ReviewmAbs2018
Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment.
Review in mAbs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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.
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.
Who cites it
20 citing papers in PubMed, 65 citations in OpenAlex.
- The Association of Primate Veterinarians and the European Primate Veterinarians Position Statement on the Value of Nonhuman Primates in Research.Journal of the American Association for Laboratory Animal Science : JAALAS · 2026Article
- Trends of laboratory nonhuman primate licensing in China between 2020 and 2024: A national database analysis.PloS one · 2026Article
- From Genetic Engineering to Preclinical Safety: A Study on Recombinant Human Interferons.International journal of molecular sciences · 2025Article
- A humanized antibody against mucormycosis targets angioinvasion and augments the host immune response.Science translational medicine · 2025Article
- Harnessing cellular therapeutics for type 1 diabetes mellitus: progress, challenges, and the road ahead.Nature reviews. Endocrinology · 2025Review
- Immunogenicity risk assessment and mitigation for engineered antibody and protein therapeutics.Nature reviews. Drug discovery · 2024Review
- In vivo delivery of engineered synthetic DNA-encoded SARS-CoV-2 monoclonal antibodies for pre-exposure prophylaxis in non-human primates.Emerging microbes & infections · 2024Article
- Revolutionizing cancer treatment: comprehensive insights into immunotherapeutic strategies.Medical oncology (Northwood, London, England) · 2024Review
- Review of the Immune Checkpoint Inhibitors in the Context of Cancer Treatment.Journal of clinical medicine · 2023Review
- Amyloid-β targeting immunisation in aged non-human primate (Microcebus murinus).Brain, behavior, and immunity · 2023Article
- Monoclonal Antibodies for Bacterial Pathogens: Mechanisms of Action and Engineering Approaches for Enhanced Effector Functions.Biomedicines · 2022Review
- Justification for species selection for pharmaceutical toxicity studies.Toxicology research · 2020Article
- Targeting cardiac fibrosis in heart failure with preserved ejection fraction: mirage or miracle?EMBO molecular medicine · 2020Review
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- Strategies for Generating Diverse Antibody Repertoires Using Transgenic Animals Expressing Human Antibodies.Frontiers in immunology · 2018Article
- Article
- Exploring the Definition of "Similar Toxicities": Case Studies Illustrating Industry and Regulatory Interpretation of ICH S6(R1) for Long-Term Toxicity Studies in One or Two Species.International journal of toxicologyArticle
- Integration of Consortia Recommendations for Justification of Animal Use Within Current and Future Drug Development Paradigms.International journal of toxicologyArticle
- Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 7 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Monoclonal antibodies (mAbs) are improving the quality of life for patients suffering from serious diseases due to their high specificity for their target and low potential for off-target toxicity. The toxicity of mAbs is primarily driven by their pharmacological activity, and therefore safety testing of these drugs prior to clinical testing is performed in species in which the mAb binds and engages the target to a similar extent to that anticipated in humans. For highly human-specific mAbs, this testing often requires the use of non-human primates (NHPs) as relevant species. It has been argued that the value of these NHP studies is limited because most of the adverse events can be predicted from the knowledge of the target, data from transgenic rodents or target-deficient humans, and other sources. However, many of the mAbs currently in development target novel pathways and may comprise novel scaffolds with multi-functional domains; hence, the pharmacological effects and potential safety risks are less predictable. Here, we present a total of 18 case studies, including some of these novel mAbs, with the aim of interrogating the value of NHP safety studies in human risk assessment. These studies have identified mAb candidate molecules and pharmacological pathways with severe safety risks, leading to candidate or target program termination, as well as highlighting that some pathways with theoretical safety concerns are amenable to safe modulation by mAbs. NHP studies have also informed the rational design of safer drug candidates suitable for human testing and informed human clinical trial design (route, dose and regimen, patient inclusion and exclusion criteria and safety monitoring), further protecting the safety of clinical trial participants.
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Registered trials
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.