October 22, 2026 | Miltenyi Biotec joins European iN-KEY project to advance an “off-the-shelf” immunotherapy for a hard-to-treat blood cancer

Bergisch Gladbach, Germany, October 22, 2026 - Miltenyi Biotec has joined iN-KEY, a European consortium developing an "off-the-shelf" cell therapy for multiple myeloma. Unlike current patient-specific cell therapies, the approach aims to create a treatment that can be produced in advance, stored, and made available when needed.

As a core technology partner for automated cell processing, Miltenyi Biotec contributes to the development of a GMP-compliant, scalable manufacturing process for induced pluripotent stem cell (iPSC)-derived hematopoietic precursor and subsequent NK cells using its CliniMACS Prodigy^® Platform. The work includes establishing NK precursor cell banks, adapting production to automated closed systems, and transferring the workflow into GMP environments. Miltenyi Biotec will also provide its adherent cell culture system to support iPSC expansion and differentiation.

A different approach

Although treatment options have improved considerably in recent years, multiple myeloma remains incurable and most patients eventually relapse. Advanced cell therapies such as CAR T cells have shown promising results but require patient-specific manufacturing, a costly process that can take several weeks.

iN-KEY seeks to address these challenges by generating therapeutic cells from iPSCs, a renewable and standardized cell source that can be prepared and stored in advance. Because one manufacturing batch could potentially serve multiple patients, this approach may help simplify production and improve access to advanced cell therapies.

The therapy uses NK cells, which can be generated from donor-derived cells. These cells are genetically engineered to recognize and attack myeloma through two complementary mechanisms: Chimeric Antigen Receptor (CAR) and bispecific antibodies. This dual approach is intended to make tumor escape more difficult. The cells also carry a built-in safety switch that allows them to be deactivated if necessary.

Thanks to a high-capacity gene-loading technology, the cells are equipped with several booster genes that may further improve their effectiveness. Demonstrating this approach, first in the laboratory and then in patients, is the project's central challenge.

"What makes iN-KEY special is not only its potential as a novel therapy for multiple myeloma, but also the platform technology behind it. By combining a versatile stem cell platform with an automated, closed manufacturing approach, the concept may provide a foundation for developing cell therapies for other cancers and infectious diseases in the future," says Kathrin Godthardt, Group Leader Miltenyi Biotec and Principal Investigator iN-KEY.

From laboratory development to clinical testing

As of October 1, 2026, the five-year project will engineer the therapeutic cells, establish a scalable and automated GMP manufacturing process, evaluate efficacy and safety in laboratory and preclinical models, and work with European regulators to define a path toward clinical application.

"A central aspect of iN-KEY is the integration of automation and closed-system processing from an early stage. This will help evaluate how iPSC-derived NK cell therapies can be manufactured in a consistent and reproducible way and translated into clinical development," says Sebastian Knöbel, Senior Scientific Director R&D Regenerative Stem Cells.

The project is planned to culminate in a clinical trial involving 15 patients at the Hospital de Bellvitge in Barcelona.

Patient involvement is integrated throughout the projects. Through Myeloma Patients Europe (MPE), the consortium's patient association, people living with multiple myeloma will help set project's priorities and review key aspects of the clinical trial, from its design to the information given to participants.

A European consortium

The consortium is coordinated by Banc de Sang i Teixits (BST) and brings together expertise from academic and clinical research, biotechnology, manufacturing, regulation and patient advocacy. Alongside BST and Miltenyi Biotec, the partners are the Spanish National Research Council, AVANTHER Therapeutics, STAB Therapeutics, the Spanish National Cancer Research Centre, the French Alternative Energies and Atomic Energy Commission, Paul-Ehrlich-Institut, Catalent, EATRIS, the Institut Català d'Oncologia, and Myeloma Patients.

Disclaimer: Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HADEA). Neither the European Union nor the granting authority can be held responsible for them.