Following are the updates on clinical development programs:
ILLUMINATE 204 – Phase 1/2 Trial of IMO-2125 in Combination with Ipilimumab or Pembrolizumab in patients with PD-1 refractory metastatic melanoma: Enrolled 21 patients at 8mg (RP2D) dose with ipilimumab.
In pembrolizumab combination arm of the trial, phase 1 dose escalation continues into the last dosing cohort (32mg).
ILLUMINATE 101 – Phase 1b Trial of Intratumoral IMO-2125 Monotherapy in patients with refractory solid tumors: Completed enrollment of 11 patients in first cohort with 8mg dose of IMO-2125.
Advanced to enrollment of second cohort (9 patients treated with 16mg dose of IMO-2125).
ILLUMINATE 301 – Phase 3 Trial of IMO-2125 in Combination with Ipilimumab in patients with PD-1 refractory metastatic melanoma: Trial planned in Q1 enrolling 300 patients with overall response rate and overall survival as trial endpoints. FDA granted Fast Track Designation for IMO-2125 in combination with ipilimumab in Q4 2017.
PIONEER – Phase 2 Trial data of IMO-8400 in adult patients with Dermatomyositis is expected in Q2.
IDRA – 008 Development Activities: Pre-clinical study in Cyno-model comparing IDRA-008 to Volanesorsen is expected to readout during Q1.
Corporate Updates: On January 4, reverse stock split of not less than 1-for-4 and not more than 1-for-8 approved.
Shares are up 3% premarket on light volume.
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