XNK Therapeutics, a Sweden-based immunotherapy company, has received scientific recommendation from the European Medicines Agency's (EMA) Committee for Advanced Therapies for its product Evencaleucel.
Evencaleucel is classified as a Somatic Cell Therapy Medicinal Product.
The classification places Evencaleucel within the category of Advanced Therapy Medicinal Products. The platform utilised by XNK to manufacture the product is designed to produce autologous natural killer (NK) cell-based drug candidates.
The candidates are developed to act on malignant ailments, both as mono and combination therapies.
The platform features a closed manufacturing system, which is pivotal for developing NK cell-based products.
The manufacturing process involves the careful expansion and activation of NK cells derived from the peripheral blood of cancer patients.
XNK has a pipeline that includes treatments for both haematological malignancies and solid tumours.
Evencaleucel is the company's most advanced product and is currently undergoing Phase II clinical trials, evaluating the therapy along with isatuximab, a CD38 antibody, to treat multiple myeloma.
Another asset, XNK02, is in advanced preclinical studies in partnership with the MD Anderson Cancer Center to potentially treat acute myeloid leukaemia.
XNK03, aimed at treating bladder cancer, is in preclinical studies in partnership with the Karolinska University Hospital.
Supporting XNK Therapeutics' innovative work is a team that includes experts in NK cell research.
The company also benefits from an approved in-house good manufacturing practice facility.
XNK Therapeutics chief medical officer Peter Hovstadius stated: “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.”
