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ImmunoCellular Therapeutics, Ltd. Message Board

  • fansteman fansteman Nov 23, 2012 5:13 AM Flag

    IMUC vs. NWBio

    As this topic keeps coming up time and again (recent posts by bloguy and johncarpenter etc), consider the facts:

    ICT-107 needs one single apheresis per patient to generate enough dendritic cells for up to 30 doses. IMUC pulses the patients' apheresis product (PBMCs) with synthetic (!!) stem cell (!!) antigens. NWBio needs multiple aphereses plus autologous tumor tissue from the same patient. Much more cumbersome, much more costly, much less reliable as a procedure.

    Take clinical trial performance as indicative of future market acceptance and success: IMUC activated their randomized phase II trial in January 2011, had 25 active centers (some of the finest in GBM in the US) who enrolled a total of 278 patients by September 2012 (in Sept. 2011 they had 18 centers and 36 patients enrolled, in other words 242 patients enrolled within 12 months). NWBio started their trial as a phase II in Dec 2006, turned it into a phase III in summer 2012 are still trying to recruit new centers (41 open and recruiting by May 2012, aiming for "at least 60" by end Q3'12 - no news on achievement levels) to finally recruit a total of up to 300 patients (no status reports posted). IMUC recruited in 12 months more patients than NWBio in 6 years (or 70 months).

    IMUC is about to make it to the finishing line with mature OS data in 2013 while NWBio's finishing line keeps moving out into the future...

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    • Synthetic antigens? I'm curious, and I don't necessarily frown on this sort of technology. As a matter of fact, I think this is a large part of the immunological future. How are they produced? Do they generate them like VLP's?

      Sentiment: Buy

    • If anyone has bothered to look at the NWBO S-1, could they let us know the current enrollment? That is very important information.

      • 2 Replies to nhyujm6
      • Yes, I have. Strangely, they only give information about the number of clinical trial sites involved (to date in the US and planned overseas). No patient numbers!

        I also went through their entire thesaurus of press releases related to the trial: In short, the trial posted first in Dec 2006 on clinicaltrialsdotgov, started as an open, randomized phase II with no placebo and a targeted sample size of 140 patients. In a press release dated Feb 13, 2007 they announce the first two patients enrolled undergoing surgery in Detroit. On March 7, 2007 UCLA was added as a second trial site, nine further sites pending. Then, sometime later (could not establish the exact time nor the number of patients enrolled until the trial was halted) the trial had to be stopped due to large number of patients dropping off who had been randomized to no active treatment. They went back to design a placebo process and redesigned the trial as a placebo-controlled phase II with n=240 pats, resuming activities in 2009. On Jan 24, 2011 (about 2 years after the trial had recommenced as a placebo trial) the company announced that "to date" 13 sites are open and active with a total of 33 patients enrolled. In May, four months later, in another press release NWBio announces the addition of further sites and reconfirms the 33 patients enrolled at that time. In a press release from May 25, 2011 NWBio announces the "acceleration" of the opening of new trial sites expecting to have "a total of 10 clinical trial sites for new (sic!) enrollment...within this calendar quarter" and "5 further sites are anticipated to be added in the 3rd quarter". On Aug 4, 2011 "Now 12 sites across the US open and active" (which appears to be in contradiction to the number given at the beginning of 2011, imho). Oct 6, 2011: 17 sites open and active, expecting to have 25 sites by year end. Jan 9, 2012 25 open and active sites, expecting to have at least 30 by end Q1/2012. Feb 23, 2012: 30 US sites open and active, expecting at least 40 open and enrolling by the end of Q2/2012. May 17, 2012: 41 US sites open and recruiting, expecting to have at least 60 by end Q3/2012. In this amendment they also report on the up-grade to a phase III trial with n=300 (up to) and an interim analysis for efficacy (no information as to what triggers this interim). Aug 23, 2012: Still 41 US sites, looking at Europe (particularly UK and Germany) for the addition of further trial sites.

        In an S1 SEC filing dated Oct 31, 2012 they still have 41 US centers open and active, do not give patient numbers and state the ambition to go up to "80 or more" centers in the US and Europe.

      • You can go and enter 00045968 in the search box. Then make sure you select show display options and enter any criteria that may interest you. You can do the same for imuc, enter 01280552.

        Sentiment: Hold

    • Interesting though that NWBio's results are inline with IMUC's phase 1. I looked at Northwest 1 time in the past and decided not to invest. It appears it's owned 50% by the CEO (which is a huge vote of confidence), but has debt issues for which they will dilute. There is also MB chatter about NASDAQ uplisting, which I believe is just chatter. I'm not too familiar with the comments you made above about lack of press release, moving the finish line, etc, but if true, that's pretty disconcerting. Question though: any benefit in investing in both? Or do you just invest in who you think is the best company with the best product (at the risk of being wrong)? IMUC is one of my two favorite biotech's, despite management's recent debacles.. GL...

      Sentiment: Buy

      • 2 Replies to alexp1112
      • Again: My impression is, if NWBio ever made it to the finishing line, their product does not look competitive even if at par with IMUC in regards to efficacy (which they won't be: ICT-107 phase II PE is mOS while DCVax phase III PE is mPFS). Tumor tissue logistics is a big obstacle - see Provenge - plus the additional costs and additional aphereses etc. But my biggest concern remains their phase III trial performance... A clinical trial running for more than 6 years and still recruiting (new centers and patients) is worrying for many reasons.

        My only other bet in the glioma space besides IMUC is Celldex (CLDX). Looks very promising in a sub-population of EGFRvIII-mutation positive patients (about 30% of all first-line GBM). In addition, they have a nicely diversified clinical portfolio in different indications... Take a look, Alexp!

      • I own them both!

        Sentiment: Buy

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