SMF AdBioPro: Enable the point-of-care manufacturing of CellProtect for confirmatory clinical trials in Sweden

Important results from the project

The purpose and objective of the project has been to establish a scalable manufacturing protocol for GMP production of CellProtect in Sweden to enable more comprehensive clinical trials. During the project period, the manufacturing method and associated quality documentation (CMC) for CellProtect has been prepared and thereafter approved by relevant authorities. A randomized clinical phase 2 trial (ISA -HC-NK) where CellProtect is one of the trial products has been initiated and active recruitment of patients is ongoing. The work has been carried out in cooperation with others. .

Expected long term effects

XNK´s unique and patent-protected manufacturing method and its controls have been significantly strengthened. The new process for preparation of starting material (WP 1) has been included in the current manufacturing method TM65: 2 for CellProtect. Validation of analysis methods for characterization of end product entails measurements of important parameters with increased precision and variations in the individual productions can be better mapped (WP 2 and 3). Clinical manufacturing of CellProtect has been established at KCC Vecuras in accordance with their quality system.

Approach and implementation

Preparation and implementation of the clinical trial ISA -HC-NK where CellProtect is tested in combination with Isatuximab vs Isatuximab alone is a collaboration between KI, Karolinska Universitetsjukhuset, Huddinge, Sanofi and XNK Therapeutics and the parties respective areas of expertise and associated responsibilities. The opportunity for XNK to participate in this study is a valuable step for the continued clinical development of CellProtect. An expanded GMP manufacturing capacity is under construction and the clinical development program can be broadened.