“2018 has the opportunity to be a truly transformative year for
Milano continued, “Outside of the exciting progress we are making clinically with our programs, we continue to be extremely active in business development. We plan to explore partnering opportunities as well as identify assets that fit within our corporate strategy of building a company focused on delivering solutions for patients with rare unmet medical needs.”
Clinical Development Programs:
ILLUMINATE 204 – Phase 1/2 Trial of IMO-2125 in Combination with Ipilimumab or Pembrolizumab in patients with PD-1 refractory metastatic melanoma
- Enrolled 21 patients at 8mg (RP2D) dose with ipilimumab;
- 5 of the first 10 evaluable patients responders;
- 5 Trial sites currently enrolling patients with goal of expansion to 10 sites during first half of 2018; and
- In pembrolizumab combination arm of the trial, phase 1 dose escalation continues into the last dosing cohort (32mg).
- Next expected clinical data update expected around the
American Society of Clinical Oncology( ASCO) Annual Meeting in June 2018.
ILLUMINATE 101 – Phase 1b Trial of Intratumoral IMO-2125 Monotherapy in Patients with Refractory Solid Tumors
- Completed enrollment in first cohort (11 patients treated with 8mg dose of IMO-2125);
- Three subjects in cohort 1 (8 mg) continue IMO-2125 monotherapy on the 101 study. Initial investigator assessments indicate stable disease (SD) in 2 of these subjects (pancreatic, colorectal), and 1 irSD (pancreatic) in the third. While these are preliminary data, we are hopeful for these subjects and their ongoing care and upcoming disease assessments; and
- Advanced to enrollment of second cohort (9 patients treated with 16mg dose of IMO-2125).
ILLUMINATE 301 – Phase 3 Trial of IMO-2125 in Combination with Ipilimumab in patients with PD-1 refractory metastatic melanoma
- Trial planned for initiation during Q1 2018;
- Approximately 70 Sites selected for trial participation across 12 countries;
- Planned enrollment of roughly 300 patients with Overall Response Rate (ORR) and Overall Survival (OS) as trial endpoints; and
U.S. Food and Drug Administrationgranted Fast Track Designation for IMO-2125 in combination with ipilimumab for treatment of PD-1 refractory metastatic melanoma in fourth quarter of 2017.
Pioneer (IMO-8400) Development Activities
PIONEER – Phase 2 Trial of IMO-8400 in Adult Patients with Dermatomyositis
- Enrollment concluded during Q3 2017 (30 patients); and
- Full Phase 2 trial data expected in Q2 2018.
IDRA – 008 Development Activities
- Selected Apolipoprotein C-III (APOC-III) as first gene target for development for treatment of Familial Chylomicronemia Syndrome (FCS) and Familial Partial Lipodystrophy (FPL);
- Completion of Pre-clinical toxicology and IND-enabling studies in Q1 2018;
- Pre-clinical pharmacology study in Cyno-model comparing IDRA-008 to competitive development asset, Volanesorsen expected to readout during Q1 2018;
- Development decision for IDRA-008 expected during Q1 2018; and
Evaluation of rare-disease opportunities for application of Idera’s core oligonucleotide research capability and expertise to yield innovative oligonucleotide therapeutic concepts that address significant unmet medical needs on-going in Q1 2018.
January 4, 2018, shareholders voted to approve giving the Board of Directors discretion to implement a reverse stock split of not less than 1-for-4 and not more than 1-for-8; and
- Company anticipates current cash position capable of funding operations into the second quarter of 2019.
Upcoming Corporate Presentation
A copy of the company’s J.P. Morgan corporate presentation will be posted on the Investor’s page of the company’s corporate website prior to the start of the conference on
Live audio webcast of Idera’s presentations will be accessible in the Investors and Media 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.
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.
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 Pharmaceuticals Contact:
VP, Investor Relations
Phone (484) 639-7235
Source: Idera Pharmaceuticals, Inc.