On November 9, 2016 Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, reported 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) (Free SITC Whitepaper) Annual Meeting in National Harbor, MD, November 9-13, 2016 (Press release, Idera Pharmaceuticals, NOV 9, 2016, View Source;p=RssLanding&cat=news&id=2220898 [SID1234516450]).

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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 View Source 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 (Free SITC Whitepaper).

"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 View Source

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.