XNK Receives EU Tissue Establishment Certificate
XNK Therapeutics today announced that it has been approved as an EU Tissue Establishment. This certificate allows the company to take control of the complete manufacturing chain, from withdrawal of blood from the patient at the clinic to the delivery of the finished autologous NK-cell based medicinal product.
“This is another very important milestone for us. From a manufacturing viewpoint, we now have all the permits we need to launch clinical studies within EU. All building blocks are now completed to position us for significant value creation with three to four potential phase I/II readouts in our pipeline over the coming three years” said Johan Liwing, CEO of XNK Therapeutics.
Earlier in March 2023, XNK received a certificate of GMP compliance of a manufacturer from the Swedish Medical Products Agency, which means that the company can produce at scale for its planned clinical studies. XNK’s pipeline is spearheaded by a clinical phase II program in multiple myeloma and the current preclinical programs are within urothelial cancer and acute myeloid leukemia (AML).
“I am proud of the work of our team. This shows our strength as a company to involve representatives from our clinical and manufacturing departments working cross functional to incorporate an additional layer to our quality management system. I can now with confidence say that XNK can handle both the patient blood and personal data in a secure manner, ensuring patient safety and integrity. This enables us of in-house manufacturing of ATMPs for future clinical trials. This is an important step in the company’s ambitious growth plan to enable further larger clinical trials with our natural killer cell-based therapies,” said Linda Brink, Head of QA at XNK Therapeutics.
The building phase of the company’s new GMP clean room facility was completed in September 2022. The GMP facility comprises approximately 350 square meters and is located at XNK in the Novum Research Park, co-located with the Karolinska Institutet and the Karolinska University Hospital in Huddinge, Sweden.
For more information, please contact:
Johan Liwing, CEO, XNK Therapeutics
Tel: +46 706 70 36 75
E-mail: johan.liwing@xnktherapeutics.com
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 the company’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.
