preexisting antibodies to an f(ab′)2 antibody therapeutic and novel method for immunogenicity assessment

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ID: 129361
2016
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Abstract
Anti-therapeutic antibodies (ATAs) may impact drug exposure and activity and induce immune complex mediated toxicity; therefore the accurate measurement of ATA is important for the analysis of drug safety and efficacy. Preexisting ATAs to the hinge region of anti-Delta like ligand 4 (anti-DLL4) F(ab′)2, a potential antitumor therapeutic, were detected in cynomolgus monkey serum, which presented a challenge in developing assays for detecting treatment induced ATA. A total ATA assay was developed using a bridging ELISA that detected both anti-CDR and anti-framework ATA including anti-hinge reactivity. A competition assay that could detect 500 ng/mL of anti-CDR ATA in the presence of preexisting ATA was also developed to determine ATA specific to the anti-DLL4 F(ab′)2 CDR using anti-DLL4 F(ab′)2 and a control F(ab′)2. We used these assay methods in a cynomolgus monkey in vivo study to successfully evaluate total and anti-CDR ATA. The preexisting anti-hinge reactivity was also observed to a lesser extent in human serum, and a similar approach could be applied for specific immunogenicity assessment in clinical trials.
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ruppel2016journalpreexisting Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors ;Jane Ruppel;Ann Brady;Rebecca Elliott;Cecilia Leddy;Marco Palencia;Daniel Coleman;Jessica A. Couch;Eric Wakshull
Journal journal of photochemistry and photobiology b, biology
Year 2016
DOI
10.1155/2016/2921758
URL
http://dx.doi.org/10.1155/2016/2921758
Keywords
immunologic diseases allergy

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