Engineered chimeric antigen receptor (CAR) and T-cell receptor (TCR) T-cells are a transformative new form of therapy that involves removing immune cells from patients with cancer, modifying them so that they are better able to find and fight cancer.
A number of challenges arise because engineered cell therapy is a complex therapeutic approach that works by modifying complex systems within the body. The field needs better models to predict which new therapies will be successful, standards for processes, improved regulations, better awareness of engineered cell therapy and the barriers to access.
To reduce the barriers that are slowing down the development and are limiting access to engineered T cell therapies in Europe, the T2EVOLVE consortium will seek to achieve 6 central objectives:
1. Optimization of pre-clinical (laboratory) models, tools, and pharmacodynamic (PD) markers to better predict toxicity and efficacy of engineered T cell therapies before they enter clinical trials.
2. Definition of gold standard analytical methods pre- and post-T-cell infusion and harmonization of product characterization, release testing, monitoring, long-term (e.g. genomic safety) assessment, to enable inter-product comparability, value attribution, and the development of sustainable reimbursement.
3. Selection of optimal lymphodepletion regimens (pre-treatment chemotherapy) by drawing insights from existing data from the clinical monitoring of T cell therapy administration with validation in preclinical and computational models.
4. Production of GMP (Good Manufacturing Practice) guidance and establishment of standard product profiles for autologous and allogeneic engineered T cells to enable production at industry scale and quality, to improve the regulatory process, and to foster dialogue with policymakers.
5. Integrate patient stakeholders into the research and development life cycle of engineered T cell therapy and improve patient experience and interaction with health care practitioners through the joint creation of innovative communication, education, and training tools.
6. Facilitate the expansion of patient access by formulating the outputs of T2EVOLVE in the context of an economic analysis (HTA) to pose recommendations on best paths forward to ensure broad patient access and how engineered T cell therapy could be made more affordable.
Why is T2EVOLVE important to society?
Engineered cell therapy has the potential to offer effective treatment for cancer and other conditions that otherwise would go untreated, leading to increased suffering and death. To realize this potential, T2EVOLVE is aiming at the following key impacts:
• Safer and more effective engineered cell therapies
• Increased access to engineered cell therapy
• Increased health care provider and public awareness of engineered cell therapy
• Accelerated development of new engineered cell therapies
• Increased industrial competitiveness in Europe.
