Built around a twelve-partner European consortium, the initiative will create a new line of immunotherapies using “Natural Killer cells” generated from stem cells. With funding of almost €10 million, the project brings together several genetic technologies developed by Spanish research groups. The initiative builds on years of collaboration between CSIC and the Banc de Sang i Teixits in the genetic engineering of stem cells to fight a range of diseases.
A European consortium with the participation of major Spanish research centres will develop an “off-the-shelf” cell therapy against multiple myeloma, the second most common blood cancer and a disease that remains incurable. The twelve-partner consortium — six of them Spanish — will deliver a therapy that, unlike current cell immunotherapies, which must be manufactured individually for each patient after diagnosis, will be available in hospitals like any other standard medicine, reducing both waiting times for patients and the costs of treatment.
Over five years, the project, called iN-KEY, will take the therapy from the laboratory to the clinic in several stages: it will engineer the therapeutic cells with a precision technology that inserts the necessary genes safely and reliably into the stem cells; develop a scalable, automated manufacturing process that meets the strict quality standards required of medicines (GMP); then rigorously test the cells’ efficacy and safety in advanced laboratory and preclinical models; work closely with European regulators from the outset to define the approval pathway for this new class of therapies; and culminate in a clinical trial in 15 patients to assess the therapy’s safety.
iN-KEY is backed by funding of close to €10 million awarded by the European Union. It begins in October 2026 and run for five years.
“This funding recognises years of work and gives us the opportunity to bring a truly disruptive technology — based on integrating the latest advances in the field — into the production of a new kind of therapy, closer to the patients who need it most. iN-KEY aims to make advanced cell therapy faster, safer and more accessible,” says Belén Álvarez-Palomo of the Banc de Sang i Teixits (BST), the project’s coordinator.
Multiple myeloma, in context
Multiple myeloma is a cancer of the plasma cells in the bone marrow and the second most common blood cancer. Although more effective treatments have emerged in recent years, the disease remains incurable and patients relapse repeatedly. Those who exhaust the available options after several lines of treatment face a median survival of less than a year.
Today’s most advanced immunotherapies, known as CAR-T cell therapies, are made one at a time, tailored to each patient from their own cells. The process usually costs more than €300,000 per dose and takes five to eight weeks to be ready — a wait many patients with fast-progressing disease cannot afford.
A different approach
iN-KEY turns that approach around. Instead of starting from each patient’s own cells, it will manufacture the therapeutic cells from induced pluripotent stem cells (iPSCs): a renewable, standardised material that can be prepared in advance and stored. Because they come from a bank of lines selected for their compatibility with much of the population, a single batch could serve many different patients. That is the key to “off the shelf”: the therapy is prepared ahead of time and the manufacturing wait disappears, along with much of the cost.
The therapy uses immune-system cells known as natural killer (NK) cells. These carry barely any risk that the transplanted cells will attack the patient’s body — a serious complication known as graft-versus-host disease — and tend to cause far less inflammation. The cells are genetically engineered to recognise and attack myeloma through two complementary mechanisms, a chimeric antigen receptor (CAR) and a bispecific antibody, making it harder for the tumour to escape; they also incorporate a built-in safety mechanism that allows them to be deactivated if necessary.
Thanks to a high-capacity gene-loading technology, the cells also carry several booster genes expected to increase efficacy notably. Proving this, first in the laboratory and then in patients, is the project’s central challenge.
“What makes iN-KEY special is not just the myeloma therapy, but the technological platform behind it. It is designed as a flexible base: by changing the genes we introduce, the same technology can be directed against other cancers or even infectious diseases. In fact, we are already applying it in that direction in other funded projects. In that sense, iN-KEY is the first step in a much broader strategy,” says Daniel Bachiller, Head of the Advanced Therapies Group at CSIC’s Margarita Salas Centre for Biological Research (CIB) and lead for genetic engineering in iN-KEY.
How will the project work?
Patients will not be mere recipients of the therapy: they will play an active part in guiding the research. Through Myeloma Patients Europe (MPE), the consortium’s patient association, people living with multiple myeloma will help set the project’s priorities and review key aspects of the clinical trial, from its design to the information given to participants. This ensures that decisions reflect what really matters to patients and their families.
“For people living with multiple myeloma, time and access are key. An efficient therapy that could be ready in the hospital the moment it is needed, and with fewer side effects, would make a real difference to patients and their families. That is why it matters so much that the patient voice is part of iN-KEY from day one and not only at the end: we take part in the project’s decisions and in the design of the clinical trial so that the research responds to what patients with myeloma really need,” explains Solène Clavreul, Head of Medical Education and Scientific Engagement at Myeloma Patients Europe (MPE).
Another strength lies in the makeup of the consortium, which brings together partners from every stage of drug development: academic and clinical research groups, biomedical companies specialising in manufacturing, a patient association, and partners experienced in engaging with regulatory agencies. Having this full range of expertise from the start is intended to smooth the path from laboratory to clinic.
A consortium built on complementary strengths
iN-KEY’s ambition rests on twelve partners, each a leader in a critical area of the therapy’s development. The Banc de Sang i Teixits (BST) coordinates the project, provides the clinical-grade, compatible stem-cell lines and will carry out the development and manufacturing of the clinical-grade therapeutic cells; the Spanish National Research Council (CSIC), an agency attached to Spain’s Ministry of Science, Innovation and Universities, contributes the gene-loading platform at the heart of the therapy and leads communication; AVANTHER Therapeutics integrates that precision platform into the stem-cell genome; STAB Therapeutics provides its bispecific-antibody technology and leads the efficacy and exploitation studies; the Spanish National Cancer Research Centre (CNIO) contributes its expertise in myeloma biology and preclinical models; the French Alternative Energies and Atomic Energy Commission (CEA) carries out multi-omics safety profiling; the Paul-Ehrlich-Institut (PEI) assesses genomic integrity and safety and advises on regulation; Catalent and Miltenyi Biotec develop the scalable, closed and automated manufacturing process; the European Infrastructure for Translational Medicine (EATRIS) leads the regulatory strategy and engagement with European agencies; the Institut Català d’Oncologia (ICO)–IDIBELL will run the clinical trial at the Hospital de Bellvitge; and Myeloma Patients Europe (MPE) ensures the patient voice shapes the research from the outset.
Learn more on the project page.
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.
