“The first quarter of this year represented another period of solid execution from everyone on our team,” stated
Milano continued, “Lastly, we’ve made great strides in preparing to initiate the expansion of activities for tilsotolimod through the ILLUMINATE-206 multi-cohort trial, which we anticipate will launch this quarter. We appreciate the financial commitment and teamwork from our collaboration partner,
ILLUMINATE (tilsotolimod) Clinical Development
ILLUMINATE 301 – Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with PD-1 refractory metastatic melanoma:
- Overall Response Rate (ORR) and Overall Survival (OS) as primary endpoints;
- Trial initiated in the first quarter of 2018;
- Sites planned in 12 countries: 85 sites activated;
- Planned enrollment of approximately 300 patients; and
- Completion of enrollment expected during the fourth quarter of 2019.
ILLUMINATE 206 – Phase 2, multi-center trial to test the safety and effectiveness of tilsotolimod in combination with ipilimumab and nivolumab in treating patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Microsatellite Stable Colorectal Cancer (MSS-CRC).
March 11, 2019entered into a second clinical trial collaboration with Bristol-Myers Squibb(BMS) in which BMS has agreed to manufacture and supply YERVOY (ipilimumab) and OPDIVO (nivolumab) at its cost and for no charge for use in ILLUMINATE-206;
- Received notice from the
U.S. Food and Drug Administrationthat we can proceed to implement the ILLUMINATE-206 clinical trial under a new Investigational New Drug (IND) application; and
- Both trial cohorts of SCCHN and MSS-CRC expected to initiate in the second quarter of 2019.
ILLUMINATE 204 – Phase 1/2 trial of tilsotolimod in combination with ipilimumab or pembrolizumab in patients with PD-1 refractory metastatic melanoma:
- Completed enrollment with 52 patients dosed in Phase 2 expansion at tilsotolimod 8 mg with ipilimumab;
- Completed target enrollment of at least 40 patients in the primary enrollment population constituting patients who are naïve to prior ipilimumab treatment in the metastatic setting;
- Presented an interim data update in
December 2018which showed:
- 32.4% ORR of the first 34 patients evaluable for efficacy including 9% (n=3) achieve Complete Response (CR); 24% (n=8) achieving Partial Response (PR); and 76.5% (n=26) achieving disease control (CR, PR or Stable Disease [SD]); and
- Final overall response rate (ORR) data from the ipilimumab combination arm of ILLUMINATE-204 expected in the fourth quarter of 2019.
ILLUMINATE 101 – Phase 1b trial of tilsotolimod monotherapy in patients with refractory solid tumors:
- Completed enrollment in all dose cohorts of the trial; and
- Poster presented at the
American Association for Cancer Research(AACR) 2019 Annual Meeting on April 2, 2019which demonstrated:
- No dose limiting toxicities or treatment-related adverse events were observed;
- No treatment-emergent adverse events (TEAEs) leading to treatment or study discontinuation or death occurred; and
- The most common grade 3/4 TEAEs were anemia, hyponatremia, pain, sepsis (n=3 each), fatigue and thrombocytopenia (n=2 each).
- Of 29 evaluable patients, 13 (45%) had a RECIST v1.1 disease assessment of stable disease (SD), with a disease control rate of 45%;
- Of the 13 patients with SD, 5 (38%) had maximum tumor shrinkage >10% below baseline;
- Duration of SD ranged from 1.3 to 9.7+ months from start of treatment, with 3 patients ongoing; and
- No correlations between dose and efficacy were observed.
- Fresh flow cytometry in 2 of 3 analyzed patients showed HLA-DR (MHC Class II) upregulation at 24 hours compared with pre-treatment; and
- Robust activation and upregulation of type I IFN pathway was observed across analyzed tumor types, demonstrated by increased IRF7, IFIT1, and IFIT2 gene expression, and early increases in type I IFN signaling.
First Quarter Results
Net loss applicable to common stockholders for the three months ended
Harnessing the approach of the earliest researchers in immunotherapy and the company’s vast experience in developing proprietary immunomodulatory platforms, Idera’s TLR agonist 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.
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, 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.
Condensed Statements of Operations
(In thousands, except per share data)
|Three Months Ended|
|Research and development||8,102||13,556|
|General and administrative||3,143||3,481|
|Merger-related costs, net||-||3,498|
|Total operating expenses||11,376||20,535|
|Loss from operations||(11,376||)||(20,280||)|
|Other income (expense), net||402||185|
|Net loss per common share applicable
to common stockholders — basic and diluted
|Weighted-average number of common shares used in computing net
loss per share applicable to common stockholders — basic and diluted
Condensed Balance Sheet Data
|March 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||59,864||$||71,431|
|Total stockholders' equity||55,672||63,994|
|Total liabilities and stockholders' equity||$||62,001||$||73,023|
Idera Pharmaceuticals Contact:
VP, Investor Relations
Phone (484) 348-1677
Source: Idera Pharmaceuticals, Inc.