XNK Therapeutics AB (“XNK”) today announced the successful completion of the building phase of the company’s new GMP clean room facility.
All equipment and systems are now installed, and qualification of the clean room is complete, while validation and qualification of equipment and systems are progressing according to plan. The first technical batch has been produced in the facility, demonstrating the ability to run a production process.
“XNK has worked hard over the past year planning for this new GMP facility that will enable the aseptic production of ATMPs and clinical material for future studies,” said Paul Do, Head of Clinical Manufacturing and Engineering at XNK Therapeutics. “This is an important step in the company’s ambitious growth plan to enable further larger clinical studies with our natural killer cell-based therapies.”
The GMP facility comprises approximately 350 square meters and includes 150 square meters of clean rooms, quality control (QC) lab, storage for materials and end product, and office space. The facility is located at the Novum research park at Karolinska University Hospital in Huddinge, Sweden.
For more information, please contact:
Johan Liwing, CEO, XNK Therapeutics
Tel: +46 706 70 36 75
About XNK Therapeutics AB
XNK Therapeutics is a clinical stage, immunotherapy company focusing its efforts on preventing and treating cancer by developing novel NK cell-based therapies. The company is at the forefront of the development of autologous NK cell-based products using its proprietary technology platform. The company’s platform technology and lead investigational candidate drug was developed specifically to target cancers, including settings where allogeneic cell products are not readily applicable. The Company’s objective is for its investigational candidate drug and proprietary platform technology to constitute key components in the cancer treatments of tomorrow. XNK Therapeutics is headquartered in Stockholm, Sweden. For more info, please visit www.xnktherapeutics.com.
About XNK Therapeutics’s technology platform
The platform 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 the NK cell-based products. The process includes a selective expansion and activation of NK cells from peripheral blood of patients with cancer. The product is produced in less than three weeks. It is delivered to the clinic upon need, where the product is thawed and infused into the patient without any further processing. The product has demonstrated an up to 10-year stability in liquid nitrogen. The assets of XNK Therapeutics are protected by patents in the US, Europe and certain other jurisdictions. Additional patent applications have been filed.