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  • 1.  PK and IMG assessments of co-meds

    Posted 09-23-2024 10:09

    Hi Community,

    Can someone please remind me if there is any guidance regarding PK and immunogenicity assessment of co-meds? I have seen may examples of small molecules co-dosed with the biotherapeutic in development and no assessment being done for the small molecule. I have seen, however, the assessment performed for a co-dosed biologic, let's call it "A", with the biotherapeutic in development, "B". Of course, all assessments are needed for "B". I understand the reasons why the information would be nice to have, confirm through levels of "A"; confirm that "B" does not impact the immunogenicity of "A". I am interested in knowing if it is required or is it acceptable to collect and bank and NOT analyze, the immunogenicity samples of "A" unless there is impact on through levels of "A".  Does anyone think of a scenario where we don't need through levels of "A"?



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    Johanna Mora Ph.D.
    Bristol-Myers Squibb
    Princeton NJ
    [email protected]
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  • 2.  RE: PK and IMG assessments of co-meds

    Community Leadership
    Posted 09-23-2024 12:40

    For drugs that are intended to be sold together as a combination therapy, I do testing for both drugs since both are part of the test article. When an add-on to separate therapy or standard of care (SoC), particularly with an already approved biologic, I generally see samples banked for potential investigation. The likelihood of testing was higher for when both drugs manufactured by my employer, but not 100%, mainly because we already had the assays. Honestly, ADA for the second one unlikely unless generally a higher incidence or the new drug expected to make the immune system more reactive and there is a known impact of immunogenicity on the first drug. But a word of caution that you cannot compare to the other PK or IMG data for that second biologic unless you have either the same assay or a cross-validation. So it can only be used for comparison within your data set, not the label.

     

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    Joleen White Ph.D. (she/her)
    AAPS 2024 Global Health Community Chair
    Senior Bioassay Development Lead
    Gates Medical Research Institute
    Cambridge MA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 3.  RE: PK and IMG assessments of co-meds

    Posted 09-23-2024 12:54

    Thanks Joleen! I also see different scenarios requiring different approaches. In a recent case, the question was for SoC from another company, combined with one of ours in development. I agree, that if the drug in development has a MoA that is expected to activate the immune system. I would pre-emptively analyze.

     

    Johanna Mora, Ph.D. Scientific Senior Director

    Clinical Pharmacology, Pharmacometrics & Bioanalysis (CPPB)

    Route 206 & Province Line Road, Princeton, NJ 08543

     

    Bristol Myers Squibb

     

    "Gratitude can transform common days into thanksgivings, turn routine jobs into joy, and change ordinary opportunities into blessings." – William Arthur Ward

    "the person who disagrees with you is not necessarily disagreeing with your existence" -Adam Grant

     

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    Original Message