Second Phase
1. UniKT
Universal AI-guided designer CAR T-cell therapy against tumor, inflammatory and autoimmune diseases
In order to counter the rising case and mortality rates of difficult-to-treat common diseases such as cancer and autoimmune diseases in the growing and ageing population, we are focusing on the development of innovative immunotherapies using state-of-the-art technology. Based on chimeric antigen receptor (CAR)-modified T cells already successfully used in blood cancer, we plan to develop universal, allogeneic cell therapeutics that are available ad hoc and enable efficient therapy for cancer, inflammatory and autoimmune diseases. Our unique selling points are:
1) The adapter CAR T-cell platform with universal adapter CAR T-cells and indication-specific adapter molecules for targeted switching on/off of T cells.
2) Increased specificity, persistence and tolerability through innovative genome editing processes to switch off the endogenous T cell receptor (TCR).
3) Allogeneic ‘off-the-shelf’ usability through selected healthy cell donors. Our focus is on two products:
- A) UniK-Tackle: Adapter CAR-T effector cells (Teff) for solid tumours, developed through multi-parameter imaging analyses and AI algorithms for precise predictions.
- B) UniK-Tame: Immunosuppressive adapter CAR-T cells (Treg) from umbilical cord blood for the treatment of graft-versus-host disease (GvHD) after stem cell transplantation and autoimmune diseases.
Coordinators
- Anja Feldmann (HZDR) – Institute of Radiopharmaceutical Cancer Research, Helmholtz Centre Dresden-Rossendorf (HZDR)
- Anke Fuchs (CRTD) – Advanced Cellular Therapeutics, Centre for Regenerative Therapies Dresden (CRTD)
Partners
- Frank Buchholz (TUD-Systems) – Medical Systems Biology, Faculty of Medicine Carl Gustav Carus, TU Dresden
- Marc Schmitz (TUD-Immu) – Institute of Immunology, Faculty of Medicine Carl Gustav Carus, TU Dresden
- Martin Bornhäuser (TUD Clinic I) – University Hospital Carl Gustav Carus, Medical Clinic and Polyclinic I, TU Dresden
- Jan Moritz Middeke (TUD Clinic I) – Carl Gustav Carus University Hospital, Medical Clinic and Polyclinic I, TU Dresden
- DKMS StemCellBank gGmbH
- Seamless Therapeutics GmbH
- Cancilico GmbH
2.SafeTy
Development and translation of biotechnological processes for safe T-cell therapy
Cell therapies, such as allogeneic stem cell therapy or CAR T-cell therapy, are important approved options for the treatment of life-threatening haematological cancers. However, these life-saving cell therapies are often associated with severe side effects. The main complication following allogeneic cell therapies is graft-versus-host disease (GvHD). In the course of previously approved autologous CAR-T cell therapies, on the other hand, a strongly excessive immune reaction – the so-called cytokine release syndrome (CRS) – occurs in most cases. With the overarching project goal of making T-cell therapies safer and bringing them into clinical translation, the SafeTy consortium is developing novel technological processes and research approaches with the following sub-goals:(A) The clinical translation of the Saxon ATMP Palintra® for the prevention of GvHD.
(B) Research and transfer of the Palintra® ATMP concept to allogeneic CAR-T cell therapy and to the preventive treatment of CRS with autologous CAR-T cell therapy.
(C) Research into extracorporeal immunomodulation for GvHD therapy using low-energy electron irradiation (LEEI).
(D) Research into extracorporeal immunomodulation using extracorporeal photopheresis (ECP) as a possible therapeutic method for the treatment of CRS after autologous CAR T-cell therapy.
Coordinators
- André-René Blaudszun (FhIZI) – Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology (IZI)
Partners
- Jasmin Fertey (FhIZI) – Department of Vaccines and Infection Modelling, Fraunhofer Institute for Cell Therapy and Immunology (IZI)
- Mathias Hänel & Paul Warncke (KCh) – Clinic for Internal Medicine III, Klinikum Chemnitz gGmbH
- Vladan Vucinic (UKL) – Medical Clinic I – Clinic and Polyclinic for Haematology, Cell Therapy, Haemostaseology and Infectiology, Leipzig University Hospital
- Tcell Tolerance GmbH
- KyooBe Tech GmbH
3.SB-TRACT
Sleeping Beauty Transposon-modifizierte CAR/TCR-T-Zellen
This project aims to develop and automate the production of Sleeping Beauty transposon-modified T cells for the treatment of solid tumours. This is a cooperation project between 3 industrial partners, the academic partners University of Leipzig and Fraunhofer IZI as well as 2 associated partners with the strategic goal of transforming innovative T-cell products into clinical products of the future cluster.
