XNK receives certificate of GMP compliance of a manufacturer from the Medical Products Agency
XNK Therapeutics today announced that it has received a GMP manufacturing license and a certificate of GMP compliance from the Swedish Medical Products Agency, which means that the company can produce at scale for its planned clinical studies.
“We are very happy to receive this license. It is an important milestone for XNK, and we are now well positioned for significant value creation with three to four potential phase I/II readouts in our pipeline over the coming three years. The in-house GMP facility provides us with valuable capacity, flexibility and control over our clinical manufacturing which brings competitive advantages going forward. In addition, the close collaboration and proximity between manufacturing and research & innovation ensures efficient process development and organizational learning,” said Johan Liwing, CEO, 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.
“I am proud of the team which has worked hard over the past 18 months to build and validate our new GMP facility and a regulatory compliant Pharmaceutical Quality System. This will enable us of aseptic production 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.
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.