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ImmunoCellular Therapeutics, Ltd. Message Board

  • fansteman fansteman Nov 25, 2013 11:40 AM Flag

    CLDX' vs. IMUC's GBM-programs

    People on this Board raised an interesting question: Any interference between these two programs? If so, how?

    CLDX' rindopepimut targets EGFRvIII-Marker+ patients, about 1/3 of all 1st-line GBM. It is a peptide vaccine, given intra-dermally. CLDX have an on-going trial in recurrent GBM, called reACT, and a 1st-line trial, called ACT IV. Both trials are actively recruiting. ACT IV is expected to be fully recruited by year end 2013, a first scheduled interim-analysis mid-2014, a second scheduled interim end of 2014. reACT was expanded based on the data presented at SNO. This trial has a tricky design: Group 1 is a randomization of bevacizumab (AVASTIN)-naive patients into rindo+GM-CSF+bev and "placebo"+bev while Group 2 gets rindo+GM-CSF+bev (all bev-failing patients).

    IMUC has two GBM-programs: ICT-107 is a dendritic cell vaccine given in conjunction with standard radio chemotherapy, applied intra-dermally, and is in Phase 2. The target patient population has to be HLA1/A2-positive, about 50-75% of 1st-line GBM. The trial completed recruitment in September 2012. Results are due any time now (CEO always speaks of Q4'13 or Q1'14). The company presented these spectacular Phase 1 long-term follow-up results on PFS and OS which seem to bode well for their Phase 2.

    Second IMUC GBM-program is with a CD133 targeted dendritic cell vaccine, ICT-121, in Phase 1, recruiting since mid-year, n=20, single-center. This target is particularly frequent in rec/ref GBM-patients, and the study is in 2nd-line patients only. I don't know (anybody?) whether also this trial is only in HLA1/A2-positive patients and whether that will be a selection criteria for further development and what the frequency of this biomarker is in 2nd-line GBM (same as 1st-line? different? how different?).

    Interferences?

    Target patient population: ICT-107 targets 50-75% of all 1st-line GBM patients. If their Phase 2 results are overwhelmingly positive and since they

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