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?).
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
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 come first (assuming a breakthrough filing with Phase 2 data), ICT-107 could reduce the market segment for 1st-line rindopepimut significantly (e.g., from 33% down to 8-16% if HLA1/A2 positivity is as frequent in EGFRvIII+ patients as in an all-comer population). Also the 2nd-line GBM population available to rindo should be much smaller as ICT-107 will reduce the prevalent population of recGBM patients very effectively. If then ICT-121 proves to be effective in 2nd-line this (already reduced) market segment will become very competitive, too. But this program is farther behind. So that a positive IMUC development seems to be to the detriment of rindopepimut's market prospects.
In terms of recruitment efficiency, there should be no interference. ACT IV is fully recruited any day now and ICT-121 as a single center Phase 1 should not interfere with all the many reACT trial centers.
Long-term: If both principles (dendritic vaccines ICTxxx and peptide vaccine rindopepimut) are shown to be active principles in GBM, head-to-head or combination trials will be a topic for discussion, also treatment regimen to spare patients from radio chemotherapy. But that discussion is a number of years out into the future.
Good response! I would point out that anybody buying CLDX for only the investigational GBM drug is missing the much larger potential moving forward with their pipeline. Secondly, because ICT-107 is a targeted treatment with a diagnostic identifier makes this POSITIVE for IMUC as this is the direction of current science. All products should benefit these patients. Cross resistance issues would need to be investigated though