Coordinators
- Sandy Tretbar (FhIZI) – Department of Cell and Molecular Biology, Fraunhofer Institute for Cell Therapy and Immunology (IZI)
Partners
- Michael Hudecek (FhIZI-Wü) – Fraunhofer Institute for Cell Therapy and Immunology (IZI) Würzburg branch office
- Achim Aigner (ULEI) – Institute of Pharmacology, Faculty of Medicine, University of Leipzig
- Haema AG
- T-CURX GmbH
- TheryCell GmbH
Associated Partners
- Cytiva
4. NK-Alliance
Ex vivo-modified natural killer cells for the immunotherapy of tumours and autoimmune diseases
The NK-Alliance is a joint project of academic partners and German biotech companies with the aim of developing widely applicable, effective and cost-efficient cell therapies based on NK cells for the treatment of tumors and autoimmune diseases. The focus is on overcoming current challenges in the clinical use of NK cells. These include:
(i) Increasing the efficacy of NK cells by developing innovative methods for the genetic optimization of NK cells
(ii) Optimizing expansion technologies to achieve clinically relevant cell numbers of a tumor-reactive NK cell subtype or CAR-NK cells
(iii) Translation into clinical application: ensuring the feasibility and efficiency of these technologies to enable testing in clinical trials.
The project will be complemented by pioneering research focusing on the improvement of viral gene transfer systems, the establishment of new manufacturing processes and the generation and optimization of new CARs using innovative bioinformatic in silico designs.
With this integrative approach, we aim to overcome the limitations of existing NK cell therapies, thereby transferring NK cell products into clinical practice in the long term and strengthening Saxony and Germany as a biotech location through the development of innovative technologies and cell therapies.
Coordinators
- Ulrike Köhl (FhIZI) – Director, Fraunhofer Institute for Cell Therapy and Immunology (IZI)
Project Leaders
- Dominik Schmiedel (FhIZI) – Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology (IZI)
- Achim Temme (TUD) – Experimental Neurosurgery/Tumour Immunology, Faculty of Medicine Carl Gustav Carus, TU Dresden
Partners
- Kristin Reiche (ULEI) – Institute for Clinical Immunology at the Medical Faculty of the University of Leipzig & Department of Diagnostics, Fraunhofer Institute for Cell Therapy and Immunology (IZI)
- Anna Dünkel (FhIZI) – Department of Cell and Gene Therapy Development, Fraunhofer Institute for Cell Therapy and Immunology (IZI)
- Jiri Eitler (TUD) – Experimental Transfusion Medicine, Faculty of Medicine Carl Gustav Carus, TU Dresden
- Ulrich Hacker & Hildegard Büning (UKL) – University Cancer Centre Leipzig (UCCL), Leipzig University Hospital
- Clara Schoeder & Jens Meiler (ULEI) – Institute for Drug Development, Faculty of Medicine, Leipzig University
- Jan Ewald & Erhard Rahm (ULEI) – Institute of Computer Science, Faculty of Mathematics and Computer Science, Leipzig University
- Marco Herling (UKL) – Medical Clinic I – Clinic and Polyclinic for Haematology, Cell Therapy, Haemostaseology and Infectiology, Leipzig University Hospital
- BioThrust GmbH
- Cell.Copedia GmbH
- German Red Cross Blood Donation Service Baden-Württemberg-Hessen gGmbH
- ecSeq Bioinformatics GmbH
- Miltenyi Biotec B.V. & Co. KG
- ProBioGen AG
- QuoData GmbH
- Wacker Chemie AG (WACKER)
5. AlloMac
Development of a cost-effective allogeneic macrophage cell therapy against solid tumors
Macrophage cell therapy is an extremely attractive example of ‘living drugs’. The results from the first phase of SaxoCell and our laboratory results obtained in other projects suggest an application in cancer medicine in particular, as our preliminary experiments with mouse macrophages show that our genetically modified macrophages can destroy solid tumours in animal experiments. By transferring the same principle to human macrophages, we want to develop a cost-effective allogeneic macrophage cell therapy against solid tumours that will be available ‘off-the-shelf’.
Such a cell therapy will be significantly less expensive than competing treatment trials with autologous cells. In order to convince investors and regulatory authorities we need to carry out extensive and complex proof-of-concept experiments with human macrophages in mice as an essential part of preclinical development. To this end, we want to demonstrate the efficacy of allogeneic macrophage cell therapy with human macrophages in mouse xenograft models and investigate how transplanted macrophages interact with the recipient’s immune system. This will allow important conclusions to be drawn for optimal patient selection in future clinical trials.
Coordinator
- Michael H. Sieweke (TUD) – Dresden University of Technology
6. Edit-Save
New approaches in the treatment of blood, autoimmune and cancer diseases through safe and virus-independent genome editing
The overarching goal of the project is to further develop pioneering genome editing techniques in various therapeutic contexts using globally unique key technologies. As part of the ‘HemRecReady’ continuation project, the Buchholz lab and the DKMS Life Science Lab aim to develop a universal cure strategy for β-hemoglobinopathies by using recombinase technology to specifically induce the expression of γ-hemoglobin.
