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An IQ Consortium Perspective on Best Practices for Bioanalytical and Immunogenicity Assessment Aspects of CAR-T and
Jochem Gokemeijer1, Nanda Balasubramanian2, Ken Ogasawara2
1Discovery Biotherapeutics, Bristol Myers Squibb, Cambridge, Massachusetts, USA.
Abstract:
CAR-T therapies have shown remarkable efficacy against hematological malignancies in the clinic over the last decade and new studies indicate that progress is being made to use these novel therapies to target solid tumors as well as treat autoimmune disease. Innovation in the field, including TCR-T, allogeneic or "off the shelf" CAR-T, and autoantigen/armored CAR-Ts are likely to increase the efficacy and applications of these therapies. The unique aspects of these cell-based therapeutics; patient-derived cells, intracellular expression, in vivo expansion, and phenotypic changes provide unique bioanalytical challenges to develop pharmacokinetic and immunogenicity assessments. The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Translational and ADME Sciences Leadership Group (TALG) has brought together a group of industry experts to discuss and consider these challenges. In this white paper, we present the IQ consortium perspective on the best practices and considerations for bioanalytical and immunogenicity aspects toward the optimal development of CAR-T and TCR-T cell therapies.
Insights
Chimeric antigen receptor T-cell (CAR-T) therapies show promise for treating solid tumors and autoimmune diseases. This paper outlines best practices for bioanalytical and immunogenicity assessments to optimize CAR-T and T-cell receptor T-cell (TCR-T) therapy development.
Area of Science:
- Cellular immunotherapy
- Pharmacokinetics and pharmacodynamics
- Immunogenicity assessment
Background:
- Chimeric antigen receptor T-cell (CAR-T) therapies have demonstrated significant clinical success in hematological malignancies.
- Emerging research indicates potential applications for CAR-T therapies in solid tumors and autoimmune diseases.
- Innovations such as T-cell receptor T-cell (TCR-T), allogeneic CAR-T, and armored CAR-Ts are expanding therapeutic possibilities.
Purpose of the Study:
- To address the unique bioanalytical challenges associated with cell-based therapeutics like CAR-T and TCR-T therapies.
- To present the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Translational and ADME Sciences Leadership Group (TALG) perspective on best practices.
- To guide the optimal development of pharmacokinetic and immunogenicity assessments for these advanced therapies.
Main Methods:
- Industry expert consensus building within the IQ TALG.
- Discussion and consideration of bioanalytical challenges specific to cell-based therapeutics.
- White paper compilation of best practices and considerations.
Main Results:
- Identification of unique bioanalytical challenges including patient-derived cells, intracellular expression, in vivo expansion, and phenotypic changes.
- Development of a consortium perspective on essential considerations for bioanalytical and immunogenicity assessments.
- Framework for optimizing the development of CAR-T and TCR-T cell therapies.
Conclusions:
- Standardized bioanalytical and immunogenicity assessments are crucial for advancing CAR-T and TCR-T therapies.
- Addressing these challenges will enhance the efficacy and broaden the applications of cell-based immunotherapies.
- The IQ consortium provides valuable guidance for the pharmaceutical development of these innovative treatments.
