Idera Pharmaceuticals Inc. (NASDAQ: IDRA) made a strong push in Monday’s session following the presentation of its clinical data over the weekend. The company presented initial clinical data from its ongoing Phase 1/2 clinical trial for IMO-8400, a Toll-like receptor 7, 8 and 9 antagonist, being evaluated for the treatment of patients with relapsed or refractory Waldenström’s macroglobulinemia.
The primary objectives of the study were to assess safety and tolerability. Secondary objectives were to assess pharmacokinetic and clinical activity and define the optimal dose for further clinical evaluation. In addition to clinical treatment parameters, cytokine levels were analyzed as an exploratory endpoint in the trial.
These results from the study provided evidence that IMO-8400 has clinical activity and is well tolerated at all dose levels studied. As a result, the data gave the first clinical evidence supporting the inhibition of the TLR pathway as a potential therapeutic approach for B-cell malignancies characterized by the MYD88 L265P oncogenic mutation.
Vincent Milano, CEO of Idera, said:
Our clinical trial in Waldenström’s Macroglobulinemia represents the first step in our understanding of the potential role that TLR antagonism could play in B-cell malignancies, specifically in those harboring the MYD88-L265P oncogenic mutation which is highly prevalent in Waldenström’s Macroglobulinemia. We are pleased that the initial results from this ongoing trial met our objectives in determining safety and tolerability, as well as clinical activity of IMO-8400 in this patient population. We are further encouraged that the safety profile seen to date will enable us to expand this study to evaluate higher dosing levels of IMO-8400.
So far in 2015, Idera has underperformed the market, with the stock down almost 14% year to date. However, over the past 52 weeks the stock is only down about 6%.
Shares of Idera were last seen trading up over 8% at $4.12, with a consensus analyst price target of $6.50 and a 52-week trading range of $2.27 to $5.48.