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Idera Completes Recruitment in Late-Stage Melanoma Study

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Idera Pharmaceuticals, Inc. IDRA announced that it has completed patient enrollment in the phase III ILLUMINATE-301 study, evaluating tilsotolimod in combination with Bristol-Myers’ BMY Yervoy (ipilimumab) for treating patients with anti-PD-1 refractory advanced melanoma.

Top-line overall response rate (ORR) and other preliminary data from this late-stage registrational ILLUMINATE-301 study are expected in the first quarter of 2021.

Per the company, tilsotolimod is an investigational an agonist of Toll-like receptor 9, which is being developed via intratumoral injection for addressing the given indication.

The randomized, ILLUMINATE-301 study is evaluating the effectiveness of intratumoral tilsotolimod in combination with Yervoy in patients with anti-PD-1 refractory advanced melanoma compared to Yervoy alone.

The primary endpoint of the study is ORR and the overall survival (OS) while the secondary endpoints include durable response rate, time to response, progression-free survival, safety and patient-reported outcomes.

Shares of Idera have plunged 41.9% in the past year compared with the industry’s decrease of 1.2%.

Tilsotolimod is also being evaluated in combination with several checkpoint inhibitors for treating multiple tumor types.

In January 2020, Idera announced an update on the clinical development program for tilsotolimod.

The phase II ILLUMINATE 206 study will evaluate the safety and effectiveness of tilsotolimod in combination with Yervoy and Bristol-Myers’ Opdivo (nivolumab) for the treatment of solid tumors.

Another phase I/II ILLUMINATE 204 study is designed to evaluate tilsotolimod in combination with Yervoy or Merck’s MRK Keytruda (pembrolizumab) in patients with anti-PD-1 refractory metastatic melanoma. Final results from the same are expected to be announced in the second quarter of 2020.

We remind investors that in 2017, the FDA granted Fast Track designation to the combo of tilsotolimod plus Yervoy for the treatment of anti-PD-1 refractory melanoma.

Zacks Rank & Key Pick

Idera currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Nabriva Therapeutics AG (NBRV - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Nabriva’s loss per share estimates have been narrowed 3.3% for 2020 over the past 60 days.

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