Idera Pharmaceuticals Inc (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, announced that the company has entered into a strategic clinical research alliance with The University of Texas MD Anderson Cancer Center to advance clinical development of intratumoral TLR9 agonist in combination with checkpoint inhibitors. IMO-2125 is a TLR9 agonist which has been evaluated subcutaneously in over 80 human subjects, was well tolerated, and was shown to induce immune responses.
The company intends to initiate the first trial of the research alliance, a Phase 1/2 study to assess the safety and efficacy of Intratumoral IMO-2125 in combination with ipilimumab (a CTLA4 antibody) in patients with metastatic melanoma. In this trial, escalating doses of IMO-2125 will be administered intratumorally into a lesion, with a standard dosing regimen of ipilimumab. The primary objectives of the trial will be to determine the maximum tolerated dose (MTD) and characterize the dose-limiting toxicities (DLTs) of IMO-2125 when administered intratumorally in combination with ipilimumab, as well as to determine the efficacy of the combination utilizing the immune-related response criteria (irRC). The company has already filed and received FDA feedback to a Pre-Investigational New Drug Application (PIND) for IMO-2125 and intends to submit an Investigational New Drug application (IND) and initiate the clinical study in the second half of this year. The trial will enroll approximately 45 patients. The company expects data to be available in 2016. The study will be led by Adi Diab, MD, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, MD Anderson. Additional trials as part of the broader, clinical research alliance are currently in the planning stages.
“This type of clinical research alliance is important to MD Anderson’s work toward eliminating cancer,” said Patrick Hwu, M.D., division head, Cancer Medicine at MD Anderson. “The study to be headed by Dr. Diab will add to our overall efforts in finding new therapies for our patients.”
“Being chosen as a strategic research alliance partner by MD Anderson, a world-leading cancer research center to advance the clinical development of intratumoral TLR9 agonists in combination with check-point inhibitors is an important step forward for Idera’s oncology program. We look forward to evaluating in the clinical setting if our targeted intratumoral approach can meaningfully improve patient outcomes,” stated Vincent Milano, Chief Executive Officer of Idera Pharmaceuticals. “The pre-clinical data we presented at theAmerican Association for Cancer Research (AACR) Immunotherapy conference in December demonstrated that the combination of intratumoral TLR9 agonist and systemically administered ipilimumab induced potent anti-tumor activity in both the treated and distant tumors and we look forward to seeing if we can replicate those results in the clinical setting.”(Original Source)
Shares of Idera Pharmaceuticals closed last Friday at $3.59 . IDRA has a 1-year high of $5.48 and a 1-year low of $1.94. The stock’s 50-day moving average is $3.18 and its 200-day moving average is $3.92.
Idera Pharmaceuticals Inc is a clinical stage biotechnology company.The Company is engaged in the discovery, development and commercialization of novel therapeutics for oncology and rare diseases.