Page 36 - SaxoCell Annual Report 2021
P. 36

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




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