On November 6, 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 operational and financial results for the third quarter ended September 30, 2019 (Press release, Idera Pharmaceuticals, NOV 6, 2019, View Source [SID1234550471]).
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"The third quarter of this year marked another consecutive period of focused execution for our company as we continue advancing tilsotolimod for patients and their families," stated Vincent Milano, Idera’s Chief Executive Officer. "During this quarter, we implemented adjustments for ILLUMINATE-301 and continue to make meaningful progress with patient enrollment. Additionally, we also had strong execution within the broader tilsotolimod program, highlighted by the initiation of our first tumor expansion efforts in ILLUMINATE-206, the lengthening of our exclusivity period and the strategic clinical collaboration with AbbVie."
Milano continued, "Overall, our team is executing on a high level and we are well positioned to continue to accelerate our activity through the end of this year and, importantly, into 2020."
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:
· Approximately 90 sites active in 11 countries;
·Planned enrollment target of 454 patients;
· As of October 23, 2019, 342 patients enrolled representing 75% enrollment;
·Targeting completion of enrollment during first half of 2020; and
·Clinical trial collaboration and supply agreement in place with BMS for supply of ipilimumab for the trial.
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 (49 evaluable) at tilsotolimod 8 mg with ipilimumab in February 2019;
· Of the four unconfirmed responders of the 13 responders reported on Aug. 8, 2019:
· Two were confirmed per RECIST v1.1 criteria, one remains unconfirmed, and one experienced disease progression, leading to a total of 11 of 12 confirmed responses, as of Oct. 23, 2019;
·3 confirmed complete responses (CR);
· 71% (35) achieving disease control (best response of CR, PR or Stable Disease (SD)); and
·Durable responses (greater than six months) were observed in five of 10 confirmed responses per RECIST v1.1.
·Safety profile observed consistent with previously reported results; 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 anti-PD-1 Refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Relapsed/Refractory Immunotherapy-Naïve Microsatellite Stable Colorectal Cancer (MSS-CRC).
· Trial initiated on September 30, 2019, leading 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;
·Data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Conference in Barcelona Spain;
·Of 45 evaluable patients, 15 (33.3%) had best response of stable disease (SD);
·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 partial response (uPR). This patient discontinued from the study prior to the confirmation of response.
AbbVie Collaboration — On September 4, 2019, we announced we had entered into an immuno-oncology clinical research collaboration with AbbVie, a global, research-based biopharmaceutical company. The purpose of the collaboration is to conduct a clinical study evaluating whether combinations of an OX40 agonist (ABBV-368), a TLR-9 agonist (tilsotolimod), chemotherapy (nab-paclitaxel) and/or an anti-programmed cell death 1 (PD-1) antagonist (ABBV-181) stimulate the immune system resulting in anti-tumor responses.
Intellectual Property — On November 5, 2019, the U.S. Patent and Trademark Office issued U.S. Patent No. 10,10,463,686 entitled "Immune Modulation With TLR9 Agonists For Cancer Treatment," which includes the Company’s investigational therapy tilsotolimod (IMO-2125). The patent includes 24 claims directed to methods of treating melanoma with intratumoral administration of tilsotolimod in combination with certain immune checkpoint inhibitor therapies including inhibitors of the CTLA-4 and PD-1/PD-L1 pathways. The patent is expected to expire in September 2037.
Financial Results
Third Quarter Results
Net loss applicable to common stockholders for the three months ended September 30, 2019 was $11.1 million, or $0.39 per basic and diluted share, compared to net loss applicable to common stockholders of $11.6 million, or $0.43 per basic and diluted share, for the same period in 2018. Research and development expenses for the three months ended September 30, 2019 totaled $8.4 million compared to $8.9 million for the same period in 2018. General and administrative expense for the three months ended September 30, 2019 totaled $3.0 million compared to $4.0 million for the same period in 2018. Merger-related costs, net for the three months ended September 30, 2018 amounted to a net credit of $3.8 million and was comprised of a $6.0 million fixed expense reimbursement received in connection with the termination of a merger agreement in July 2018, partially offset by $2.2 million of expenses incurred in connection with transactions contemplated by such merger agreement. No such costs were incurred for the same period in 2019. Restructuring costs for the three months ended September 30, 2019 were less than $0.1 million compared to $3.0 million for the same period in 2018 and related to our decision in July 2018 to wind-down our discovery operations.
As of September 30, 2019, our cash, cash equivalents and short-term investments totaled $41.6 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 on hand as of September 30, 2019, will fund our operations into the third quarter of 2020.