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MannKind Corp. Message Board

wildbiftek 12 posts  |  Last Activity: Jan 29, 2015 11:44 AM Member since: Oct 25, 2011
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  • Reply to

    METEOR

    by saltydog711 Jan 29, 2015 9:13 AM
    wildbiftek wildbiftek Jan 29, 2015 11:44 AM Flag

    Jump in the value of the Swiss Franc relative to other currencies. may mean Roche goes shopping.

  • wildbiftek wildbiftek Dec 29, 2014 11:57 PM Flag

    The reason the Tivozanib arm had worse overall OS is most likely due to the fact that the patients on the control Sorafenib arm were offered the chance to cross over to Tivozanib whereas the experimental Tivozanib arm was not. There are plenty of studies which suggest that doing a course of multiple TKIs in sequence will offer benefits over just a single type and it's likely this is what happened here.

    AVEO probably thought that because PFS was the agreed upon end point that the FDA would tolerate this. In the end, the equipoise of their trial design was called into question during an advisory panel, the drug was voted down, and the FDA took that recommendation.

  • Reply to

    Cabo DOES relieve pain

    by icprecipice Dec 2, 2014 10:32 AM
    wildbiftek wildbiftek Dec 3, 2014 8:26 AM Flag

    That's a fine point, and I believe the compound is active in mCRPC and does relieve pain / clear bone mets. What it doesn't change is that both trials in mCRPC failed under their intended design and there's a lot of debt to address before 2017. There is a lot less to like about this company now given its more precarious financial situation, but I'm sticking it out through RCC readout because I think Cobi's success is sufficient for the company's survival.

    I listened to yesterday's presentation but it side stepped the issue of COMET-1 and 2 as well as debt. It was more or less a scripted and uninteresting advertisement for the company's strictly positive prospects.

  • Reply to

    COMET-2 fails to meet end point

    by wildbiftek Dec 1, 2014 8:11 AM
    wildbiftek wildbiftek Dec 1, 2014 8:16 AM Flag

    I think in light of this result, there is really no hope for Cabo in prostate cancer.

  • Very dissappointing, I had thought this was more of a sure thing than COMET-1.

    "Exelixis, Inc. (NASDAQ: EXEL) today announced top-line results from the final analysis of COMET-2, a randomized, double-blind, controlled trial of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC) who are suffering from moderate to severe pain despite optimized narcotic medication, and whose disease has progressed following treatment with docetaxel as well as abiraterone and/or enzalutamide. The trial did not meet its primary endpoint of alleviation of bone pain, as determined by comparing the percentage of patients in the two treatment arms who achieved a pain response at Week 6 that was confirmed at Week 12 without increase in narcotic medication. Fifteen percent of patients in the cabozantinib arm reported a pain response, compared to 17 percent of patients in the control arm receiving mitoxantrone/ prednisone. The difference in pain response between the arms was not statistically significant. The safety profile of cabozantinib in the trial was consistent with that observed in previous studies in mCRPC."

  • Reply to

    78% Overall Response Rate

    by slumdawg2011 Nov 25, 2014 9:29 AM
    wildbiftek wildbiftek Nov 26, 2014 11:12 AM Flag

    Do you mean IMGN779? I thought the findings were in acute myeloid leukemia. Afaik the naked antibody SAR650984 is the only potentially ALL targeted (among others) molecule that IMGN has a hand in. Looks like a winner for sure I don't think the royalties are so good since it isn't an ADC.

  • Reply to

    Cabo with Immunotherapy

    by wildbiftek Nov 13, 2014 10:46 AM
    wildbiftek wildbiftek Nov 14, 2014 9:14 AM Flag

    I believe they said on the last CC that they'd be taking that option:

    "We also expect to exercise our option to extend the maturity date of the Deerfield notes from July 1, 2015 to July 1, 2018 as provided for by the January 2014 amendments to the note for disagreement with Deerfield. We have until March 31, 2015 to exercise this option."

    It is known. The question is more the unknown unknowns, namely RCC results and other moves that they might make to keep themselves going.

  • Reply to

    Cabo with Immunotherapy

    by wildbiftek Nov 13, 2014 10:46 AM
    wildbiftek wildbiftek Nov 13, 2014 10:48 AM Flag

    This is of purely academic interest, EXEL needs to overcome its debt hurdles and gain approval for RCC first for this to matter to shareholders.

  • wildbiftek by wildbiftek Nov 13, 2014 10:46 AM Flag

    "Dual effects of a targeted small-molecule inhibitor (cabozantinib) on immune-mediated killing of tumor cells and immune tumor microenvironment permissiveness when combined with a cancer vaccine

    BackgroundGrowing awareness of the complexity of carcinogenesis has made multimodal therapies for cancer increasingly compelling and relevant. In recent years, immunotherapy has gained acceptance as an active therapeutic approach to cancer treatment, even though cancer is widely considered an immunosuppressive disease. Combining immunotherapy with targeted agents that have immunomodulatory capabilities could significantly improve its efficacy.MethodsWe evaluated the ability of cabozantinib, a receptor tyrosine kinase inhibitor, to modulate the immune system in vivo as well as alter the phenotype of tumor cells in vitro in order to determine if this inhibitor could act synergistically with a cancer vaccine.ResultsOur studies indicated that cabozantinib altered the phenotype of MC38-CEA murine tumor cells, rendering them more sensitive to immune-mediated killing. Cabozantinib also altered the frequency of immune sub-populations in the periphery as well as in the tumor microenvironment, which generated a more permissive immune environment. When cabozantinib was combined with a poxviral-based cancer vaccine targeting a self-antigen, the combination significantly reduced the function of regulatory T cells and increased cytokine production from effector T cells in response to the antigen. These alterations to the immune landscape, along with direct modification of tumor cells, led to markedly improved antitumor efficacy.ConclusionsThese studies support the clinical combination of cabozantinib with immunotherapy for the treatment of cancer."

  • Reply to

    ODAC Votes 5-2 Against Panobinostat in Myeloma

    by wildbiftek Nov 7, 2014 2:15 PM
    wildbiftek wildbiftek Nov 7, 2014 2:57 PM Flag

    "The problem I see here, is that the therapy has a PFS benefit but there's nothing else to hang our hat on," Deborah Armstrong, MD, ODAC chairperson and an associate professor of oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, said during the meeting. "I think we struggle when we don't see an overall survival benefit."

    First I have no idea if there will even be a committee, but if there is, it might be a closer vote because they would have COMET-2 and the very last-line salvage status of patients to "hang their hats on." I'm not expecting approval though.

  • Reply to

    ODAC Votes 5-2 Against Panobinostat in Myeloma

    by wildbiftek Nov 7, 2014 2:15 PM
    wildbiftek wildbiftek Nov 7, 2014 2:16 PM Flag

    "PFS was not the question, there's clearly a benefit," Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said during the event. "The question is what is the magnitude of benefit and does it warrant the toxicity."

  • Onclive article.

    Similarity w/ Cabo:
    - Statsig PFS, no statsig OS benefit
    - High toxicity

    Difference:
    - Patients had only one prior line of therapy vs 2 or 3 in COMET-1.
    - COMET-2 results will also be available when considering Cabo in mCPRC.

    "First, this was a very difficult decision because I think this agent does have some activity in this disease and can be useful in this disease," James E. Liebmann, MD, ODAC panelist from the UMass Memorial Medical Center, said after casting a vote against the approval. "I think the toxicity outweighed the marginal benefit in progression-free survival. I hope that the drug is not given up on."

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