XNK Therapeutics receives EMA scientific recommendation for evencaleucel as an Advanced Therapy Medicinal Product

January 15, 2024

XNK Therapeutics AB (“XNK”) today announced that evencaleucel has received a scientific recommendation from the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA). This recommendation classifies evencaleucel as a Somatic Cell Therapy Medicinal Product (sCTMP) within the category of Advanced Therapy Medicinal Products (ATMPs).

XNK’s platform, which is used for the manufacturing of evencaleucel, has ideal properties to produce autologous NK cell-based drug candidates for targeting malignant diseases across a wide range of indications in mono- and combination therapy. It encompasses a unique closed manufacturing system for development of NK cell-based products. The process includes a selective expansion and activation of NK cells from peripheral blood of patients with cancer.

“We are very pleased with EMA’s scientific recommendation. This is a necessary step in our regulatory approval journey and will make future interactions easier with the authorities,” said Peter Hovstadius Chief Medical Officer at XNK.

For more information, please contact:

Johan Liwing, CEO, XNK Therapeutics

Tel: +46 706 70 36 75

E-mail: johan.liwing@xnktherapeutics.com

About XNK Therapeutics AB

XNK Therapeutics is a clinical stage immunotherapy company focused on bringing new and more effective treatments to cancer patients. The company is at the forefront of autologous NK cell-based cell therapy development with a proprietary technology platform and a pipeline spanning both hematological malignancies and solid tumor indications. The most advanced product, evencaleucel, is in phase II studies in combination with the CD38 antibody isatuximab targeting multiple myeloma. Other programs include XNK02 in AML, currently in advanced preclinical studies in collaboration with MD Anderson Cancer Center and XNK03 in bladder cancer, currently in preclinical studies in collaboration with the Karolinska University Hospital. XNK’s efforts are supported by a dedicated team that include world-renowned NK cell experts and by an approved in-house GMP facility. XNK Therapeutics is headquartered in Stockholm, Sweden. For more info, please visit http://www.xnktherapeutics.com.