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Transpl Int. 2019 Sep 15. doi: 10.1111/tri.13524. [Epub ahead of print]

Safety and pharmacodynamics of anti-CD2 monoclonal antibody treatment in cynomolgus macaques- an experimental study.

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Columbia Center for Translational Immunology, Department of Medicine, Columbia University Medical Center, New York, USA.
Division of Transplantation Surgery, CLINTEC, Karolinska Institute, and Department of Transplantation Surgery, Karolinska University Hospital, Stockholm, Sweden.
Department of Immunology, Genetics and Pathology, Section of Clinical Immunology, Uppsala University, Uppsala, Sweden.
MassBiologics, University of Massachusetts Medical School, Boston, MA, USA.
Department of Surgery, Columbia University Medical Center, New York, NY, USA.
Department of Microbiology and Immunology, Columbia University Medical Center, New York, NY, USA.



Anti-CD2 treatment provides targeted immunomodulatory properties that have demonstrated clinical usefulness to condition the immune system and to treat transplant rejection. The treatment is species-specific due to structural CD2 antigen differences between non-human primates and humans. Herein, we report the safety profile and efficacy of two modifications of the same anti-CD2 monoclonal antibody in cynomolgus macaques.


Twelve subjects received one i.v. anti-CD2 (of rat or rhesus type) dose each, range 1-4 mg/kg, and were followed for 1-7 days. Treatment effects were evaluated with flow cytometry on peripheral blood and histopathological evaluation of secondary lymphoid organs. In vitro inhibitory activity on primary MHC disparate MLRs was determined.


Upon anti-CD2 treatment, CD4+ , CD8+ memory subsets were substantially depleted. Naïve T-cells and Tregs were relatively spared, and exhibited lower CD2 expression than memory T-cells. Early immune reconstitution was noted for naïve cells, while memory counts had not recovered after one week. Both antibodies displayed a concentration-dependent MLR inhibition. Lymph node examination revealed no significant lymphocyte depletion. None of the animals experienced any significant study drug-related adverse events.


This study outlines the safety and pharmacodynamic profile of primate-specific anti-CD2 treatment, relevant for translation of anti-CD2-based animal models into clinical trials.


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