Evidence map›Paper›PMID 38570436›Full record

ArticleThe AAPS journal2024

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

Kimberly K Ballman, Victoria L Peek, John H Sloan, Jingling Li, Robert J Konrad, Yi Wen

Abstract read
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In one paragraph

Article in The AAPS journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Kimberly K BallmanLilly Research Laboratories, Eli Lilly and Company, Indianapolis, 46285, Indiana, USA.
Victoria L PeekLilly Research Laboratories, Eli Lilly and Company, Indianapolis, 46285, Indiana, USA.
John H SloanLilly Research Laboratories, Eli Lilly and Company, Indianapolis, 46285, Indiana, USA.
Jingling LiLilly Research Laboratories, Eli Lilly and Company, Indianapolis, 46285, Indiana, USA.
Robert J KonradLilly Research Laboratories, Eli Lilly and Company, Indianapolis, 46285, Indiana, USA.
Yi WenLilly Research Laboratories, Eli Lilly and Company, Indianapolis, 46285, Indiana, USA. wen_yi1@lilly.com.ORCID http://orcid.org/0000-0003-4862-6427

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Small interfering RNA (siRNA) is gaining momentum as a therapeutic modality with six approved products. Since siRNA has the potential to elicit undesired immune responses in patients, immunogenicity assessment is required during clinical development by regulatory authorities. In this study, anti-siRNA polyclonal antibodies were generated through animal immunization. These cross-reactive polyclonal antibodies recognized mostly the N-acetylgalactosamine (GalNAc) moiety with a small fraction against sequence-independent epitopes. We demonstrate that the polyclonal antibodies can be utilized as immunogenicity assay positive controls for the same class of GalNAc-conjugated siRNAs. In addition, anti-GalNAc mAbs showed desired sensitivity and drug tolerance, supporting their use as alternative surrogate positive controls. These findings can guide positive control selection and immunogenicity assay development for GalNAc-conjugated siRNAs and other oligonucleotide therapeutics.

Indexed as

AcetylgalactosamineOligonucleotidesAnimalsAntibodies, MonoclonalHumansRNA, Small InterferingAcetylgalactosamineAntibodies, MonoclonalOligonucleotidesRNA, Small Interferingassay developmentGalNAcimmunogenicitypositive controlsiRNA

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.