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INV11

T2EVOLVE: Standardization of preclinical and clinical development of engineered T-cell therapy in Europe—a cross-functional multi-stakeholder initiative

H Negre* ¹

1: Institut de Recherches Internationales Servier, Suresnes, France

* on behalf of the T2EVOLVE Consortium

T2EVOLVE is a breakthrough alliance of academic and industry leaders in cancer immunotherapy, under the EU’s Innovative Medicines Initiative. The key objective of T2EVOLVE is to accelerate development and increase access for cancer patients to engineered T-cell therapy.


T2EVOLVE screened the landscape of available preclinical models for evaluating safety and efficacy of engineered T-cell therapies and identified unmet needs and gaps to define its research roadmap. Using innovative technologies—such as organotypic tissue slices, 3D tumor models and advanced microscopy—T2EVOLVE aims to develop new validated preclinical models and test parameters with higher predictive value for clinical safety and efficacy. The consortium intends to set new standards for preclinical development, immunomonitoring assays and GMP processes. An analytical methods survey is running whose results will be used to develop new analytical standards, with focus on immunomonitoring. Early engagement with the EMA’s Innovation Task Force on these topics, with intent for continuing dialogue, has informed the T2EVOLVE regulatory strategy.


By engagement with patients and carers, the consortium will collect information from those with direct experience of engineered T-cell therapy to identify challenges, educational needs, and information gaps. A Working Group composed of patients, carers and patient organization representatives was established. Two workshops were held in 2021 to inform the Working Group about T2EVOLVE, gather their views and keep the T2EVOLVE research agenda patient-centered. 

T2EVOLVE is developing new standards that will be validated by the consortium to provide investigators with innovative assays and guidelines for improved preclinical development, immunomonitoring and GMP manufacturing.

Acknowledgement:
This project received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 945393. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation program and EFPIA. More information can be found at: https://www.imi.europa.eu/



PLEASE COMPLETE OUR SURVEY

We are very pleased to finally launch the European survey related to analytical controls of engineered T-cells.


To ensure the best success, quality and representativity of survey’s results, we count on your participation to fill and share this survey through your network.

Anyone involved in the field of engineered T-cells (academic, private, hospital, industry, CRO, CMO, etc.) can answer the survey and help us picturing current practices


ACCESS & SHARE THE SURVEY

(before April 13th)

https://com4survey.online/validation?survId=23d3ab0a-569d-4f55-9abd-965ace717659&language=en


Passphrase to enter the survey :

T2EVOLVE

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