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Idera Pharmaceuticals Announces Acceptance of Several Abstracts related to the ILLUMINATE Tilsotolimod Clinical Development Program at the American Society of Clinical Oncology (ASCO) Meeting

- ILLUMINATE 204 Data selected as subject of a poster discussion session to be held on Monday, June 4, 2018 at 4:45 PM CT

- Idera to host Investor/Analyst Event at ASCO on Monday, June 4, 2018 at 6:30 PM CT -

EXTON, Pa., April 26, 2018 (GLOBE NEWSWIRE) -- Idera Pharmaceuticals, Inc. (Idera) (NASDAQ:IDRA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel oligonucleotide therapeutics for oncology and rare diseases, today announced the acceptance of three abstracts related to the ILLUMINATE clinical development program at the upcoming ASCO meeting being held June 1-5, 2018 in Chicago. The abstracts include a clinical data update from the ILLUMINATE 204 trial in anti-PD-1 refractory melanoma provided by lead investigator Adi Diab, MD from the University of Texas MD Anderson Cancer Center; this abstract will also be featured in a poster discussion session at the meeting.  

The company plans to hold an investor/analyst event at the ASCO Annual Meeting on Monday, June 4, 2018, which will feature a presentation by ILLUMINATE 204 lead investigator Adi Diab, MD as well as Q&A with attendees.  As a convenience to those unable to attend in person, the event will be webcast. Full event details will be provided closer to the meeting.

Additionally, the Phase 3 ILLUMINATE 301 trial in anti-PD-1 refractory melanoma has opened to enrollment during the first quarter of 2018.

Accepted Abstracts for ASCO 2018:

             
Title (1):         A phase 2 study to evaluate the safety and efficacy of Intratumoral (IT)
injection of the TLR9 agonist IMO-2125 (IMO) in combination with
ipilimumab (ipi) in PD-1 inhibitor refractory melanoma.
 
             
Abstract Number:         9515  
Poster Display Session:         Melanoma/Skin Cancers  
Date:         June 4, 2018, 1:15 – 4:45 PM CT  
Location:         Hall A  
Presenter:         Adi Diab, MD, MD Anderson Cancer Center  
             
Poster Discussion Session:         Melanoma Skin Cancers  
Date:         June 4, 2018 4:45 – 6:00 PM CT  
Location:         E451  
             


             
Title (2):         Preliminary safety of deep/visceral (D/V) image guided (IG) intratumoral
injection (ITI) of IMO-2125.
 
Abstract Number
For Publication:
        e15150  
Author:         Hani Babiker, MD, University of Arizona Cancer Center  
             
Title (3):         Right tumor, right time: Systematic methodology for fiducial marker
placement to achieve reliable and reproducible image guided (IG)
delivery of intratumoral immunotherapy into deep/visceral (D/V) lesions
and target-lesion imaging follow-up.
 
Abstract Number
For Publication:
        e24137  
Author:         Gregory John Woodhead, MD, PhD, University of Arizona Cancer Center  
             

About Tilsotolimod (IMO-2125)
Tilsotolimod is a TLR 9 agonist that received Fast Track Designation from the US Food and Drug Administration (FDA) in 2017 for the treatment of PD-1 refractory melanoma, in combination with ipilimumab as well as orphan drug designation from the FDA for the treatment of melanoma Stages IIb to IV. It signals the immune system to create and activate cancer-fighting cells (T-cells) to target solid tumors.  Currently approved immuno-oncology treatments, specifically check-point inhibitors, work for some but not all, as many patients’ immune response is missing or weak and thus they do not benefit from the checkpoint therapy. Intratumoral injections with tilsotolimod are designed to selectively enable the T-cells to recognize and attack cancers that remained elusive and unrecognized by the immune system exposed to checkpoint inhibitors alone, while limiting toxicity or impact on healthy cells in the body.

About ILLUMINATE-204
The Illuminate 204 study (2125-204) is for patients who have metastatic melanoma for whom treatment with an anti-PD-1 drug like Keytruda® (pembrolizumab) or Opdivo® (nivolumab) has failed. Melanoma is the most dangerous type of skin cancer. When it is metastatic, it means that the melanoma has spread to different parts of the body.  Illuminate 204 is a multi-center, two-arm Phase 1/2 study that tests the safety and effectiveness of tilsotolimod in combination with either ipilimumab (Yervoy®) or pembrolizumab (Keytruda®) for the treatment of patients with PD-1 refractory metastatic melanoma.

For additional details about Illuminate 204, please go to clinicaltrials.gov and search for study identifier NCT02644967.

About ILLUMINATE-301
The Illuminate 301 study (2125-MEL-301) is for patients who have metastatic melanoma for whom treatment with an anti-PD-1 drug like Keytruda® (pembrolizumab) or Opdivo® (nivolumab) has failed.  Illuminate 301 is a multi-center, randomized Phase 3 study that compares the effectiveness and safety between two treatment groups: IMO-2125 combined with ipilimumab (Yervoy®) versus ipilimumab given alone.

For additional details about Illuminate 301, please go to clinicaltrials.gov and search for study identifier NCT03445533.

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 the lymphatic system (metastatic disease). Because melanoma occurs in younger individuals, the years of life lost to melanoma are also disproportionately high when compared with other cancers.  Although melanoma is a rare form of skin cancer, it comprises over 75% of skin cancer deaths.  The American Cancer Society estimates that there were approximately 76,000 new invasive melanoma cases and 10,000 deaths from the disease in the USA in 2016.  Additionally, according to the World Health Organization, about 132,000 new cases of melanoma are diagnosed around the world every year.

             
About Idera
Harnessing the approach of the earliest researchers in immunotherapy and the company’s vast experience in developing proprietary immunology platforms, Idera’s lead development program is focused on priming the immune system to play a more powerful role in fighting cancer, ultimately increasing the number of people who can benefit from immunotherapy. Idera continues to invest in research and development, and is committed to working with investigators and partners who share the common goal of addressing the unmet needs of patients suffering from rare, life-threatening diseases. 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, clinical trials, 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 the company’s cash resources will be sufficient to fund the company’s continuing operations and the further development of the company’s programs for the period anticipated; whether interim results from a clinical trial, such as the 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 results 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 when anticipated or at all or warrant submission for regulatory approval; whether such products will receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the company's products receive approval, they will be successfully distributed and marketed; whether the company's collaborations will be successful; and such other important factors as are set forth under the caption "Risk factors" in the company’s Annual Report filed on Form 10-K for the period ended December 31, 2017. 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.

Idera Pharmaceuticals Contact:
               
Robert A. Doody, Jr.
VP, Investor Relations & Communications
Phone (484) 639-7235
rdoody@iderapharma.com

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Source: Idera Pharmaceuticals, Inc.