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December 4, 2013
07:32 EDTIDRAIdera Pharmaceuticals opens enrollment for Phase 1/2 IMO-8400 trial
Idera Pharmaceuticals announced that enrollment is open for a Phase 1/2 clinical trial of IMO-8400 in patients with Waldenström’s macroglobulinemia, following acceptance of its Investigational New Drug application by the U.S. Food and Drug Administration. The objectives of the trial are to evaluate the compound’s safety, tolerability, and potential clinical activity. The IND application for the Phase 1/2 trial was supported by preclinical research conducted by Idera, which the company intends to present at one or more scientific meetings in 2014. The IND was further supported by clinical safety data from a Phase 1 trial of IMO-8400, in which dosages up to 0.6 mg/kg were well-tolerated and inhibited immune responses mediated through TLR7, TLR8, and TLR9. The Phase 1/2 clinical trial will enroll patients with Waldenström’s macroglobulinemia who have a history of relapse or failure to respond to one or more prior therapies. The protocol includes three dose-escalation cohorts to evaluate the safety and tolerability of IMO-8400 and a provision to expand enrollment at selected dose levels to allow further evaluation of clinical activity. Idera expects to enroll a total of approximately 30 patients. Idera previously announced that it intends to submit a protocol to the FDA to conduct a Phase 1/2 trial in patients with diffuse large B-cell lymphoma in the first quarter of 2014.
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April 7, 2014
16:13 EDTIDRAIdera says preclinical data shows inhibition of lymphoma cells
Idera Pharmaceuticals presented new preclinical data demonstrating the ability of its Toll-like receptor antagonist, IMO-8400, to inhibit the survival and proliferation of B-cell lymphoma cells harboring the oncogenic MYD88 L265P genetic mutation. These data add to the research which supports the company’s efforts to develop IMO-8400 for the treatment of genetically defined forms of B-cell lymphoma. The data build upon reports from independent investigators and provide additional evidence that the MYD88 L265P mutation, which is present in certain B-cell lymphomas, results in over-activation of TLR7 and TLR9 mediated signaling. Idera has opened enrollment in a Phase 1/2 trial of IMO-8400 designed to evaluate IMO-8400’s safety, tolerability and potential clinical activity in patients with Waldenstrom’s macroglobulinemia who are refractory to prior therapies. The company anticipates that patient treatment in this trial will begin in Q2. Idera has also submitted a separate protocol to the U.S. FDA to conduct a Phase 1/2 trial in patients with DLBCL who harbor the MYD88 L265P mutation.

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