On January 15, 2024 XNK Therapeutics AB (‘XNK’) reported that evencaleucel has received a scientific recommendation from the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) (Press release, XNK Therapeutics, JAN 15, 2024, View Source [SID1234639238]). This recommendation classifies evencaleucel as a Somatic Cell Therapy Medicinal Product (sCTMP) within the category of Advanced Therapy Medicinal Products (ATMPs).

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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.