“Our team has demonstrated remarkable focus on execution during the first half of this year. We have made significant progress developing tilsotolimod and advancing it forward for patients facing the challenges of late-stage, anti-PD-1 refractory metastatic melanoma,” stated
Milano continued, “Additionally, we are providing data from the ILLUMINATE-204 trial, which we believe is informative as to the probability of success in the registrational trial. We also are advancing toward initiation of our first combination therapy trial in areas beyond melanoma, ILLUMINATE-206, which we expect will provide additional opportunities and milestones for data updates next year.”
ILLUMINATE (tilsotolimod) Clinical Development
ILLUMINATE 301 – Randomized phase 3 trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory metastatic melanoma:
- Overall Response Rate (ORR) and Overall Survival (OS) as family of primary endpoints;
- Trial initiated in the first quarter of 2018;
- Sites active in 11 countries: Approximately 100 sites participating.
Based on feedback from the ILLUMINATE-301 steering committee and global melanoma and immunology experts, we have elected to make the following modifications to the ILLUMINATE 301 trial design:
- Median OS improvement over ipilimumab alone of greater than or equal to 4.6 months from prior delta of improvement of 6.6 months;
- ORR improvement of 10 percentage points over ipilimumab alone from prior delta of improvement of 20 percentage points;
Targeteffect size/hazard ratio adjusted to 0.71 from 0.63; resulting in a planned enrollment of approximately 450 patients from 308, of which 294 are currently enrolled; and
- Targeting completion of enrollment during the first half of 2020.
We along with our collaboration partner, BMS, have amended the prior Clinical Trial Collaboration and Supply Agreement to accommodate the increase in supply of ipilimumab for the ILLUMINATE-301 trial.
Additionally, we have solicited feedback from the
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 at tilsotolimod 8 mg with ipilimumab in
- Data as of
August 5, 2019on endpoints:
- 27% ORR (n=13) of the 49 patients evaluable for efficacy; 74% (36) achieving disease control (best response of CR, PR or Stable Disease (SD));
- Durable responses (>6 mos.) observed in 8 of 13 responders;
- Median OS has not yet been reached (min/max: 1.6 mos. – 35 mos.);
- The safety profile observed in this analysis was consistent with previously reported results, with no emergence of new safety signals;
- 43% (n=21) of patients enrolled into trial presented at baseline with
Eastern Cooperative Oncology Group(ECOG) performance status 2; and
- Final results from the ILLUMINATE 204 trial are expected to be submitted for an abstract at a medical conference during the first half of 2020.
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, 2019, we entered into a second clinical trial collaboration with BMS in which BMS has agreed to manufacture and supply YERVOY (ipilimumab) and OPDIVO (nivolumab) for no charge for use in ILLUMINATE-206;
- Trial expected to initiate in the third quarter of 2019 beginning with the MSS-CRC cohort.
ILLUMINATE 101 – Phase 1b trial of tilsotolimod monotherapy in patients with refractory solid tumors:
- Completed enrollment in all dose cohorts of the trial;
- Initial data presented at
American Academy for Cancer Research(AACR) 2019 conference;
- Of 29 evaluable patients, 13 (45%) had a RECIST v1.1 disease assessment of stable disease (SD), with a disease control rate of 45%;
- One patient with uterine leiomyosarcoma has been on tilsotolimod treatment for more than a year with durable stable disease and is continuing under a treatment investigational new drug;
- One patient in the melanoma cohort achieved an unconfirmed RECIST v.1.1 partial response (PR) with 35% tumor shrinkage in the target lesion; and
- Abstract submission accepted for poster presentation at the
European Society for Medical Oncology2019 Conference being held in Barcelona, Spainin September 2019.
Elizabeth A. Tarka, MD, FACCwas appointed as Chief Medical Officer effective July 22, 2019; and John J. Kirbywas appointed as Chief Financial Officer effective July 22, 2019.
Upcoming Investor Presentation:
- The company will be presenting at the 2019
Wedbush PacGrow Healthcare Conferenceon Tuesday, August 13, 2019at 1:20 PM ET. The conference is being held at the Parker New York Hotel. The webcast can be accessed live or in archived form in the “Investors” section of the company’s website at www.iderapharma.com.
Second Quarter Results
Net loss applicable to common stockholders for the three months ended
Investor Event and Webcast
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||Six Months Ended|
|June 30,||June 30,|
|Research and development||10,024||10,880||18,126||24,436|
|General and administrative||2,895||4,000||6,038||7,481|
|Merger-related costs, net||-||1,583||-||5,081|
|Total operating expenses||12,964||16,463||24,340||36,998|
|Loss from operations||(11,516||)||(16,300||)||(22,892||)||(36,580||)|
|Other income (expense), net||340||269||742||454|
|Net loss per common share applicable to common stockholders — basic and diluted||$||(0.39||)||$||(0.59||)||$||(0.79||)||$||(1.39||)|
|Weighted-average number of common shares used in computing net loss per share applicable to common stockholders — basic and diluted||28,461||27,133||28,070||26,012|
Condensed Balance Sheet Data
|June 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||52,373||$||71,431|
|Total stockholders' equity||47,735||63,994|
|Total liabilities and stockholders' equity||$||54,332||$||73,023|
Idera Pharmaceuticals Contact:
SVP, Investor Relations
Phone (484) 348-1677
Source: Idera Pharmaceuticals, Inc.