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2000
Volume 21, Issue 6
  • ISSN: 1573-4110
  • E-ISSN: 1875-6727

Abstract

Background

PYX-106 is a fully human monoclonal antibody (mAb), targeting sialic acid binding immunoglobulin-like lectin-15 (Siglec-15), an immunosuppressive agent with widespread expression across various tumor types.

Methods

To facilitate the evaluation of immunogenicity for PYX-106 in human serum, a validated method was established to enable the detection (screening, confirmatory, and titration) of antibodies to PYX-106 in human serum samples.

Results

The Screening Cut-Point Factor (SCPF), Confirmatory Cut-Point (CCP), and Titration Cut-Point Factor (TCPF) were found to be 1.51, 26.9%, and 1.86, respectively. Sensitivity was determined to be 1.81 ng/mL in the screening assay and 1.25 ng/mL in the confirmatory assay. Low Positive Control (LPC) was set at 6.00 ng/mL, and High Positive Control (HPC) was set at 1000 ng/mL. The drug tolerance was up to 500 µg/mL at the HPC level, up to 241 µg/mL at the ADA 100 ng/mL level, and up to 38.9 µg/mL at the LPC level. The intra-assay percent coefficient of variation (%CV) was ≤ 2.1% for Positive Controls (PCs) in the screening assay and ≤ 1.0% for PCs in the confirmatory assay. The inter-assay %CV was ≤ 15.3% for PCs in the screening assay and ≤ 2.1% for PCs in the confirmatory assay. No hook effect, hemolysis effect, lipemia effect, or bilirubin interference was found in this ADA method. Anti-PYX-106 antibodies were found stable in human serum for at least 23 hours 51 minutes at room temperature or after six freeze/thaw cycles.

Conclusion

Anti-PYX-106 ADA bioanalytical assay validation was reported for the first time in any biological matrix. This ADA method has been successfully applied to human sample analysis to support a clinical study.

© 2025 Bentham Science Publishers
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/content/journals/cac/10.2174/0115734110295203240903045117
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A Novel Electrochemiluminescence (ECL) Immunoassay for Detection of Anti-drug Antibodies (ADAs) to a Monoclonal Antibody (mAb) PYX-106 in Human Serum
Current Analytical Chemistry 21, 702 (2025); https://doi.org/10.2174/0115734110295203240903045117
/content/journals/cac/10.2174/0115734110295203240903045117
/content/journals/cac/10.2174/0115734110295203240903045117
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  • Article Type:     Research Article
Keyword(s): ADA; ECL; immunogenicity; mAb; MSD; oncology; PYX-106; siglec-15; validation

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