Wired News – Idera Pharma Gets Fast Track Designation for IMO-2125 in Combination with Ipilimumab for Treatment of PD-1 Refractory Metastatic Melanoma

Stock Monitor: Eleven Biotherapeutics Post Earnings Reporting

LONDON, UK / ACCESSWIRE / December 01, 2017 / Active-Investors issued a free report on Idera Pharma, Inc. (NASDAQ: IDRA), which is readily accessible upon registration at www.active-investors.com/registration-sg/?symbol=IDRA as the Company’s latest news hit the wire. On November 29, 2017, Idera declared that the US Food and Drug Administration (FDA) has granted Fast Track designation for its lead development candidate IMO-2125 for the treatment of anti-PD-1 refractory metastatic melanoma in combination with Ipilimumab therapy. Sign up now for our free research reports at:

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Metastatic Melanoma, a Rare Form of Skin Cancer

Melanoma is a rare form of skin cancer, but it accounts for over 75% of skin cancer deaths.

It starts in a type of skin cell called melanocytes. Just like other forms of cancer, melanoma becomes difficult to treat once it spreads beyond the skin to other parts of the body such as the lymphatic system (metastatic disease).

More often than not, melanoma occurs in younger individuals. Therefore, the number of years of life lost to melanoma is extremely high compared to other forms of cancer.

As per The American Cancer Society, approximately 76,000 new invasive melanoma cases and 10,000 deaths from the disease were reported in the US in 2016. Moreover, the World Health Organization estimates that around 132,000 new cases of melanoma are diagnosed around the world every year.

About IMO-2125

IMO-2125 is a toll-like receptor (TLR) 9 agonist, which signals the immune system to create and activate cancer-fighting cells (T-cells) to target solid tumors in refractory melanoma patients.

At present, approved immuno-oncology treatments for patients with metastatic melanoma, in particular, the checkpoint inhibitors, work for small group of patients. This is because the immune response for many patients is either missing or weak, and thus they do not benefit from the checkpoint therapy making them “refractory”.

The combination of ipilimumab and IMO-2125 helps to activate an immune response in those patients who have exhausted all other options.

The intratumoral injections with IMO-2125 are specifically designed to allow the T-cells to recognize and attack those cancers that were unrecognized by the immune system exposed to checkpoint inhibitors alone. However, these injections limit toxicity or impact on healthy cells in the body.

IMO-2125 received orphan drug designation from the FDA in 2017 for the treatment of melanoma Stages IIb to IV.

Implications of the Fast-track Status

FDA’s Fast Track Designation helps facilitate the development and expedite review of drugs to treat serious or life-threatening conditions.

Drugs that are meant to treat a serious or life-threatening condition, and have nonclinical or clinical data to validate their potential to address an unmet medical need qualify for the Fast Track designation.

If the request for Fast Track designation is made later in the development phase, the available clinical data must substantiate the drug’s potential for addressing an unmet medical need.

The FDA team provides multiple opportunities for interactions with the review team for a fast track product.

Moreover, a fast track product could also be eligible for priority review if it is supported by clinical data at the time of BLA, NDA, or efficacy supplement submission.

Forward Looking Remarks from Idera CMO

Joanna Horobin, M.B., Ch.B., and Chief Medical Officer at Idera, stated that this Fast Track designation is another positive step in the development of IMO-2125. He also believes that it highlights the serious unmet medical need that exists for patients who do not benefit from the existing anti-PD-1 therapy.

He added that his team is pleased with the response that they have received for IMO-2125 in combination with Ipilimumab. And according to him, they intend to continue enrolling more patients for the Phase-2 expansion of their ongoing trial and initiate the Phase-3 trial by the beginning of 2018.

Stock Performance Snapshot

November 30, 2017 – At Thursday’s closing bell, Idera Pharma’s stock rose 1.38%, ending the trading session at $2.21.

Volume traded for the day: 1.51 million shares.

Stock performance in the last month – up 41.67%; previous three-month period – up 11.62%; past twelve-month period – up 30.77%; and year-to-date – up 47.33%

After yesterday’s close, Idera Pharma’s market cap was at $421.01 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.8% at the end of the session.

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