iN-KEY – Enhancing cell therapies with genomic techniques for next-generation iPSC-derived CAR/STAb NK therapies

iN-KEY: Enhancing cell therapies with genomic techniques for next-generation iPSC-derived CAR/STAb NK therapies aims to develop a new generation of off-the-shelf, genome-edited iPSC-derived NK cell therapies for multiple myeloma. The project combines induced pluripotent stem cell (iPSC) engineering, CAR/STAb technologies, scalable GMP manufacturing, and advanced regulatory and translational strategies to create safer, more accessible, and cost-effective cell therapies.  

The project follows a full translational pipeline from platform design to clinical application. It includes development of engineered haplo-compatible iPSC lines, GMP-compliant manufacturing processes, preclinical validation, and preparation of a first-in-human clinical trial.  

iN-KEY also focuses strongly on regulatory readiness, exploitation, dissemination, and market uptake. Through continuous interaction with EMA and national authorities, development of regulatory guidance tools, and activities related to IP protection and commercialisation, the project aims to strengthen Europe’s leadership in advanced therapy medicinal products (ATMPs) and genome-edited immunotherapies.  

Consortium 

The iN-KEY consortium brings together expertise across molecular genetics, genome engineering, immunology, GMP manufacturing, regulatory science, translational medicine, clinical oncology, and patient engagement. Partners include academic institutions, hospitals, biotechnology companies, regulatory experts, and patient organisations collaborating across the full development pathway from early innovation to clinical translation.  

The consortium integrates capabilities in iPSC engineering, CAR/STAb development, scalable manufacturing, preclinical and clinical validation, regulatory strategy, exploitation, and dissemination, ensuring that scientific advances are supported by strong translational, regulatory, and commercial frameworks.  

EATRIS’ role in the project 

EATRIS ERIC leads WP5 – Regulatory Strategy and Compliance, supporting the regulatory readiness and clinical translation of the iN-KEY medicinal product. EATRIS coordinates activities related to regulatory roadmap development, EMA and national authority engagement, IMPD and CTA preparation, and regulatory guidance for genome-edited iPSC-derived CAR/STAb NK therapies.  

EATRIS also contributes to WP6 – Exploitation and IP Management, supporting IP monitoring, freedom-to-operate analyses, market intelligence, and exploitation planning to facilitate future commercialisation and uptake of the platform.  

Through its expertise in translational medicine and ATMP development, EATRIS helps ensure that the project outputs are regulatorily robust, clinically translatable, and aligned with evolving European regulatory frameworks for advanced therapies.