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Exelixis, Inc. Message Board

wilderguide 177 posts  |  Last Activity: 2 hours 40 minutes ago Member since: Jan 13, 2011
  • wilderguide by wilderguide Apr 4, 2016 1:42 PM Flag

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    Cabo abstracts 1019, 4684, 4979... LBAs 226 & 274...
    Most interesting to me are 4684 & 4979. These are immune-directed studies that attempt to discern and explain Cabo impact on immune response and induced resistance to treatment. #4684 investigates Cabo dosage below recognizable toxicity and It's mechanisms of mitigating multi drug resistance. These studies appear to bode quite well for Cabo in combination with existing treatments, particularly wrt the suggestion of efficacy below the toxic threshold.

  • Reply to

    Adding more employees

    by clemcaldwell Apr 2, 2016 2:17 PM
    wilderguide wilderguide Apr 2, 2016 5:47 PM Flag

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    Thanks for posting this, Clem...
    EXEL is at an interesting corporate juncture - MMM, at the decisive crossroad of his career. This is the highest number of EXEL employees for many years, and the corporate momentum appears back on track following the COMET fiasco. However, I am always reminded of a joke from the Bush administration days that belies Murphy's Law regarding all the stuff that can go wrong, in which Secretary Rice has requested urgent audience with the President:
    Condoleeza: Mr President, we've just received word that 6 Brazilian troops were killed this morning in an early morning attack in Kabul. I think we need to issue a statement to the press.
    W: Oh my God, that's terrible news...!!!! (Cradling his head in a posture of grief...)
    Condoleeza: (A bit surprised...) Yes, Sir...it is. Are you up to it?
    W: Well, I guess maybe I should...but help me out here, Condoleeza...
    How many is a brazillion?

  • Reply to

    Cabo in myeloma

    by wilderguide Mar 30, 2016 8:07 PM
    wilderguide wilderguide Mar 31, 2016 3:15 PM Flag

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    I doubt the myeloma results will have any impact whatever on the significance of the METEOR results. One has virtually nothing to do with the other...
    JMO - I think a failed P1 study will go largely unnoticed in the bigger picture.

  • Reply to

    EMA CHMP Agenda - this week

    by wilderguide Mar 29, 2016 10:21 PM
    wilderguide wilderguide Mar 31, 2016 11:56 AM Flag

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    "I wonder if Ipsen had anything to do with...the agenda."
    Only the Devil can possibly know all the details. If one bad apple (read Shkreli) can taint the entire market perspective on biotech here in the States, who can really say what strength of political lobby a large pharma can bring to bear. Besides, Cabo has already been granted an accelerated assessment by the EMA. If we should see a positive opinion out of this week's meeting, the EC could deliver an MA as early as first week June - perhaps sooner. Ipsen will want sooner, as I think the MA transfer application can only take place after the MA has been granted. If you recall, the current MA holder for Cabo in Europe is TMC pharma. It'll be instructional to watch as this all shakes out.

  • Reply to

    Cabo in myeloma

    by wilderguide Mar 30, 2016 8:07 PM
    wilderguide wilderguide Mar 30, 2016 8:38 PM Flag

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    Thanks for posting this, jbird...

  • Reply to

    Cabo in myeloma

    by wilderguide Mar 30, 2016 8:07 PM
    wilderguide wilderguide Mar 30, 2016 8:23 PM Flag

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    For reference, I copied the following commentary from Nature that distinguishes between articles and letters - at least within their publishing purview:
    "Articles are original reports whose conclusions represent a substantial advance in understanding of an important problem and have immediate, far-reaching implications.
    Letters are short reports of original research focused on an outstanding finding whose importance means that it will be of interest to scientists in other fields."
    Food for thought...

  • wilderguide by wilderguide Mar 30, 2016 8:07 PM Flag

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    A letter published 3/28/16 in Blood Journal, co-authored by all participating oncodocs in both MM Cabo studies NCT01866293 & NCT01582295. Available by subscription only - no abstract is available. In the absence of a presentation, it's impossible to know what it's about, though I find it quite odd that this letter incorporates commentary from two different trial locations - MSKCC & MGH - each with its own trial protocols and in-house principal investigators. Any thoughts?

  • Reply to

    EMA CHMP Agenda - this week

    by wilderguide Mar 29, 2016 10:21 PM
    wilderguide wilderguide Mar 30, 2016 11:07 AM Flag

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    Importantly, the CHMP is only empowered to offer an opinion. The decision on whether to approve a marketing authorization must come from the European Commission, which coordinates on an unpublished calendar.While I expect the CHMP to issue a positive opinion at some point in time, it may require more than this one session. This meetings' highlights might be available as early as next week.
    Wrt lenvatinib in RCC, I expect the CHMP to require further data. The published successes are based on very small patient groups.

  • wilderguide by wilderguide Mar 29, 2016 10:21 PM Flag

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    Item 3.4.4 Cabozantinib for advanced RCC

  • Reply to

    xl-888

    by timesensitive Mar 29, 2016 7:12 PM
    wilderguide wilderguide Mar 29, 2016 7:31 PM Flag

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    Good find. This trial has been anticipated for some time, and MMM has spoken of it a time or two...
    Can't hurt to have a proven HSP90i in the pipeline...especially one with a triplet-driven 90% ORR.

