Immunogenicity considerations for antibody–drug conjugates: a focus on neutralizing antibody assays
References
- 1 . Paul Ehrlich's magic bullets. N. Engl. J. Med. 350, 1079–1080 (2004).
- 2 . Antibody–drug conjugates in cancer therapy. Annu. Rev. Med. 64, 15–29 (2013).
- 3 . Drug-conjugated antibodies for the treatment of cancer. Br. J. Clin. Pharmacol. 76(2), 248–262 (2013).
- 4 . Trastuzumab emtansine: mechanisms of action and drug resistance. Breast Cancer Res. 16(2), 209 (2014).
- 5 Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N. Engl. J. Med. 346(7), 469–475 (2002).
- 6 US FDA. Guidance for Industry. Immunogenicity Assessment for Therapeutic Protein Products. Washington, DC, USA (2014). www.fda.gov/downloads/drugs/guidances/ucm338856.pdf.
- 7 US FDA. Draft Guideline. Guidance for Industry. Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Product. Washington, DC, USA (2016). www.fda.gov/downloads/Drugs/Guidances/UCM192750.pdf.
- 8 Committee for Medicinal Products for Human Use. Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins. European Medicines Agency, London, UK (2015). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/10/WC500194507.pdf.
- 9 Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J. Immunol. Methods 333(1–2), 1–9 (2008).
- 10 . A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs. Nat. Biotechnol. 25, 555–561 (2007).
- 11 . Therapeutic outcomes, assessments, risk factors and mitigation efforts of immunogenicity of therapeutic protein products. Cell. Immunol. 295, 118–126 (2015).
- 12 . Selection of reaction additives used in the preparation of monomeric antibody-calicheamicin conjugates. Bioconjug. Chem. 19(1), 358–361 (2008).
- 13 . New developments for antibody-drug conjugate-based therapeutic approaches. Curr. Opin. Immunol. 40, 14–23 (2016).
- 14 . Proposed mechanism of off-target toxicity for antibody–drug conjugates driven by mannose receptor uptake. Cancer Immunol. Immunother. 62(2), 217–223 (2013).
- 15 . T-cell dependent immunogenicity of protein therapeutics: preclinical assessment and mitigation. Clin. Immunol. 149(3), 534–555 (2013).
- 16 . Immunogenicity of antibody drug conjugates: bioanalytical methods and monitoring strategy for a novel therapeutic modality. AAPS J. 17(1), 35–43 (2015).
- 17 . Insights on the immunogenicity of antibody–drug conjugates. Bioanalysis 7(13), 1565–1568 (2015).
- 18 Kadcyla (ado-trastuzumab emtansine) [prescribing information]. Genentech Inc., CA, USA (2016). www.gene.com/download/pdf/kadcyla_prescribing.pdf.
- 19 Adcetris (brentuximab vedotin) [prescribing information]. Seattle Genetics, Inc., WA, USA (2016). www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf.
- 20 Center for Drug Evaluation and Research. Clinical pharmacology and biopharmaceutics review: Adcetris. Office of Clinical Pharmacology, MD, USA (2011). www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125388Orig1s000ClinPharmR.pdf.
- 21 Wyeth-Ayerst. Gemtuzumab ozogamicin, summary for presentation to the FDA's Oncologic Division Advisory Committee (2000). www.fda.gov/ohrms/dockets/ac/00/backgrd/3592b2c.pdf.
- 22 Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J. Pharm. Biomed. Anal. 48(5), 1267–1281 (2008).
- 23 Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Methods 289, 1–16 (2004).
- 24 . Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics. J. Immunol. Methods 408, 1–12 (2014).
- 25 Immunogenicity testing strategy and bioanalytical assays for antibody–drug conjugates. Bioanalysis 5(9), 1041–1055 (2013).
- 26 Recommendations for the validation of cell based assays used for detection of neutralizing antibody responses elicited to biological therapeutics. J. Pharm. Biomed. Anal. 55(5), 878–888 (2011).
- 27 Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J. Immunol. Methods 321, 1–18 (2007).
- 28 Comparison of competitive ligand-binding assay and bioassay formats for the measurement of neutralizing antibodies to protein therapeutics. J. Pharm. Biomed. Anal. 54(2), 251–358 (2011).
- 29 . Microtubule-binding agents: a dynamic field of cancer therapeutics. Nat. Rev. Drug Discov. 9(10), 790–803 (2010).
- 30 . Antibody drug conjugates for cancer therapy. Pharmacol. Rev. 68, 3–19 (2016).
- 31 Macrophages contribute to the antitumor activity of the anti-CD30 antibody SGN-30. Blood 110(13), 4370–4372 (2007).
- 32 . Trastuzumab-DM1 (T-DM1) retains all the mechanisms of action of trastuzumab and efficiently inhibits growth of lapatinib insensitive breast cancer. Breast Cancer Res. Treat. 128(2), 347–356 (2011).
- 33 Committee for Medicinal Products for Human Use. Guideline on Immunogenicity Assessment of Monoclonal Antibodies Intended for In vivo Clinical Use. European Medicines Agency, London, UK (2012). www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128688.pdf.
- 34 . Development and validation of cell-based assays for the detection of neutralizing antibodies to drug products: a practical approach. Bioanalysis 4(24), 2959–2970 (2012).
- 35 Strategies to determine assay format for the assessment of neutralizing antibody responses to biotherapeutics. AAPS J. 18(6), 1335–1350 (2016).
- 36 Development and characterization of a neutralizing anti-idiotype antibody against Mirvetuximab for Analysis of Clinical Samples. AAPS J. 19(4), 1223–1234 (2017).
- 37 . Cell-based assays for profiling activity and safety properties of cancer drugs. J. Parmacol. Toxicol. Meth. 54, 313–319 (2006).
- 38 Addressing drug effects on cut point determination for an anti-drug antibody assay. J. Immunol. Methods 284(1–2), 152–156 (2012).
- 39 Development and validation of a cell based assay for the detection of neutralizing antibodies against recombinant insulins. J. Immunol. Methods 1759(17), 30153–30159 (2017).
- 40 Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteins. J. Pharm. Biomed. Anal. 49(2), 311–318 (2009).
- 41 . Implementation of design of experiments (DOE) in the development and validation of a cell-based bioassay for the detection of anti-drug neutralizing antibodies in human serum. J. Immunol. Methods 376(1–2), 32–45 (2012).
- 42 Pre-existing antibody: biotherapeutic modality-based review. AAPS J. 18(2), 311–330 (2016).
- 43 Ligand binding assays in the 21st century laboratory: recommendations for characterization and supply of critical reagents. AAPS J. 14(2), 316–328 (2012).
- 44 . Characterization of critical reagents in ligand-binding assays: enabling robust bioanalytical methods and lifecycle management. Bioanalysis 5(2), 227–244 (2013).