Idera Pharmaceuticals Inc (NASDAQ:IDRA) reported that the U.S. FDA has granted orphan drug status for ‘IMO-2125’, an agonist of endosomal TLR 9 for the cure of melanoma phases IIb to IV. The company is currently performing the Phase II part of the ipilimumab combination arm of its Phase 1/2 clinical study of intratumoral ‘IMO-2125’ in people with ‘anti-PD-1’ refractory metastatic melanoma.
The goals of the current study are to assess IMO-2125’s tolerability, clinical activity and safety. Idera anticipates to close registration of the Phase II multicenter study in 2H2017 with ORR data available in the Q1 2018. The firm has filed an abstract to offer an update of clinical results from the current study at the ESMO Congress being conducted in September, in Spain.
Joanna Horobin, the Chief Medical Officer of Idera, reported that the Orphan Drug status bestowed by the FDA, showcases another vital step in the advancement of IMO-2125. A considerable proportion of people with metastatic melanoma don’t gain from anti-PD-1 treatment.
For PD-1 refractory melanoma patients, ipilimumab provides a modest gain with an ORR of 10-13%1,2. Idera objective is to considerably enhance on this via the combination of IMO-2125 and ipilimumab. They are increasingly inspired with the report seen to date and anticipate to offering their next clinical data update.
Idera is also registering a second arm in the Phase-1/2 clinical study in people with PD-1 refractory melanoma to evaluate the combination of pembrolizumab and IMO-2125 which is presently in the dose escalation stage. Besides this clinical trial, the firm recently commenced a study of ‘IMO-2125’ monotherapy targeting refractory solid tumors. Orphan Drug Designation is granted to drugs intended for the cure of a rare ailment that affects not more than 200,000 inhabitants in the United States.
In the last trading session, the stock price of Idera gained more than 3% to close the day at $1.82.