IDRAIdera Pharmaceuticals Inc (NASDAQ:IDRA) is reporting translational data supporting the mechanism of action of intratumoral IMO-2125, a Toll-like receptor (TLR) 9 agonist from the ongoing Phase 1 dose escalating clinical trial.  In this trial, IMO-2125 is being evaluated in combination with ipilimumab for treatment of patients with metastatic melanoma with disease that is refractory to anti-PD-1 inhibitors, and have minimal options and low expectation of clinical response with ipilimumab treatment alone. Taken together, the previously reported early clinical responses and the supporting mechanism of action translational data being presented today, indicate that intratumoral IMO-2125 is a potent agent for the stimulation of the tumor microenvironment.

In the oral presentation at the 2016 Society for Immunotherapy of Cancer Annual Meeting (SITC), entitled “Reactivating the anti-tumor immune response by targeting innate and adaptive immunity in a phase I/II study of intratumoral IMO-2125 in combination with systemic ipilimumab in patients with anti-PD-1 refractory metastatic melanoma,” Cara Haymaker, Ph.D., from the University of Texas, MD Anderson Cancer Center, presented an overview of the modulation of the tumor microenvironment through the unique mechanism of action of intratumoral IMO-2125 and provided an update on the initial findings of the translational data through the first cohorts of the trial.  Immunological analysis of the biopsy taken from the lesion injected with IMO-2125 showed rapid dendritic cell maturation which is a critical first step in the induction of the immune cascade within the tumor microenvironment.  During the treatment period, T-cell expansion and activation and importantly, immune infiltration was observed in the biopsied distant lesions of the responding patients, demonstrating the abscopal effect.

From a clinical perspective, through all dosing cohorts tested to date, no dose-limiting toxicity has been seen.  Preliminary clinical activity is also encouraging in this population with disease that is refractory to PD-1 inhibitors as 3 responses (including one CR) have already been recorded.  The trial continues to dose escalate and enrollment into the planned anti-PD-1 inhibitor combination arm has also commenced.

“We hypothesized that the intratumoral injection of IMO-2125 into a single tumor lesion would stimulate dendritic cells to produce interferon and the downstream immune cascade in the tumor microenvironment, resulting in the recruitment and activation of tumor-killing T-cells in both the injected and non-injected tumors,” said Joanna Horobin, M.B., Ch.B., Idera’s Chief Medical Officer.  “When combined with a systemic checkpoint inhibitor, this change in the tumor microenvironment was expected to affect tumor responses in both injected and distant tumors.  Today Dr. Haymaker presented analyses of serial biopsies from the tumors of patients with anti-PD-1 refractory melanoma in our ongoing phase 1 dose escalation trial of intratumoral IMO-2125 which clearly demonstrated these beneficial changes in the tumor microenvironment, essentially turning “cold” tumors “hot” in responding patients. We are thrilled to see what we believe to be, the clear translation of our hypothesis in patients.  Moreover, in three patients the investigator has reported substantial tumor shrinkage with 2 partial and one complete response.” (Original Source)

Shares of Idera Pharmaceuticals are currently trading at $1.87, up $0.03 or 1.91%. IDRA has a 1-year high of $4.42 and a 1-year low of $1.19. The stock’s 50-day moving average is $2.22 and its 200-day moving average is $1.79.

On the ratings front, IDRA stock has been the subject of a number of recent research reports. In a report issued on October 28, Cowen analyst Boris Peaker reiterated a Buy rating on IDRA. Separately, on August 25, Wedbush’s Heather Behanna reiterated a Buy rating on the stock and has a price target of $6.00.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Boris Peaker and Heather Behanna have a yearly average return of 9.4% and a loss of 4.9% respectively. Peaker has a success rate of 43% and is ranked #307 out of 4200 analysts, while Behanna has a success rate of 33% and is ranked #3563.

Idera Pharmaceuticals, Inc. is a clinical stage biotechnology company, which is engaged in discovery, development and commercialization of novel nucleic acid therapeutics to treat patients with serious and life-threatening diseases. Idera’s immunotherapy approach is based on the modulation of toll-like receptors (TLRs) while its third-generation antisense technology is designed to inhibit the production of disease-associated proteins by targeting RNA.