Is Your Biotherapeutic Immunomodulatory? How to Use Immunoassays to Get the Right Answer

Biotherapeutics are a class of large medicinal products that are being increasingly used for various medical applications including vaccination, therapeutic drug delivery systems and the treatment of human diseases. Biotherapeutics offer the advantages of increased specificity and reduced toxicity compared to small molecules. However, they can inappropriately activate the immune system. This potential biotherapeutics-mediated immunogenicity must be assessed as early as possible during drug development since it can be the cause of serious events such as autoimmunity, inflammation, anti-drug antibodies (ADAs) production, hypersensitivity reactions (allergenicity) or cytokine storm syndrome. Moreover, since biotherapeutics are produced using biological means, the development of biosimilars must include comparative immunogenicity and biological assay testings.

Immuni T has developed numerous tools and assays for assessing the immunogenicity, immunomodulatory qualities and functional activity of biotherapeutics, vaccines and biosimilars that are useful from early development to late clinical phase. The presentation will focus on an ex vivo assay performed in primary human or animal peripheral blood mononuclear cells (PBMCs) or rodent splenocytes, with examples on how to use and interpret the data for early safety screening as well as in support for biosimilarity in regulatory data package submissions. Concrete examples will be shown using various biological outcomes that can be measured at different stages of immune cell activation, including cytokine secretion, expression of cellular activation markers and proliferation.

T and B lymphocyte subsets, NK cells, monocytes, macrophages, dendritic cells and cytokines are all involved in a complex manner to determine the intensity, orientation, and duration of the immune response through the expression of cellular and molecular markers. A number of immunoassays based on ligand binding, flow cytometry, and cellular assay platforms were developed and implemented at Immuni T to support better and safer drug development. Therefore, ex vivo immunogenicity assays are pivotal to evaluate the risk of immunogenicity and immunomodulation, and to gain awareness as early as in the discovery phase.

In conclusion, immunosafety assays of biotherapeutics to assess their propensity to elicit undesirable immune responses are an essential part of their development. Overall, the possibility of shaping immune reactivity with biotherapeutics to control their respective risk of immunogenicity or allergenicity would be extremely beneficial for the optimization of safety and efficacy.

This webinar will educate the participant on a variety of immunomodulatory assays to measure and assess immune responses and to provide data that may help in developing novel immunomodulatory agents.

Speakers

Luc Villeneuve, President and Chief Executive Officer, Immuni T

Dr. Villeneuve is the Founder, President & CEO of Immuni T with over 40 years of experience in the life science sector. He received his Ph.D. from the McGill Experimental Medicine faculty. Prior to the founding of Immuni T, Dr. Villeneuve was VP and CSO at Theratechnology as well as VP Cell Therapy and Scientific Affairs at Celmed Biosciences. Under his guidance, several cell therapy platforms composed of a drug and a medical device were developed up to Phase III clinical trials. Dr. Villeneuve also successfully presided over several meetings with the FDA and other regulatory agencies. Dr. Villeneuve leads the Immuni T team with the precision, calm and focus necessary for excellence from the client’s prospective. Dr. Villeneuve has consistently been active in the immunology field and is now working on using his knowledge about drug, medical devices and biotherapeutics to bolster Immuni T’s clients’ drug development programs.

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Idriss Saiah, Chief Scientific Officer, Immuni T

Dr. Idriss Saiah joined Immuni T as Senior Research Scientist in December 2016. Prior to Immuni T, Dr. Saiah was a Researcher at Hospital Ste-Justine and Immunology department of University of Montreal, where he supervised graduate and post-graduate students and post-doctoral fellows in research. During that time he also taught many courses in immunology.

Dr. Saiah earned his Ph.D degree in immunology from Paris IV University and was FRM post-doctoral fellow at INSERM U25 (Necker hospital, Paris, France) whose works on the immune system were at the forefront for the development of new strategies in immune therapies.

Dr. Saiah’s research interests included basic and clinical aspects of autoimmune and inflammatory diseases. He has published works concerning the association of candidate genes with various autoimmune diseases including type 1 diabetes, celiac disease, autoimmune hepatitis and autoimmune thyroiditis.

He has also experience in analysis of clinical data in correlation with genetic profiles and in experimental autoimmunity including human autoantibodies and the production and analysis of transgenic mouse models for understanding the pathogenic mechanisms of immune tolerance.

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