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Will ILLUMINATE-301 Light Up Idera Pharma?

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Shares of Idera Pharmaceuticals Inc. (IDRA) are up nearly 24% year-to-date as the company looks forward to sharing data from its Tilsotolimod trials in the coming months.

Tilsotolimod, the company's lead drug candidate, is a synthetic toll-like receptor 9 (TLR9) agonist that modulates the tumor immune microenvironment.

A phase III study evaluating Tilsotolimod in combination with Bristol Myers Squibb's Yervoy against Yervoy alone in patients with advanced melanoma following progression on or after anti-PD-1 therapy, dubbed ILLUMINATE-301 is underway.

The ILLUMINATE-301 trial, which began in May 2018, completed enrollment of 481 patients across 80 sites in 11 countries last March. The primary endpoints are overall response rate (RECIST v1.1) and overall survival. Secondary endpoints include durable response rate, time to response, progression-free survival, patient-reported outcomes, and safety.

The company expects to announce top-line overall response rate (ORR) and other preliminary data from ILLUMINATE-301 late in this quarter.

If all goes well and Tilsotolimod reaches the pharmacy shelves, the company expects the drug candidate to bring in peak sales of roughly $600 million in the U.S. and about $350 million in the EU.

The potential of Tilsotolimod is also being explored in immunotherapy-naive micro-satellite stable colorectal cancer (MSS-CRC), and a phase II trial in this indication, dubbed ILLUMINATE-206, is underway.

The ILLUMINATE-206 trial is evaluating the combination of Tilsotolimod with Bristol Myers Squibb's Opdivo and Yervoy in micro-satellite stable colorectal cancer.

According to preliminary data from the ILLUMINATE-206 trial, reported last June, 6 of the progressing patients had stability or reduction in size of injected lesions, and 6 had stability or reduction in overall size of non-injected lesions. Updated data from this trial is expected in the third quarter of this year.

Idera has an immuno-oncology clinical research collaboration with AbbVie that was signed in September 2019.

Under the collaboration, a phase I trial evaluating ABBV-368 plus Tilsotolimod and other therapy combinations in participants with recurrent/metastatic Head and Neck Squamous Cell Carcinoma was started last January, and is recruiting patients.

Cash position:

Idera, which ended September 30, 2020, with cash, cash equivalents, and short-term investments of $29.0 million, raised up to $20.7 million in gross proceeds in a private placement in December 2020.

IDRA has traded in a range of $0.81 to $6.14 in the last 1 year. The stock closed Monday's trading at $4.54, down 4.62%.

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