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Celldex Therapeutics, Inc. Message Board

  • agogoidbe agogoidbe Jul 1, 2013 7:16 PM Flag

    CDX-1135 for a very rare disease; What's the Catch?!

    Dense deposit disease (DDD) seems to be a very rare disease; they are enrolling only 5 people for this phase. For sure they are spending a lot of resources for such a rare orphan disease. CLDX doesn't do things at random (Una did, but she's gone). What major diseases share similar characteristics/similarities... Could CLDX be paving the way for something bigger? An Alzheimer's vaccine maybe?

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    • agogoidbe,

      CLDX doesn't need other "major diseases" for CDX-1135 to be a commercial success. For a rare orphan disease indication, CLDX could charge anywhere between $250,000-$750,000 per treatment. They only need a one or two person sales team. Look what Soliris did for Alexion.

      Bladerunner

      Sentiment: Strong Buy

    • It's for proof of concept. CDX-1135 could be huge down the road.
      CDX-1135 (formerly TP10): We have been developing immunotherapeutics that inhibit a part of the immune system called the complement system. The complement system is a series of proteins that are important initiators of the body’s acute inflammatory response against disease, infection and injury. Excessive complement activation also plays a role in some persistent inflammatory conditions. Our lead compound, CDX-1135, a soluble form of naturally occurring Complement Receptor 1, has effectively shown to inhibit the activation of the complement cascade in animal models and in human clinical trials. We believe that regulating the complement system could have therapeutic and prophylactic applications in several acute and chronic conditions, including organ transplantation, multiple sclerosis, rheumatoid arthritis, age-related macular degeneration (“AMD”), atypical Hemolytic Uremic Syndrome (“aHUS”) and myasthenia gravis. We are currently defining the most appropriate clinical development path for CDX-1135 and are focusing on rare disease conditions of unregulated complement activation as the fastest route to FDA approval.

      • 1 Reply to weightbayou
      • Thanks for reminding us.

        "We believe that regulating the complement system could have therapeutic and prophylactic applications in several acute and chronic conditions, including organ transplantation, multiple sclerosis, rheumatoid arthritis, age-related macular degeneration (“AMD”), atypical Hemolytic Uremic Syndrome (“aHUS”) and myasthenia gravis. We are currently defining the most appropriate clinical development path for CDX-1135 and are focusing on rare disease conditions of unregulated complement activation as the fastest route to FDA approval."

        So not only s not random choice, it is of course extremely logical one. The faster route to expedited approval/breakthrough status and the systemic ramifications of its potential applicability to these other indications/conditions, well what can one say? Once again this is not just a immunotherapeutic single application or drug but the designing a different type of engine, one that does NOT currently exist or with any measure of success let alone multiple applications with respect to regulating the complement system. Billions

 
CLDX
3.78Aug 23 4:00 PMEDT