The work package of the Leipzig University and Fraunhofer IZI consortium is also developing an innovative and safe method of genome editing that does not require the use of viral vectors and nucleases. The focus here is on autoimmune diseases such as systemic lupus erythematosus (SLE) and systemic sclerosis (SSc), which are caused by B cells. In particular, the Sleeping Beauty transposon system is to be used for the genetic modification of macrophages in order to precisely introduce therapeutically useful genes and thus modify the pathological immune response. The Engeland laboratory intends to use this platform in a further work package to develop macrophages as carriers for oncolytic viruses in order to establish innovative strategies in cancer therapy and thus make a significant contribution to the overall vision of the joint project.
Coordinators
- Frank Buchholz (TUD) – Faculty of Medicine Carl Gustav Carus, TU Dresden
- Christine E. Engeland (ULEI) – Medical Clinic I – Clinic and Polyclinic for Haematology, Cell Therapy, Haemostaseology and Infectiology, Leipzig University Hospital, Leipzig University
Partners
- Zoltan Ivics (ULEI & IZI) – Clinical Immunology, Medical Faculty of the University of Leipzig & Fraunhofer Institute for Cell Therapy and Immunology (IZI)
- Christian Klemann (UKL) – Paediatric Immunology, Paediatric Rheumatology and Infectiology, Clinic and Polyclinic for Paediatrics and Adolescent Medicine, Leipzig University Hospital
- Maik Friedrich (ULEI) – Clinical Immunology, Faculty of Medicine, University of Leipzig
- Sandy Tretbar (IZI) – Department of Cell and Molecular Biology, Fraunhofer Institute for Cell Therapy and Immunology (IZI)
- DKMS Life Science Lab gGmbH
7. MSC-READY
Development of MSC-based drugs and their industrial, dataintegrated and AI-supported volume production in Germany
The overall goal of SaxoCell is the development of cell and gene therapeutics for the affordable, safe treatment of patients suffering from previously untreatable diseases. The production and clinical testing of these advanced therapy medicinal products (ATMPs) have been major challenges to date. Our active ingredient Desacell® is already undergoing clinical trials. This project therefore aims to:
- Develop cell-based drugs for various serious diseases, in particular with Desacell® for further testing
- Development of safe and cost-efficient production in Germany
- Development of the entire value chain, from production in Germany to clinical application in North America and Europe
- Replication of the clinical transfer process for other therapeutic developments and design of a GMP process for iPSC for the treatment of retinal degenerative diseases
- Abstraction of the technology transfer process for new service offerings.
The project leads to new products, processes and services with a considerable level of innovation. The co-operation enables cost-efficient results. It prepares for clinical approvals and industrial production.
Coordinators
- Mario Rüdiger (TUD) – Saxony Centre for Feto/Neonatal Health, Faculty of Medicine Dresden and University Hospital Carl Gustav Carus, TU Dresden
- Marius Ader (TUD) – Centre for Regenerative Therapies Dresden (CRTD), Faculty of Medicine Dresden, TU Dresden
Partners
- Thomas Neumuth & Erik Schreiber (ULEI) – ICCAS, Faculty of Medicine, Leipzig University
- Erhard Rahm & Jan Ewald (ULEI) – ScaDS.AI, Institute of Computer Science, Faculty of Mathematics and Computer Science, Leipzig University
- MDTB Cell Manufacturing GmbH
- DKMS Stem Cell Bank gGmbH
8. SaxoCellutions
SaxoCell provides solutions: Further development of the innovation hub as the central interface of the cluster
SaxoCell will establish an internationally visible lighthouse in the field of innovative cell and gene therapeutics in Saxony. The close cooperation between partners from research and industry and thus the targeted transfer of research results into application is a particularly important strategic element of our cluster. SaxoCellutions will offer research projects and partners the appropriate innovation-orientated support.
Proven elements from the existing SaxoCell Hub with its programmes (PAP, ICP, CMP) will be expanded to include a new programme, the Cluster Engagement Programme (CEP), and the integration of consulting services from the former adjacent platform technologies CLINICS and OMICS.
Programmes are to be expanded, particularly in the areas of education, financing and investor events and increased networking with relevant stakeholders (e.g. business development agencies). It remains the declared aim to create complementary offers to the existing ecosystem and to integrate existing structures.
Coordinators
- Dorit Teichmann (TUD) – TU Dresden
- Ilka Henze (IZI) – Fraunhofer Institute for Cell Therapy and Immunology (IZI)
- Stefanie Binder (ULEI) – Clinical Immunology, Faculty of Medicine, Leipzig University
Partner
- ecSeq Bioinformatics GmbH
Associated Partner
- Klinikum Chemnitz gGmbH