Cross-Reactive Polyclonal Antibodies Raised Against GalNAc-Conjugated siRNA Recognize Mostly the GalNAc Moiety

Patisiran, an RNAi Therapeutic, for Hereditary Transthyretin Amyloidosis

Adams, D., Gonzalez-Duarte, A., O’Riordan, W. D., Yang, C.-C., Ueda, M., Kristen, A. V., Tournev, I., Schmidt, H. H., Coelho, T., Berk, J. L., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1716153 · Cited by 3,047 · see citing works

Advances in oligonucleotide drug delivery

Roberts, T. C., Langer, R., & Wood, M. J. A. (2020) · Nature Reviews Drug Discovery · doi:10.1038/s41573-020-0075-7 · Cited by 2,026 · see citing works

Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol

Ray, K. K., Wright, R. S., Kallend, D., Koenig, W., Leiter, L. A., Raal, F. J., Bisch, J. A., Richardson, T., Jaros, M., Wijngaard, P. L. J., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1912387 · Cited by 1,665 · see citing works

Therapeutic siRNA: state of the art

Hu, B., Zhong, L., Weng, Y., Peng, L., Huang, Y., Zhao, Y., & Liang, X.-J. (2020) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-020-0207-x · Cited by 1,586 · see citing works

The current state and future directions of RNAi-based therapeutics

Setten, R. L., Rossi, J. J., & Han, S.-P. (2019) · Nature Reviews Drug Discovery · doi:10.1038/s41573-019-0017-4 · Cited by 1,443 · see citing works

GalNAc-siRNA conjugates: leading the way for delivery of RNAi therapeutics

Springer, A. D., & Dowdy, S. F. (2018) · Nucleic Acid Therapeutics · doi:10.1089/nat.2018.0736 · Cited by 711 · see citing works

Phase 3 Trial of RNAi Therapeutic Givosiran for Acute Intermittent Porphyria

Balwani, M., Sardh, E., Ventura, P., Peiró, P. A., Rees, D. C., Stölzel, U., Bissell, D. M., Bonkovsky, H. L., Windyga, J., Anderson, K. E., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1913147 · Cited by 608 · see citing works

Lumasiran, an RNAi Therapeutic for Primary Hyperoxaluria Type 1

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Efficacy and safety of vutrisiran for patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy: a randomized clinical trial

Adams, D., Tournev, I., Taylor, M., Coelho, T., Planté‐Bordeneuve, V., Berk, J. L., González‐Duarte, A., Gillmore, J. D., Low, S.-C., Sekijima, Y., et al. (2022) · Amyloid · doi:10.1080/13506129.2022.2091985 · Cited by 409 · see citing works

Preclinical and Clinical Advances of GalNAc-Decorated Nucleic Acid Therapeutics

Huang, Y. (2016) · Molecular Therapy — Nucleic Acids · doi:10.1016/j.omtn.2016.12.003 · Cited by 295 · see citing works

Randomized, Placebo-Controlled Trial of Mipomersen in Patients with Severe Hypercholesterolemia Receiving Maximally Tolerated Lipid-Lowering Therapy

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Comparing ELISA and Surface Plasmon Resonance for Assessing Clinical Immunogenicity of Panitumumab

Lofgren, J. A., Dhandapani, S., Pennucci, J. J., Abbott, C. M., Mytych, D. T., Kaliyaperumal, A., Swanson, S. J., & Mullenix, M. C. (2007) · The Journal of Immunology · doi:10.4049/jimmunol.178.11.7467 · Cited by 197 · see citing works

An Affinity Capture Elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug

Bourdage, J. S., Cook, C. A., Farrington, D. L., Chain, J. S., & Konrad, R. J. (2007) · Journal of Immunological Methods · doi:10.1016/j.jim.2007.07.004 · Cited by 157 · see citing works

Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility

Wadhwa, M., Knežević, I., Kang, H., & Thorpe, R. (2015) · Biologicals · doi:10.1016/j.biologicals.2015.06.004 · Cited by 147 · see citing works

Pharmacokinetics and Pharmacodynamics of the Small Interfering Ribonucleic Acid, Givosiran, in Patients With Acute Hepatic Porphyria

Agarwal, S., Simon, A. R., Goel, V., Habtemariam, B. A., Clausen, V. A., Kim, J. B., & Robbie, G. J. (2020) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.1802 · Cited by 104 · see citing works

Anti-drug Antibody Validation Testing and Reporting Harmonization

Myler, H. A., Pedras-Vasconcelos, J., Phillips, K. R., Hottenstein, C. S., Chamberlain, P., Devanaryan, V., Gleason, C. R., Goodman, J., Manning, M. S., Purushothama, S., et al. (2021) · The AAPS Journal · doi:10.1208/s12248-021-00649-y · Cited by 86 · see citing works

Detection of low-affinity anti-drug antibodies and improved drug tolerance in immunogenicity testing by Octet® biolayer interferometry

Li, J., Schantz, A., Schwegler, M., & Shankar, G. (2010) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2010.08.022 · Cited by 83 · see citing works

Effect of inclisiran, the small-interfering RNA against proprotein convertase subtilisin/kexin type 9, on platelets, immune cells, and immunological biomarkers: a pre-specified analysis from ORION-1

Landmesser, U., Haghikia, A., Leiter, L. A., Wright, R. S., Kallend, D., Wijngaard, P., Stoekenbroek, R., Kastelein, J. J., & Ray, K. K. (2021) · Cardiovascular Research · doi:10.1093/cvr/cvaa077 · Cited by 83 · see citing works

