Published: 12-07-2023 17:35 | Updated: 06-05-2024 09:51

New center to strengthen investment in cell, gene and tissue therapies

Aula Medicas facade with it´s glass windows
Photo: Liza Simonsson.

Karolinska University Hospital's Director Björn Zoëga and Karolinska Institutet's President Annika Östman Wernerson have signed an agreement to establish a joint center for advanced cell, gene and tissue therapies.

Internationally, these therapies are also referred to as "Advanced Therapy Medicinal Products" (ATMP). The new centre, which operates in both Huddinge/Flemingsberg and Solna, will be named Karolinska ATMP Centre.

The major advances in research and development of advanced medicines in the field of cell and gene therapy have the potential to treat and cure diseases that could not have been cured by traditional medicines.

Björn Zoëga. Photo: Danish Saroee.

"We already see examples of gene therapy drastically improving the survival of patients with certain types of cancers. Advances in ATMP and other precision medicine will change the way healthcare is conducted. We must increase the pace of introducing the new treatments, to cure more people but also to make socio-economic gains,” says Björn Zoëga, hospital director at Karolinska University Hospital.

Karolinska Institutet and Karolinska University Hospital are together among the European leaders in advanced cell and gene therapy regarding research, manufacturing and treatment. The Department of Cell Therapy and Allogeneic Stem Cell Transplantation (CAST) was one of the first of its kind in Europe when founded in 1975 in Huddinge.

Multiple ATMP drugs

CAST and the affiliated areas of transfusion medicine and pediatrics are JACIE-accredited, which is the Europe’s official accreditation body in the field of haematopoietic stem cell transplantation and cellular therapy.

The department performs blood stem cell transplantation and advanced cellular therapy in both pediatric and adult patients with aplastic anemia, autoimmune diseases, inborn genetic errors, hemoglobinopathies, MDS, leukemia, lymphoma, myeloma and even certain solid tumors. Sweden's first standard treatment with CAR-T cells was performed here in 2019 reflecting the ongoing paradigm shift towards more and more patients being treated with ATMPs in both standard of care and clinical trials.

Sweden’s first gene therapy drug for clinical trials was produced 1997 under Good Manufacturing Practice (GMP) at Vecura as part of Karolinska Center for Cell Therapy (KCC) in Huddinge. Here, the first CAR-T cells that went into a clinical trial in Europe were produced as early as 2014. Today Vecura consists in 13 clean rooms and there is a further GMP facility with a special focus on immunotherapy located at Karolinska Comprehensive Cancer Center (KCCC) in Solna.

The first pre-GMP unit

The Nordic’s first pre-GMP unit was inaugurated at Karolinska Institutet’s Campus Flemingsberg in 2019 including five clean rooms. This pre-GMP unit is an important bridge between research laboratories and Vecura and has already been instrumental in the development of two therapeutic products that are currently tested in clinical trials.

Annika Östman Wernerson
Annika Östman Wernerson. Photo: Martin Stenmark.

"The paradigm shift taking place in healthcare today is about medical research finding solutions in healthcare with the help of new technological achievements. The establishment of the Karolinska ATMP Centre aims to do that, by strengthening collaboration between research and clinic, we will speed up the application of research for the implementation of new gene, cell and tissue therapies that help the patient," says Karolinska Institutet's President Annika Östman Wernerson.

"Together with our industry partners, other regions and universities around the world, Karolinska ATMP Centre can make important contributions to the development of new ATMP therapies," concludes Annika Östman Wernerson.

The Karolinska ATMP Centre will be funded in equal shares by Karolinska University Hospital and Karolinska Institutet. The centre will gather the development of cell, gene and tissue therapy in one organization, and it will participate in national and international collaborations.

This will strengthen the collaboration with neighboring regions and pharmaceutical companies.