On May 2, 2019 Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ: IDRA), a clinical-stage biopharmaceutical company focused on the development, and ultimately the commercialization, of therapeutic drug candidates for both oncology and rare disease indications, reported its financial and operational results for the first quarter ended March 31, 2019 (Press release, Idera Pharmaceuticals, MAY 2, 2019, View Source [SID1234535694]).
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"The first quarter of this year represented another period of solid execution from everyone on our team," stated Vincent Milano, Idera’s Chief Executive Officer. "During this quarter, we completed enrollment of ILLUMINATE-204, positioning ourselves to provide a full analysis from this trial in the fourth quarter of this year. We’ve also made significant progress with the enrollment of Idera’s first pivotal trial, ILLUMINATE-301, for which we expect to complete accrual during the fourth quarter. And, we recently presented the data from the ILLUMINATE-101 monotherapy trial at AACR (Free AACR Whitepaper), strengthening the body of translational and clinical evidence that tilsotolimod stimulates an immune response within the tumor microenvironment. We believe that this may be a key to enhancing the outcomes of existing immunotherapy regimens."
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, Bristol Myers Squibb, which assisted us in taking on this endeavor. Overall, this has been a highly productive quarter for our team and the momentum continues to swell as we advance towards these critical catalysts for our company."
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).
· On March 11, 2019 entered 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 Administration that 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 2018 which 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) (Free AACR Whitepaper) 2019 Annual Meeting on April 2, 2019 which demonstrated:
Safety Data
· 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).
Efficacy Data
· 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.
Translational Data
· 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.
Financial Results
First Quarter Results
Net loss applicable to common stockholders for the three months ended March 31, 2019 was $11.0 million, or $0.40 per basic and diluted share, compared to net loss applicable to common stockholders of $20.1 million, or $0.81 per basic and diluted share, for the same period in 2018. Revenue for each of the three months ended March 31, 2019 and 2018 was nominal. Research and development expenses for the three months ended March 31, 2019 totaled $8.1 million compared to $13.6 million for the same period in 2018. General and administrative expense for the three months ended March 31, 2019 totaled $3.1 million compared to $3.5 million for the same period in 2018. Merger-related costs, net for the three months ended March 31, 2018 totaled $3.4 million and related to our contemplated merger transaction. No such costs were incurred for the same period in 2019. Restructuring costs for the three months ended March 31, 2019 was nominal and related to our decision in July 2018 to wind-down our discovery operations. No such costs were incurred for the same period in 2018.
As of March 31, 2019, our cash, cash equivalents and investments totaled $59.9 million compared to $71.4 million as of December 31, 2018. We currently anticipate that, based on our current operating plan, our existing cash, cash equivalents and investments will fund our operations into the second quarter of 2020.