Thanks Paladin and JR. Clear explanation for new investors here. BB in at essentially 3.99 on millions of PRE-PAID warrants. Also, the agreement, if you dig back far enough, is that they are automatically exercised in any buyout. Confidence....and the 2 BOD seats staring straight at the open-label results and the GSO potential.
WM data. One gene, many diseases. And they've started DLBCL and Dermo based on this ONE gene. AND, they've paid millions to diagnose this ONE gene. This a sharply focused company with the best scientists, the best investors, and the best management. And all have dumped millions into it. One word --- open-label. You don't start 2 additional trials if you think WM will fail in killing this gene.
Conclusions: IMO-8400 is a mutation-targeted therapy in development for the treatment of patients with relapsed or refractory WM. In an ongoing Phase 1/2 clinical trial in WM, IMO-8400 has been generally well tolerated and has demonstrated preliminary evidence of clinical activity. Safety results support continued evaluation of IMO-8400 at 2.4 mg/kg/week in this patient population.
Preliminary evidence of clinical activity for IMO-8400 has been observed in all dose cohorts. In June 2015, an independent Data Review Committee reviewed 4-week safety data from the highest dose cohort and agreed that 2.4 mg/kg was safe for further evaluation. Safety, pharmacokinetics and preliminary activity for all three dose cohorts will be presented.
Introduction: Waldenström’s macroglobulinemia (WM) is a rare, indolent B-cell lymphoma characterized by lymphoplasmacytic cell infiltration of bone marrow and elevated serum levels of immunoglobulin M (IgM) protein. Despite recent advances in treatment the disease relapses in most patients. About 90% of WM patients harbor the MYD88 L265P oncogenic mutation. MYD88 is an adapter protein in the Toll-like receptor (TLR) pathway. The MYD88 L265P oncoprotein has been shown to amplify TLR 7 and 9 signaling, leading to downstream activation of NF-κB and cytokine signaling pathways that promote tumor cell survival and proliferation (Lim, AACR 2013). IMO-8400 is an investigational oligonucleotide antagonist of endosomal TLRs 7, 8 and 9. In preclinical studies in a human cell line and animal models of WM, IMO-8400 inhibited key cell signaling pathways, including NF-κB, BTK, STAT-3 and IRAK-4, and inhibited tumor growth and tumor IgM production. In Phase 1 and 2 clinical trials in healthy subjects (N=30) and in patients with autoimmune disease (N=35), IMO-8400 was generally well tolerated and demonstrated evidence of clinical activity. Based on these data, we initiated a Phase 1/2 clinical trial of IMO-8400 in WM, the first study of a drug candidate specifically targeting the MYD88 L265P mutation.
Feel for my fellow IDRA longs. The crooks should be arrested and tossed in jail. They saw all the retail dollars and are stealing as much as they can. My DD on it isn't as deep as the rest of you guys. If the science is as good as you say, this is getting close to a buy. Got a feeling they're gonna sweat retail for the foreseeable future, like they've done IDRA. GL AVXL longs. IDRA is priming for nice run IMHO.