Safe and scalable multi​​modal immunotherapy

Leveraging clonal immortalised MSC-derived extracellular vesicles

Science

Multimodal signalling approaches are the future of immunotherapy, ranging from autoimmunity to tissue repair. However, they have been hindered by various scientific and manufacturing challenges, such as lack of adequate quality control and batch-to-batch variability.

We have developed a safe and scalable immunotherapy by leveraging the multimodal action of ​high-performing extracellular vesicles (EVs). These EVs are derived from specific monoclonal mesenchymal stem/stromal cell (MSC) lines, which were previously immortalised to supply the full drug life cycle.

The scientific and translational efforts are built on over a decade of foundational work by Prof. Bernd Giebel at the University of Duisburg-Essen, a pioneer in the MSC-EV field.

Who we are

BERND GIEBEL PH.D.
FOUNDER AND CSO
  • Pioneered the MSC-EV field and has focused on the translation of M​SC-EV into clinical settings for over a decade
  • Authored over 100 peer-reviewed publications about EVs, including breakthrough MSC-EVs upstream and downstream processes as well as single-EV characterisation tools
  • Professor in Translational EV Research at the University of Duisburg-Essen (UDE)
  • Global co-chair of the International Society for Cell & Gene Therapy (ISCT) EV Committee
  • Received his Ph.D. in Neurogenesis at the University of Cologne 
Pierre Arsène
Founder and EXECUTIVE Chair
  • Serial biotech entrepreneur in the Extracellular Vesicle (EV) field
  • Accumulated a decade of experience in healthcare investment banking at J.P. Morgan
  • Closed over 20 transactions valued $70B
  • Contributed to multiple patents and publications in EV biomedical applications
  • Conducted postgraduate research in biophysics and nanoelectronics at the University of Cambridge (Cavendish Laboratory)
  • Received his Master of Science in Management from HEC Paris (Grande Ecole)  
JENS KURTH PH.D.
CE​​O
  • Seasoned biotech executive with nearly 30 years of experience in translating innovative therapies into development, regulation, and commercialisation globally across both biotech startups and large pharmaceutical companies
  • Co-founded several VC-funded biotech startups, securing over $90M in funding
  • Held significant tenures at Miltenyi, Novartis, and Baxter, leading global business operations and contributing to major advancements in biologics, gene and cell-based therapies, as well as immuno-oncology treatments
  • PhD and MSc in Biochemistry from the University of Cologne
DANIEL GAU PH.D.
DEVELOPMENT LEAD
  • Pre-clinical and CMC manufacturing specialist for EVs
  • Worked previously in various senior positions at Unicyte, Fresenius, Merck and TF Instruments
  • Received his Ph.D. in Molecular and Neurobiology at the University of Heidelberg
Dirk Hermann M.D.
Clinical Advisor
  • Professor in Vascular Neurology, Dementia and Age Research at the University of Duisburg-Essen
  • Focused on the promotion of tissue remodeling and neuroplasticity in the ischemic brain, including the involvement of EVs and their multimodal signalling
  • Authored over 300 peer-reviewed scientific publications
  • Received his M.D. from Justus Liebig University in Gießen
Nikolaos Bechrakis M.D.
Medical Advisor
  • Professor of Ophthalmology and Chairman of the Department of Ophthalmology at the Universitätsklinikum Essen
  • Focused on various aspects of ophthalmic conditions and treatments, including keratoplasty, ocular melanoma, and intraocular lymphoma
  • Authored over 300 peer-reviewed scientific publications
  • Received his M.D. from Universitätsklinikum Benjamin Franklin in Berlin
Lambros Kordelas M.D. PH.D
Clinical Advisor
  • Medical director of the DRK (German Red Cross) Blood Donation Service West and managing director of the stem cell donor database West German Donors Central (WSZE)
  • Research focused on haematology, oncology and allogeneic stem cell transplantation
  • Pioneer in the clinical use of MSC-EVs
  • Received his Ph.D. and M.D. from the University of Tübingen

Pipeline

We have an exciting pipeline of immune-related diseases with highly unmet clinical need

Ophthalmol​​ogy

Neurodegeneration

Autoimmune diseases

Publications

Dirk M Hermann, Luca Peruzzotti-Jametti, Bernd Giebel, Stefano Pluchino

Extracellular vesicles set the stage for brain plasticity and recovery by multimodal signalling

Brain, Volume 147, Issue 2, February 2024, Pages 372–389

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Labusek, N., Ghari, P., Mouloud, Y., Giebel B. et al. 

Hypothermia combined with extracellular vesicles from clonally expanded immortalized mesenchymal stromal cells improves neurodevelopmental impairment in neonatal hypoxic-ischemic brain injury

J Neuroinflammation 20, 280 (2023)

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Tertel T, Dittrich R, Arsène P, Jensen A and Giebel B

EV products obtained from iPSC-derived MSCs show batch-to-batch variations in their ability to modulate allogeneic immune responses in vitro

Front. Cell Dev. Biol., Sec. Stem Cell Research, Volume 11 – 2023

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Michel Bremer, Fabiola Nardi Bauer, Tobias Tertel, Robin Dittrich, Peter A. Horn, Verena Borger, Bernd Giebel

Qualification of a multidonor mixed lymphocyte reaction assay for the functional characterization of immunomodulatory extracellular vesicles

Cytotherapy 25 847-857

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Rabea J. Madel, Verena Borger, Robin Dittrich , Michel Bremer , Tobias Tertel , Nhi Ngo Thi Phuong , Hideo A. Baba4, Lambros Kordelas , Simon Staubach , Frank Stein, Per Haberkant, Matthias Hackl , Regina Grillari, Johannes Grillari , Jan Buer, Peter A. Horn, Astrid M. Westendorf, Sven Brandau, Carsten J. Kirschning, Bernd Giebel

Independent human mesenchymal stromal cell–derived extracellular vesicle preparations differentially attenuate symptoms in an advanced murine graft-versus-host disease model

Cytotherapy 25 821-836

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Robert Ossendorff, Sibylle Grad , Tobias Tertel , Dieter C Wirtz , Bernd Giebel , Verena Börger , Frank A Schildberg

Immunomodulatory potential of mesenchymal stromal cell-derived extracellular vesicles in chondrocyte inflammation

Front Immunol. 2023 Jul 26:14:1198198 

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Labusek, N., Mouloud, Y., Köster, C., Bernd Giebel et al.

Extracellular vesicles from immortalized mesenchymal stromal cells protect against neonatal hypoxic-ischemic brain injury

Inflamm Regener 43, 24

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Fabiola Nardi Bauer , Tobias Tertel , Oumaima Stambouli, Chen Wang , Robin Dittrich, Simon Staubach, Verena Borger , Dirk M. Hermann , Sven Brandau, Bernd Giebel

CD73 activity of mesenchymal stromal cell-derived extracellular vesicle preparations is detergent-resistant and does not correlate with immunomodulatory capabilities

Cytotherapy 25 138-147

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Tobias Tertel, Melanie Schoppet, Oumaima Stambouli , Ali Al-Jipouri, Patrick F. James, Bernd Giebel

Imaging flow cytometry challenges the usefulness of classically used extracellular vesicle labeling dyes and qualifies the novel dye Exoria for the labeling of mesenchymal stromal cell–extracellular vesicle preparations

Cytotherapy 24 619-628

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