Therapeutics/pharmacology

Poster

Cellular Biomeasures in Pre-clinical Development of a Monoclonal Antibody Against a Cytokine Receptor Implicated in Autoimmune Disorders

Friday, June 16
6:15 PM - 7:30 PM

Biomeasures form an important component of the pre-clinical pharmacodynamic markers to assess the functional competence of a biologic and for enabling theoretical modeling for dose projections. Here, we share our results with flow and mass cytometry based biomeasures and pharmacodynamic markers employed for human and cynomolgus monkey studies for the development of Antibodies A and B designed for treatment of autoimmune diseases. Antibody A and Antibody B are monoclonal antibodies against a cytokine receptor that is present on several different types of immune cells. In order to characterize the in vivo pharmacology and safety of our antibodies and to translate the results into a human setting, we first developed multi-parameter flow and marker mass cytometry panels for deep phenotyping human and cynomolgus immune cells and quantified the expression of the target cytokine receptor on single cells from the immune subsets identified above using Quantibrite™ PE based flow cytometry and mass cytometry. The highest expression was seen on pDC, memory fractions of CD4 and CD8 T cells and gamma delta T cells. Finally we show results from two in vivo cynomolgus monkey studies treated with either Antibody A or Antibody B where the antibodies efficiently depleted the cells expressing target cytokine receptor consistent with the level of expression of the receptor. In both studies, no in-life adverse events or significant safety concerns were observed. The results from these studies were used in the development of a theoretical model to predict the kinetics of cell depletion in cynomolgus monkeys.

Kondala Atkuri

Principal Scientist
Pfizer Inc.

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    Chad Stevens

    Scientist
    Pfizer Inc.

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      Abhinav Tiwari

      Manager, ClinPharm
      Pfizer Inc.

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        Martin Dowty

        Associate Research Fellow
        Pfizer Inc.

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          Kathleen Phillips

          Principal Scientist
          Pfizer Inc.

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            Cellular Biomeasures in Pre-clinical Development of a Monoclonal Antibody Against a Cytokine Receptor Implicated in Autoimmune Disorders



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