Idera Pharmaceuticals, Inc., a clinical-stage biotechnology company developing novel therapeutics for orphan patient populations with B-cell lymphomas and autoimmune diseases, has entered into an agreement with Abbott, the global healthcare company, for the development of an in vitro companion diagnostic test for use in Idera’s clinical development programmes to treat certain genetically defined forms of B-cell lymphoma with IMO-8400.
Under the agreement, Abbott will develop a test utilizing polymerase chain reaction (PCR) technology to identify the presence of the M YD88 L265P oncogenic mutation in tumour biopsy samples with high sensitivity and specificity. This mutation, which can be identified in approximately 90% of patients with Waldenström’s macroglobulinemia and approximately 30% of patients with the ABC sub-type of diffuse large B-cell lymphoma, plays a key role in activating the Toll-like receptor (TLR) pathways targeted by Idera’s lead drug candidate, IMO- 8400.
“Research by Idera and by independent investigators has established TLR antagonism as a potentially promising and novel therapeutic approach for patients with B-cell malignancies harboring the MYD88 L265P mutation,” said Lou Brenner, senior vice president and chief medical officer of Idera Pharmaceutical s. “This companion diagnostic will be an important tool for the clinical community in evaluating whether their patients are potential candidates for IMO-8400 therapy for the treatment of these genetically defined forms of B-cell lymphoma. We are excited about the opportunity to partner with Abbott, a leader in companion diagnostics, as part of Idera’s mutation- targeted development program for IMO-8400 in B-cell lymphomas.”
Idera’s Toll-like receptor (TLR) antagonist drug candidates have been created using a proprietary chemistry-based drug discovery platform. IMO-8400 is a first-in-class synthetic oligonucleotide- based antagonist of TLRs 7, 8, and 9. In April 2014, Idera presented preclinical data at the American Association for Cancer Research Annual Meeting demonstrating the ability of IMO- 8400 to inhibit the survival and proliferation of human B-cell lymphoma cells harboring the oncogenic MYD88 L265P genetic mutation. IMO-8400 also has show n activity in preclinical studies of autoimmune diseases, including psoriasis, lupus, and arthritis. IMO-8400 has been well-tolerated in a Phase 1 trial in 42 healthy s ubjects at single and multiple escalating doses up to 0.6 mg/kg for four weeks, and has shown inhibition of immune responses mediated by TLRs 7, 8, and 9. In March 2014, Idera announced top-line data from an ongoing phase 2 trial that showed evidence of clinical activity in patients with psoriasis who were treated with IMO-8400 at doses of up to 0.3 mg/kg/week for 12 weeks. Idera is pursuing clini al development of IMO- 8400 in genetically defined forms of B- cell lymphoma, including Waldenström’s macroglobulinemia and diffuse large B-cell lymphoma, and in orphan autoimmune diseases, including polymyositis and dermatomyositis.