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Celldex Therapeutics, Inc. Message Board

  • soros_sr soros_sr Oct 1, 2013 8:26 AM Flag

    Celldex: CDX-1127 (Solid Tumors) Phase I Data by YE13 May Show Clinical Benefit Rate in High Teens

    Celldex: CDX-1127 (Solid Tumors) Phase I Data by YE13 May Show Clinical Benefit Rate in High Teens

    The phase I data from Celldex' CDX-1127 is highly anticipated especially since some have linked the
    potential of CDX-1127 to other immune modulating therapies such as anti-CTLA-4 (Yervoy) and PD-1.
    Phase I open label dose escalation study (3+3 design) will include 170 patients with solid
    tumors/hematological malignancies. The study will enroll patients having leukemia/lymphomas,
    melanoma, renal cell, ovarian, non-small cell lung, colorectal or prostate cancers. Patients will initially
    receive a single dose of CDX 1127, followed by a 28-day observation period and a multi-dose phase (1
    cycle of 4 weekly doses of CDX- 1127). We expect preliminary data from the solid tumor subgroup
    (dose-esc/partial dose-expansion) at Society of Immunotherapy of Cancer (Nov 6-10) and lymphoma
    subgroup (dose-esc cohort) at ASCO 2014.
    One drawback of CDX-1127 phase I trial is that there is no selection of patients based on the CD27
    expression, unlike SGN-75 and SGN-40 phase I programs. Therefore, we believe that stratifying the
    patient population based on CD27 expression could be a probable scenario in the phase II program.
    We believe that CDX-1127 will have a good safety profile and based on the analysis of proxy antibodies
    such as SeattleGenetics' SGN-75/SGN-40, and Bristol's Yervoy. We also believe CDX-1127 could show
    a minimum of high teens SD or better, and could lead to potentially ›PRs in some patients over the
    duration of dose expansion cohort. Additionally, we believe that CDX-1127 could have an optimal
    response in melanoma, NHL and RCC based on our analysis of the SGN-75, SGN-40, and Yervoy
    programs.

    (continued - search on yahoo for title, it is a PDF)

    Sentiment: Strong Buy

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