a third generation antisense technology platform which inhibits the production of disease-associated proteins by targeting
RNA. To learn more about Idera, visit www.iderapharma.com.
Forward Looking
Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact,
included or incorporated in this press release, including statements regarding the Company's strategy, future operations,
collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, plans, and
objectives of management, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects,"
"intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," and "would" and similar expressions are
intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Idera
cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements
and you should not place undue reliance on the Company's forward-looking statements. There are a number of important factors that
could cause Idera's actual results to differ materially from those indicated or implied by its forward-looking statements. Factors
that may cause such a difference include: whether interim results from a clinical trial, such as preliminary results reported in
this release, will be predictive of the final results of the trial, whether results obtained in preclinical studies and clinical
trials such as the preclinical data described in this release will be indicative of the results that will be generated in future
clinical trials, including in clinical trials in different disease indications; whether products based on Idera's technology will
advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and
Drug Administration or equivalent foreign regulatory agencies; whether, if the Company's products receive approval, they will be
successfully distributed and marketed; and such other important factors as are set forth under the caption "Risk Factors" in the
Company's Annual Report and on Form 10-Q for the period ended September 30, 2016. Although Idera may elect to do so at some point
in the future, the Company does not assume any obligation to update any forward-looking statements and it disclaims any intention
or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or
otherwise.
Investor and Media Contact Robert Doody Vice President, Investor Relations and Corporate Communications Office: 617-679-5515 Mobile: 484‐639‐7235 rdoody@iderapharma.com