  • Reply to

    Potential of Ipsen collaboration

    by wilderguide Mar 25, 2016 2:02 PM
    wilderguide wilderguide Mar 29, 2016 5:48 PM Flag

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    Trastuzumab, no.. It was used only as an example of a drug delivered via conjugated process...
    You'd need to follow the entirety of that thread with clemcaldwell to maintain context...

  • Reply to

    CS-3150 P3 trial initiated

    by wilderguide Mar 29, 2016 7:55 AM
    wilderguide wilderguide Mar 29, 2016 4:52 PM Flag

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    What's a mattah, Big Angry Short Kahuna?
    Big Mamasan no long to rikey ride yo psycho bikey???
    Orny one answerah, angry rittle shortfellwah...
    Grow a nut...

  • Reply to

    Potential of Ipsen collaboration

    by wilderguide Mar 25, 2016 2:02 PM
    wilderguide wilderguide Mar 29, 2016 4:24 PM Flag

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    Google: "T-DM1 mechanism of action"
    This is a good tutorial...
    Trastuzumab - bonded to a delivery molecule that - upon delivery to regional disease - is unlinked from the molecule to optimize cellular concentration of cytotoxic effect while the overall patient remains systemically under-exposed to toxicity. As the treatment concentration is unleashed, the cleaved bond between molecules dissolves the compound molecule...expelling the delivery molecule thru excretive process. Better exposure to diseased cells - lesser systemic exposure.

  • Reply to

    Potential of Ipsen collaboration

    by wilderguide Mar 25, 2016 2:02 PM
    wilderguide wilderguide Mar 29, 2016 3:20 PM Flag

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    "Wouldn't they have considered what you are talking about?"
    I wonder that too...
    EXEL doesn't possess the technology - but a lot of their partners have access. For discussion's sake...any partner with IMGN would have access to their ADC platform. Any partner with SNTA would have access to their HDC program. Establishing the treatment rationale is key to configuring toward future direction. My point is simply that alternatively less toxic delivery platforms have been extensively explored - why not Cabo? If you get it figured out before me, would'jya please post it? I'm dying to know how all this turns out? Good luck, Clem!

  • Reply to

    CS-3150 P3 trial initiated

    by wilderguide Mar 29, 2016 7:55 AM
    wilderguide wilderguide Mar 29, 2016 2:59 PM Flag

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    Additionally...
    It makes me consider that DS may be part of the large SI...
    They may have seen the potential longer than they have let on...
    Wouldn't you place a bet on a drug or two?

  • Reply to

    CS-3150 P3 trial initiated

    by wilderguide Mar 29, 2016 7:55 AM
    wilderguide wilderguide Mar 29, 2016 2:54 PM Flag

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    "...if nothing else..."
    My imagination won't let go of an international Ménage a Trois...
    DS, Ipsen, & EXEL...the Holy Trinity of global ccRCC 2nd line treatment.
    Put that in your pipe and smoke it...

  • Reply to

    CS-3150 P3 trial initiated

    by wilderguide Mar 29, 2016 7:55 AM
    wilderguide wilderguide Mar 29, 2016 2:41 PM Flag

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    "Not all that long for a long term study."
    I saw that, too. In addition, they'll have long term data from the preceding 800+ P2 trial patients, over a variety of subsets. Enough to file on? I think we have seen less...

  • Reply to

    CS-3150 P3 trial initiated

    by wilderguide Mar 29, 2016 7:55 AM
    wilderguide wilderguide Mar 29, 2016 1:49 PM Flag

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    Ahhhhhsooooo....
    U no rikey de prospeck ub good newsba, shorty wrongfellwa?
    May your Mamasan forever ridey some other Longfellwas bikey...

  • Reply to

    CS-3150 P3 trial initiated

    by wilderguide Mar 29, 2016 7:55 AM
    wilderguide wilderguide Mar 29, 2016 1:39 PM Flag

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    Joe...you've gone and done did it again...
    You've read my mind. I'd been watching the CS-3150 program closely for any hint of move into pivotal trial, data presentation...or a program dead in the water announcement. As a partner, DS makes sense. They are #2 in Japan - perhaps a coincidence that Ipsen is #2 in France? Doesn't #2 historically try harder?

  • Reply to

    CS-3150 P3 trial initiated

    by wilderguide Mar 29, 2016 7:55 AM
    wilderguide wilderguide Mar 29, 2016 1:06 PM Flag

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    I would consider a move into P3 to be a material event. I suspect the clock is ticking toward a PR, either from DS, EXEL - perhaps from both. Timely tell if I'm wrong, but I don't see any downside to the development of CS-3150. The 2006 filing states quite clearly that DS is responsible for all costs going toward commercialization. Marketing costs are not mentioned in the initial filing, though I wouldn't rule out a collaborative cost sharing. At this point, I see no downside to a PR...

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