NEW YORK – A group of 27 partners from nine European countries said on Wednesday that they have formed an alliance focused on advancing cell therapy research and access throughout the European Union.
The new alliance, dubbed T2EVOLVE, will receive funding from the EU's Innovative Medicines Initiative.
Alliance partners include academic and non-academic research facilities, pharmaceutical and biotech companies, professional organizations, regulatory bodies, and patient groups. Michael Hudecek of the University Hospital Würzburg in Germany is coordinating the consortium and Hélène Negre of Servier Laboratories in France will lead it. Pharma companies Bayer, Astellas, Celgene-Bristol Myers Squibb, Janssen, and Takeda are among the leading industry partners, and the European Hematology Association and the European Cancer Patient Coalition are among the association partners.
The T2EVOLVE alliance members agree although cell therapies have the potential to be truly curative for many cancer types, Europe is lagging behind other regions in terms of advancing these therapies into clinical trials and the EU market. Recognizing this, the members aim to accelerate development and awareness of T-cell receptor and CAR T-cell therapies, while providing the EU healthcare system with guidance as to how best to implement these therapies.
T2EVOLVE has laid out five goals, including optimizing pre-clinical models for predicting safety and efficacy of these therapies; defining a "gold standard" method for monitoring patients; standardizing lymphodepletion regimens; establishing standard product profiles for cell therapies through Good Manufacturing Practice guidance; working with stakeholders to improve patients' experiences; and increasing access to these therapies.