Absolutely agree! CLDX has a phenomenal pipeline. Lot's of innovative stuff to be excited about. My intention in this post, however, was only to compare the GBM programs of the two companies (see headline). But thanks, Tyco, for reminding everybody of the richness of CLDX' portfolio (hence, their valuation!).
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.
I disagree. The facts (clinical trial operational performance, clinical endpoints, product features, logistics etc.) do not speak for NWBio. Please, see my post from yesterday under the heading "IMUC vs. NWBio".
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
IMUC has the potential of a game changer and if ICT-107 ph2 is positive it will make recruitment into the NWBio even more sluggish. NWBio would have to take their trial from Western Europe further east - with all the costs and risks this entails.
Again: I would not bet my money on NWBio...
It's excellent and - let's not forget - it was deemed spectacular enough to be given an oral presentation by the SNO program committee. Cheers to all longs!
If effective in such late stage patient population (reACT, bev-refractory), it is nearly guaranteed to be highly effective in first-line, too. Good news for CLDX !!
"Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer" - here is in short what I could gather from all press releases pertaining to this trial and from SEC filings by NWBio:
Q4 2006: Trial starts as an open, randomized phase II, n=140; first IRB approval at Henry Ford Hospital, Detroit in Nov 2006. Study start date (acc. to clinicaltrialsdotgov): Dec 2006.
Q1 2007: First two patients enrolled undergo surgery in Detroit; UCLA joins as the second trial center
2008: Trial halted, because too many patients randomized to the control arm (no active treatment) withdraw. NWBio designs a placebo procedure in response.
Q1 2009: Trial re-starts as a randomized, placebo-controlled phase II trial; n=240
Q1 2011: 31 US sites open and active; 33 patients enrolled. May 2011: co re-confirms the number 33.
May 2012: 41 US sites open and active; no new patient numbers. Trial is up-graded to a phase III, n increased to "up to" 300 patients. Planned expansion to Europe and an interim analysis for efficacy (no mention of the trigger for this analysis).
Oct 31, 2012: S1 SEC filing, 41 US sites open and active, plan to open a total of "80 or more sites in both the US and Europe". No up-date of patient numbers.
Feb, 2013: Still - only - 41 sites open, "poised to begin recruiting in the UK"… Finally, PAREXEL engaged as global CRO to manage the trial
Sep, 2013: German authority (PEI) approves trial to start recruiting in Germany with substantial changes to the protocol.
You may consider IMUC a speculative investment and I wouldn't argue against that. However, their randomized, placebo-controlled phase II trial is fully recruited since early Sept 2012 and we simply have to wait for it to mature and produce the overall survival data sometime soon (Q4'13, Q1'14). NWBio keep everyone in the dark about the true performance of their trial, true accrual numbers. It seems fair, however, to infer from their public statements that they are far from completing recruitment, left aside producing meaningful results….
IMUC may be speculative, but, at least, we reach the value inflection point any day now. With NWBio, you don't know where they stand at present and results from this trial are out into indefinite future. IMUC, if positive, runs a fair chance even to go straight into filing.