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Celldex Therapeutics, Inc. Message Board

  • bladerunner1717 bladerunner1717 Jul 5, 2013 12:30 AM Flag

    What CLDX is working on to allay criticism

    The two major criticisms of CLDX coming from seasoned biotech investors is that CLDX doesn't have a good assay for GPNMB expression (011 breast cancer trial) and that CLDX is moving up many lines of therapy for the Phase III, which is not justified by the Phase II's. I've just learned from my sources that CLDX is working on a much-refined assay for GPNMB. The second criticism I personally don't believe is valid. If 011 works in breast cancer, I think it has a good chance of out-perfoming Xeloda, the comparator arm. Yes, the trial is more risky (and there is no SPA), but moving up to front-line therapy potentially carries with it huge rewards.

    Bladerunner

    Sentiment: Strong Buy

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    • If the GPNMB assay is a biopsy DNA/RNA test, then CLDX is set. The Supreme Court's decision on intellectual property and DNA makes a lot of these assays easier to develop/license/obtain for companies like CLDX.

      Sentiment: Strong Buy

    • That is absurd. Phase IIb demonstrated high GPNMB in TNMB to have 34% PFS vs zero in the IC arm (which included everything under the sun). Also HIgh GPNMB alone demonstrated more than a 2 to 1 statistical difference in PFS

    • "I've just learned from my sources that CLDX is working on a much-refined assay for GPNMB. "
      Will that delay the Phase III trial even longer? The current assay is not good enough?

      "but moving up to front-line therapy"
      The intended trial does move up the treatment sequence, but it is still not front-line.

      • 1 Reply to raulbog9
      • raulbog,

        I don't think the refining of the assay will delay the start of the Phase III. Results won't be reported until 2015, but there will be a safety readout at 90 events in late 2014.

        You may be right about the Phase III not being front-line, because I think Xeloda is approved in second-line. I need to check that again.

        Bladerunner

        Sentiment: Strong Buy

    • temporal@prodigy.net temporal Jul 5, 2013 1:46 AM Flag

      I've not heard either of these criticisms. What are the sources?

      Sentiment: Strong Buy

      • 1 Reply to temporal
      • Temporal,

        These criticisms come from biotech investment newsletters from reputable people. I think it's always good to look at my investments from all sides. And, frankly, shorts tend to be smarter than longs.. But the bear case on CLDX is not convincing, IMO. Furthermore, the bears underestimate the value of CDX-1135 and especially that of CDX-1127. If CDX-1127 results are positive, even in early-stage trials, and if the Market perception is that CDX-1127 can be usefully combined with the PD-1 inhibitors, then the sky is the limit for CLDX.

        Bladerunner

        Sentiment: Strong Buy

 
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