Idera Pharmaceuticals Presents Update from Ongoing Phase 1 Dose Escalation Clinical Trial of Intratumoral IMO-2125 in Combination with Ipilimumab in Metastatic Melanoma Patients Refractory to Anti-PD-1 Treatment at the 2017 ASCO-SITC Clinical Immuno-Oncol

ORLANDO, FL, USA I February 24, 2017 I Idera Pharmaceuticals, Inc. (IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, today is reporting additional data from the dose-escalation phase of its ongoing Phase 1/2 clinical trial of intratumoral IMO-2125, an agonist of TLR9 in combination with ipilimumab or pembrolizumab for treatment of patients with metastatic melanoma with disease that is refractory to PD-1 inhibitors.

In the poster presentation at the 2017 ASCO-SITC Clinical Immuno-Oncology Symposium, entitled, “Intratumoral (i.t.) IMO-2125, a TLR9 agonist is active in combination with ipilimumab (ipi) in PD-(L)1 refractory melanoma (RM),” Marc Uemura, M.D. from the University of Texas, MD Anderson Cancer Center, presented an update on the clinical and translational findings from the ongoing trial.

A copy of the poster presentation is currently available on Idera’s corporate website at http://www.iderapharma.com/our-approach/key-publications/.

“We are very pleased to have achieved successful completion of all our objectives in the Phase 1 portion of this trial which established safety across all doses tested, and demonstrated preliminary evidence of clinical activity, including durable responses of over one year in two of the evaluable patients so far,” stated Mark Cornfeld, M.D., Idera’s Medical Lead, Oncology.  “Additionally from a scientific standpoint, we’ve established proof of mechanism through our translational effort which has gone well beyond the norm compared to what is typically done in oncology drug development.”

Continued Cornfeld, “At this point we have very clear justification to further the development of IMO-2125 and we’ll soon be moving to the phase 2 portion of the trial, which will expand to multiple centers.  Additionally we are undertaking a parallel development pathway for IMO-2125 in combination with pembrolizumab and while that is not the focus of this presentation today, we are making good progress with safety and dose evaluation in that arm.”

The company is also announcing the acceptance of two abstracts at the upcoming American Association for Cancer Research (AACR) 2017 Annual Meeting being held April 1-5, in Washington DC. Idera has gained acceptance of two presentations related to IMO-2125.

On Wednesday, April 5, 2017, Dr. Cara Haymaker of MD Anderson Cancer Center will present an update on the translational data outcomes in a poster presentation entitled, “Translational evidence of reactivated innate and adaptive immunity with intratumoral IMO-2125 in combination with systemic checkpoint inhibitors from a Phase 1/2 study in patients with anti-PD-1 refractory metastatic melanoma.”

Additionally, on the same day, Daqing Wang, Ph.D., Principal Scientist, Idera Pharmaceuticals will present new IMO-2125 pre-clinical data in a poster entitled, “Local treatment with novel TLR9 agonist IMO-2125 demonstrates anti-tumor activity in preclinical models of pancreatic cancer.” 

About IMO-2125
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, intratumoral 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 agonist, IMO-2125 has 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.

SOURCE: Idera Pharmaceuticals

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