Activation of Innate Immunity by Therapeutic Nucleic Acids

Bishani, A., & Chernolovskaya, E. L. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms222413360 · Cited by 34 · see citing works

Immunogenicity Assessment of Inotersen, a 2′- O -(2-Methoxyethyl) Antisense Oligonucleotide in Animals and Humans: Effect on Pharmacokinetics, Pharmacodynamics, and Safety

Yu, R. Z., Wang, Y., Norris, D., Kim, T., Narayanan, P. K., Geary, R. S., Monia, B. P., & Henry, S. P. (2020) · Nucleic Acid Therapeutics · doi:10.1089/nat.2020.0867 · Cited by 29 · see citing works

Assessment of the Immunogenicity Potential for Oligonucleotide-Based Drugs

Henry, S. P., Arfvidsson, C., Arrington, J., Canadi, J., CROWE, D. F., Gupta, S., Lohmann, S., Massonnet, B., Mytych, D. T., Rogers, T., et al. (2022) · Nucleic Acid Therapeutics · doi:10.1089/nat.2021.0112 · Cited by 24 · see citing works

Considerations in the Immunogenicity Assessment Strategy for Oligonucleotide Therapeutics (ONTs)

Bano, N., Ehlinger, C., Yang, T., Swanson, M., & Allen, S. (2022) · The AAPS Journal · doi:10.1208/s12248-022-00741-x · Cited by 23 · see citing works

Development and validation of a novel immunogenicity assay to detect anti-drug and anti-PEG antibodies simultaneously with high sensitivity

Bivi, N., Swearingen, C., Shockley, T. E., Sloan, J. H., Pottanat, T. G., Carter, Q. L., Hodsdon, M. E., Siegel, R. W., & Konrad, R. J. (2020) · Journal of Immunological Methods · doi:10.1016/j.jim.2020.112856 · Cited by 13 · see citing works

A sensitive and drug tolerant assay for detecting anti-AAV9 antibodies using affinity capture elution

Simmons, E. M., Wen, Y., Li, J., Qian, Y., Wong, L. C., Konrad, R. J., & Bivi, N. (2022) · Journal of Immunological Methods · doi:10.1016/j.jim.2022.113397 · Cited by 11 · see citing works

A competitive ligand binding assay for detection of neutralizing antibodies against an insulin analog

Peek, V. L., Lemen, D., Konrad, R. J., & Wen, Y. (2023) · Journal of Immunological Methods · doi:10.1016/j.jim.2023.113575 · Cited by 9 · see citing works

Inclisiran SiRNA therapy for durable LDL-C reduction: a systematic review and meta-analysis highlighting a breakthrough in long-term cardiovascular risk management

Satyam, S. M., El-Tanani, M., Patni, M. A., Rehman, A., Irshad, S. M., Raheem, R., Junais, E., John, A. A., Rassal, R. Y., Kumari, R., et al. (2026) · BMC Cardiovascular Disorders · doi:10.1186/s12872-026-05515-3 · Cited by 5 · see citing works

Consideration for immunogenicity assay development for oligonucleotide therapeutics

Jou, A. F., & Hainline, K. M. (2026) · Bioanalysis · doi:10.1080/17576180.2026.2695220 · Cited by 1 · see citing works

Affinity Capture Elution Coupled with Cell-based Cyclic Adenosine Monophosphate Assay as a Platform Method for Detection of Neutralizing Antibodies to Incretin Molecules

Reynolds, N. A., Chen, Y., Higgs, R. E., Calderón, B., Cramer, J. W., Bivi, N., Hodsdon, M. E., Bullock, H. A., Shockley, T. E., Peek, V. L., et al. (2025) · The AAPS Journal · doi:10.1208/s12248-025-01143-5

Immunogenicity Assessment for siRNA Therapeutics: A Risk-Based Proposal for Event-Driven Testing

Zhao, A., Bond, S., Clausen, V. A., Chen, M., Lai, C., Zylstra, J., Grimaldi, C., & Partridge, M. A. K. (2026) · The AAPS Journal · doi:10.1208/s12248-026-01260-9

Immunogenicity Assessment for siRNA Therapeutics: A Risk-Based Proposal for Event-Driven Testing

Zhao, A., Bond, S., Clausen, V. A., Chen, M., Lai, C., Zylstra, J., Grimaldi, C., & Partridge, M. A. K. (2026) · The AAPS Journal · doi:10.1208/s12248-026-01260-9

The Nonclinical Safety Profile of GalNAc-conjugated RNAi Therapeutics in Subacute Studies

Janas, M. M., Harbison, C. E., Perry, V. K., Carito, B. A., Sutherland, J. E., Vaishnaw, A. K., Keirstead, N. D., & Warner, G. L. (2018) · Toxicologic Pathology · doi:10.1177/0192623318792537 · Cited by 82 · see citing works

Overcoming the Innate Immune Response to Small Interfering RNA

Judge, A. D., & MacLachlan, I. (2008) · Human Gene Therapy · doi:10.1089/hum.2007.179 · Cited by 279 · see citing works

The therapeutic prospects of N-acetylgalactosamine-siRNA conjugates

Zhang, L., Liang, Y., Liang, G., Tian, Z., Zhang, Y., Liu, Z., & Ji, X. (2022) · Frontiers in Pharmacology · doi:10.3389/fphar.2022.1090237 · Cited by 50 · see citing works

siRNA and isRNA: two edges of one sword

Schlee, M., Hornung, V., & Hartmann, G. (2006) · Molecular Therapy · doi:10.1016/j.ymthe.2006.06.001 · Cited by 215 · see citing works