EXTON, PA — Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), or Idera or the Company, this week is providing an update on its tilsotolimod clinical development program and providing a corporate outlook for 2020.
“We made tremendous progress last year with the tilsotolimod clinical development program, and we are positioned well going into this pivotal year,” stated Vincent Milano, Idera’s Chief Executive Officer. “Our ILLUMINATE-301 registrational trial of tilsotolimod in anti-PD-1 refractory metastatic melanoma is enrolling at a rate that dramatically exceeded our expectations. We expect to complete enrollment this quarter, setting up the possibility of data before the end of this year. We believe the rapid enrollment in this randomized trial is a testament to the critical unmet need for this patient group as well as to the growing appreciation from global investigators for both intratumoral administration and the mechanism of action of tilsotolimod.”
Continued Milano, “We also will add to the overall body of clinical evidence for tilsotolimod with additional data readouts expected in the second quarter. Final analysis of ILLUMINATE-204 will include median overall survival (OS) for the first time, and ILLUMINATE-206 will provide safety and preliminary efficacy in microsatellite-stable colorectal cancer (MSS-CRC) as a triple combination of ipilimumab, nivolumab and tilsotolimod in this immunorefractory indication.”
“Lastly, we recently entered into a financing agreement that provides financial resources for these critical catalysts and beyond. Overall, we are looking forward to 2020 and delivering on the goals we set for patients and our investors when we initiated the development of tilsotolimod.”
ILLUMINATE (tilsotolimod) Clinical Development Program
ILLUMINATE 301 – Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory metastatic melanoma:
- Approximately 100 sites active in 11 countries;
- Planned enrollment target of 454 patients;
- As of January 13, 2020, 427 patients enrolled, representing 94% enrollment; and
- Targeting completion of enrollment during Q1 2020; and data in Q4 2020/Q1 2021.
ILLUMINATE 206 – Phase 2, open-label, multi-cohort, multi-center study to test the safety and effectiveness of tilsotolimod in combination with ipilimumab and nivolumab for the treatment of solid tumors:
- Trial initiated on September 30, 2019, leading with the MSS-CRC cohort;
- Initial safety run-in cohort of 10 patients with MSS-CRC fully enrolled; and
- Preliminary objective response rate (ORR) and safety data from this cohort expected in Q2 2020.
ILLUMINATE 204 – Phase 1/2 trial of tilsotolimod in combination with ipilimumab or pembrolizumab in patients with anti-PD-1 refractory metastatic melanoma:
- Completed enrollment with 52 patients (49 evaluable) at tilsotolimod 8 mg with ipilimumab in February 2019; and
- Final results from the ILLUMINATE 204 trial are expected to be released in Q2 2020;
- Data to be presented include ORR, median OS, duration of response (DOR) and safety.
Upcoming Corporate Presentation
Idera Chief Executive Officer Vincent Milano will provide a corporate overview at the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020 at 7:30 AM PT/ 10:30 AM ET. The conference is being held at the Westin St. Francis Hotel in San Francisco, CA. A copy of the Company’s J.P. Morgan corporate presentation will be posted on the Investors’ page of the Company’s corporate website on Wednesday January 15, 2020 prior to the opening of the U.S. markets.
Live audio webcast of Idera’s presentations will be accessible in the Investors section of Idera’s website at http://www.iderapharma.com. Archived versions will also be available on the Company’s website after the event for 90 days.
Source: Idera Pharmaceuticals, Inc., 505 Eagleview Blvd, Exton PA 19341
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