Page 36 - SaxoCell Annual Report 2021

CAR-NK 4.0

This collaboration project is focusing on the development of a platform technology for the
automated manufacturing of allogeneic chimeric antigen receptor natural killer (CAR NK) cells for
the treatment of specific cancerous diseases. Besides the promising results obtained in the
therapy of B cell malignancies using CAR T cells, conclusive concepts for treatment of myeloid
neoplasms and malignant tumors are still missing. One of the biggest hurdles in the
development of autologous (CAR T) cell therapies is the impaired quality and functionality of the
patient’s own immune cells. To conquer some of these obstacles expertise from academic
(Fraunhofer IZI) and industry partners (Affimed GmbH; Miltenyi Biotec B.V. & Co. KG) as well as
SaxoCell Projects this CAR-NK 4.0 project. In this context, NK cells of healthy donors will be used as promising
from two hospitals (Universitätsklinikum Leipzig; Klinikum Chemnitz gGmbH) is bundled within

starting material for the manufacturing process allowing for allogeneic cell therapies.

The project scope is covering the whole value chain of an advanced therapy medical product
comprising pre-clinical development, process optimization and the translation to a GMP-
compliant CAR-NK manufacturing process. In detail, three aims are addressed: (i) development
of an automated AI-assisted CAR-NK cell manufacturing platform (ii) pre-clinical investigation and
preparation of a phase I study with an allogeneic CD123-addressing CAR-NK approach treating
myeloid neoplasms (iii) increase of the therapeutic efficiency of CAR-NK cell therapy and its
manufacturing by implementing novel technologies, such as a bi-specific target approach,
optimized AAV gene transfer method, and a new cell activation approach.

Project Manager: Prof. Dr. Dr. Ulrike Köhl

Project Partners: Fraunhofer IZI, University Hospital Leipzig, University of Leipzig, Chemnitz
Hospital, Affimed, Miltenyi Biotec

31