Abstract
Background: The mission of medicines regulatory agencies is to ensure the timely access of innovative products for patients to improve public health. Thus, regulators should foresee evolving technologies and build expertise prior to reviewing innovative products. Novel modalities and new classes of therapeutics in biological or cell-based products represent a regulatory challenge because of knowledge gaps, as exemplified by the unexpected cytokine release syndrome in the first-in-human clinical trial of the CD28 super-agonist. Meanwhile, recent treatments harnessing T cell co-signaling pathways provide an opportunity for investigation. Therefore, this study aimed to systematically identify and evaluate novel modalities for T cell immunity to assess the need for regulatory guidance.Methods: A PubMed search was carried out using the query, “immun* AND t lymph*” to select publications. Subsequently, a citation network was created, followed by clustering and text mining to identify the modalities and classes of therapeutics under development.Results and Discussion: Analysis of the top 20 clusters revealed research domains characterized by keywords such as immune checkpoint antibody, chimeric antigen receptor (CAR)-T cells, microbiota, exosome, regulatory T cells, unconventional T cells, and vaccines. After reviewing the pharmacological concepts, clinical trial information, and available guidance, we presented a perspective on the future development of guidance for these domains.Conclusion: Bibliometric analyses identified a set of innovative modalities targeted for drug development with which regulatory guidance is going to catch up. This strategy could help in the successful development of upcoming modalities to ensure readiness for clinical application as part of horizon scanning.
Highlights
Our mission as medicines regulatory agency is to protect and promote public health
The clusters were arranged in descending order of the number of included constituent papers (Supplementary Figure 1); the top 20 clusters were used for subsequent analyses, which covered 95.3% of papers in the citation network
The keywords for cluster 13 were characterized by unconventional T cells, such as invariant NKT cells and mucosal-associated invariant T (MAIT) cells
Summary
We achieve our mission through regulatory science, which underlies the objective evaluation of the safety, efficacy, and quality of medical products and supports science-based decision-making. Novel modalities in biological or cell-based products represent a regulatory challenge in terms of efficacy, safety, and quality because of the heterogeneous nature of the product and the multifaceted mode of action. The mission of medicines regulatory agencies is to ensure the timely access of innovative products for patients to improve public health. Novel modalities and new classes of therapeutics in biological or cell-based products represent a regulatory challenge because of knowledge gaps, as exemplified by the unexpected cytokine release syndrome in the first-in-human clinical trial of the CD28 super-agonist. This study aimed to systematically identify and evaluate novel modalities for T cell immunity to assess the need for regulatory guidance
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