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

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.

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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!