Today, Idera Pharmaceuticals Inc (NASDAQ:IDRA) investors woke up to a nice pop in the value of their shares, after the drug maker presented positive phase 1 data for Intratumoral IMO-2125 (Idera’s intratumorally-delivered Toll-like Receptor 9 agonist) in combination with ipilimumab (manufactured by Bristol-Myers Squibb) demonstrating an overall response rate (ORR) of 44% in melanoma patients refractory.

Key Findings

  • Nine patients were treated at the Recommended Phase 2 Dose (RP2D) of 8 mg IMO-2125 (in combination with ipilimumab)
  • Confirmed RECIST v1.1 responses (including 1 Complete Response (CR) ≥ 1 year) were observed in 4 of these 9 subjects (44%);
  • Overall 6 patients out of 9 treated at the RP2D (67%) experienced disease control (CR, PR, or durable SD);
  • A RECIST v1.1 PR of > 1 year duration is ongoing in a patient treated with IMO-2125 4 mg (in combination with ipilimumab);
  • IMO-2125 in combination with ipilimumab is tolerable at all dose levels studied
  • IMO-2125 was safely administered via deep injection (using interventional radiology guidance) in patients lacking superficially accessible disease for injection
  • Dose escalation with IMO-2125 and pembrolizumab is ongoing; one patient has an ongoing PR by RECIST (v1.1), and;
  • An abstract highlighting translational findings from the trial has been accepted as an oral presentation for the upcoming Society for Immunotherapy of Cancer (SITC) meeting in November.

“The majority of patients with solid tumors do not respond to anti-PD-1 therapy and the published response rate to ipilimumab alone in anti-PD-1 refractory melanoma is only10-13%; to be seeing 6 out of 9 patients experiencing clear disease control is extremely exciting,” stated Adi Diab, M.D., Lead Trial Investigator, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas, MD Anderson Cancer Center.

“Based on these positive and encouraging response data in anti-PD-1 refractory melanoma, where the greatest need exists, we have expanded the target number of patients in the ongoing Phase 2 expansion, including broadening eligibility to patients who have received prior ipilimumab,  including the ipilimumab/PD-1 inhibitor combination,” stated Joanna Horobin, M.B., Ch.B., Idera’s Chief Medical Officer.  “We plan to start a Phase 3 trial in patients with PD-1 refractory melanoma in the first quarter of 2018.  Preparations are well-underway for this global initiative which is addressing a major unmet need in melanoma. We are very encouraged by the enthusiasm of investigators to participate in the Phase 3 study.”

Shares of Idera are currently trading at $2.18, up $0.23 or 12%. IDRA has a 1-year high of $3.33 and a 1-year low of $1.30. The stock’s 50-day moving average is $1.84 and its 200-day moving average is $1.93.

Idera Pharmaceuticals, Inc. is a clinical stage biotechnology company, which is engaged in discovery, development and commercialization of novel oligonucleotide therapeutics for oncology and rare diseases. The company uses two distinct proprietary drug discovery technology platforms to design and develop drug candidates: Toll-like receptor targeting technology and third-generation antisense technology.