Advantages and Limitations of Commonly Used Nonhuman Primate Species in Research and Development of Biopharmaceuticals

Cauvin, Annick; Peters, Christopher M.; Brennan, Frank R.

doi:10.1016/b978-0-12-417144-2.00019-6

Cited by 39 publications

(34 citation statements)

References 53 publications

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“…Long-tailed macaques are Old World Monkeys, widely used as non-human primate models for biomedical research (Cauvin et al 2015). Their inability to display species-specific behaviours can cause the development of a general stress condition, abnormal behaviour, depression, and aggressive behaviours (Mallapur et al 2005).…”

Section: Discussionmentioning

confidence: 99%

Evaluation of an enrichment programme for a colony of long-tailed macaques (Macaca fascicularis) in a rescue centre

Albanese¹,

Kuan²,

Accorsi

et al. 2021

Primates

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Long-tailed macaques are highly social primates that are commonly used in biomedical research as animal models. The aim of this study was to evaluate the effects of different kinds of enrichment on the behaviour and faecal cortisol metabolite (FCM) level in a colony of ex-laboratory long-tailed macaques during a programme of rehabilitation. The research was carried out in three periods, divided into two sessions each. Every period was composed of one control session (SC) and one session characterised by one type of enrichment: feeding enrichment (FE), manipulative enrichment (ME), and the last session during which manipulative and feeding enrichment were provided every day but in a mixed way (MIX). The results showed that manipulative and mixed enrichments caused positive changes to the activity budget of the colony, with a decrease in abnormal behaviour rates and an increase in play compared with control sessions. The rate of affiliative behaviours and low rate of aggression were probably because the group was composed mostly of females and it was stable, with a well-defined hierarchy. The research underlines the importance of a well-studied enrichment programme for the welfare of captive animals, which should exploit species-specific motivations.

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Section: Discussionmentioning

confidence: 99%

Evaluation of an enrichment programme for a colony of long-tailed macaques (Macaca fascicularis) in a rescue centre

Albanese¹,

Kuan²,

Accorsi

et al. 2021

Primates

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“…It is also easy to handle rhesus monkeys, and therefore, they have been widely used in biomedical research. Cynomolgus monkeys bred exclusively for laboratory use are the most commonly used NHP models in pre-clinical trials these days, despite the unavailability of extensive genomic data for this species, unlike Rhesus monkeys 40 .…”

Section: Discussionmentioning

confidence: 99%

Comparison of the immunogenicity & protective efficacy of various SARS-CoV-2 vaccine candidates in non-human primates

Mukhopadhyay

Yadav

Gupta

et al. 2021

Indian Journal of Medical Research

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Background & objectives: The COVID-19 pandemic has emerged as a global public health crisis and research groups worldwide are engaged in developing vaccine candidates to curb its transmission, with a few vaccines having progressed to advanced stages of clinical trials. The aim of this systematic review was to compare immunogenicity and protective efficacy of various SARS-CoV-2 vaccine candidates tested in non-human primate (NHP) models. Methods: Literature on effect of SARS-CoV-2 vaccines in NHP models reported on PubMed and preprint platforms (medRxiv and bioRxiv) till October 22, 2020, was searched with the following terms: coronavirus vaccine, COVID-19 vaccine, SARS-CoV-2 vaccine, nonhuman primate, and rhesus macaque. Results: Our search yielded 19 studies, which reported immune response elicited by 18 vaccine candidates in NHP. All the vaccines induced detectable neutralizing antibody (NAb) titres in the serum of vaccinated animals, with some showing effective viral clearance from various organs. The vaccinated animals also showed nil to mild histopathological changes in their lungs compared to placebo groups in the trials that performed necropsy. Interpretation & conclusions: Our findings highlighted onset of quick immunogenicity and protective efficacy of mRNA-1273, followed by Ad26.CoV2.S, NVX-CoV2373, BNT162b2, RBD and BBV152 vaccine candidates in preclinical trials as compared to the others. NHP data also showed correlation with clinical trial data available for a few vaccines. Preclinical trials of COVID-19 vaccine candidates in NHPs yielded promising results, with some candidates faring better than others.

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“…BIO-5, an IgG4 mAb directed against a cytokine, is in development for inflammatory diseases. 50 The cynomolgus monkey was the only pharmacologically relevant species for safety assessment, based on in vitro potency on downstream signaling comparable to human, in vivo efficacy in a disease model and literature about similar distribution and function of the target. By contrast, no activity of BIO-5 could be demonstrated in rodents.…”

Section: Bio-5mentioning

confidence: 99%

Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment

Brennan

Cavagnaro

McKeever

et al. 2017

mAbs

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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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Advantages and Limitations of Commonly Used Nonhuman Primate Species in Research and Development of Biopharmaceuticals

Cited by 39 publications

References 53 publications

Evaluation of an enrichment programme for a colony of long-tailed macaques (Macaca fascicularis) in a rescue centre

Evaluation of an enrichment programme for a colony of long-tailed macaques (Macaca fascicularis) in a rescue centre

Comparison of the immunogenicity & protective efficacy of various SARS-CoV-2 vaccine candidates in non-human primates

Safety testing of monoclonal antibodies in non-human primates: Case studies highlighting their impact on human risk assessment

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