XNK TherapeuticsEvencaleucel gains EMA recommendation

临床2期基因疗法细胞疗法免疫疗法
Supporting XNK Therapeutics’ work is a team that includes experts in NK cell research. Credit: Gorodenkoff/Shutterstock.com.
XNK TherapeXNK Therapeuticsbased 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.
XNK Therapeuticson places Evencaleucel within the category of Advanced Therapy Medicinal Products. The pEuropean Medicines Agencyo maEMAacture the product is designed to produce autologouEvencaleucelller (NK) cell-based drug candidates.
Evencaleuceles are developed to act on malignant ailments, both as mono and combination therapies.
The platform features a clEvencaleucelturing system, which is pivotal for developing NK cell-based products.XNK
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 cancery along with isatuximab, a CD38 antibody, to treat multiple myeloma.
XNKther asset, XNK02, is in advanced preclinical studhaematological malignancies MD Asolid tumoursr Center to potentially treat acute myeloid leukaemia.
Evencaleucel at treating bladder cancer, is in preclinical studies in partnership with the Karolinska University Hospital.isatuximabCD38multiple myeloma
Supporting XNK XNK02peutics’ innovative work is a team that includes experts in NMD Anderson Cancer CenterCanceracute myeloid leukaemia
XNK03ompany also benefitsbladder cancerved in-house good manufacturing practice facility.Karolinska University Hospital
XNK TherapeXNK Therapeuticscal 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.”
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
XNK Therapeuticst is independently produced and follows the highest standards of journalisEMA integrity. Topic sponsors are not involved in the creation of editorial content.
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