AGENDA
10-11 October 2023 | Cambridge, UK
TUESDAY 10TH OCTOBER, 2023
08:00: Registration, welcome refreshments and networking
Biomarkers, Diagnostics and Liquid Biopsies
09:00 - OPENING REMARKS
Chair: Costanza Emanueli, Professor, Chair in Cardiovascular Science, Imperial College London, UK
09:05 - PRESENTATION
Extracellular Vesicles in Injury Mediate Inflammatory Signalling
- Akbar Lab’s focus: Study of endothelial cell derived extracellular vesicles (EV) in Cardiovascular and metabolic disease
- Research findings: Endothelial cell EV enriched in blood post heart attack, linked to myocardial injury extent in patients
- Function of EV: EV carry endothelial cell markers, trigger splenic-neutrophil and splenic-monocyte mobilization, and contain RNAs that prime immune system for inflammation after heart injury
Naveed Akbar, Associate Professor of Cardiovascular Science, University of Oxford, UK
09:25 - PRESENTATION
Plasma Extracellular Vesicle-Associated microRNAs for On-treatment Response Assessment
- Multiple Myeloma cells release EVs into circulation
- IsoSeek detects >20.000 miRNA variants in plasma EVs
- Plasma EV-miRNA distinguish MM samples from controls
- Plasma EV-miRNA variant signatures predict response to treatment
Michiel Pegtel, Department of Pathology, Head Exosomes Research Group, Director Liquid Biopsy Center, Cancer Center Amsterdam
09:45 - PRESENTATION
Extracellular Vesicles as Innovative Biomarker in Infectious Coagulopathies
- Severe bacterial and viral infections are associated with a risk of coagulopathies that contributes to a poor prognosis for the patient
- Extracellular vesicles (EV) participate in the regulation of thrombo-inflammatory mechanisms in infectious coagulopathies
- Their contribution to hemostasis is not exclusively procoagulant but depends on a balance between their procoagulant and fibrinolytic activities
- Fibrinolytic EV of granulocyte origin are protective in patients with severe sepsis, whereas procoagulant EV carrying tissue factor are predictive of severity and the occurrence of thrombosis in COVID-19 patients
- A better understanding of the role of EV opens the way to new biomarkers for a more personalized medicine in the management of infectious coagulopathies
Romaric Lacroix Professor, C2VN, Aix-Marseille University, France
10:05 - PANEL DISCUSSION
How Can EV Assays Reach Clinical Practice?
- What are the current limitations for EV assays to reach clinical practice?
- What are the most promising clinical applications of EV as biomarkers in the cardiovascular field?
- How to standardize an EV assay?
Moderator: Costanza Emanueli, Professor, Chair in Cardiovascular Science, Imperial College London, UK
Naveed Akbar, Associate Professor of Cardiovascular Science, University of Oxford, UK
Michiel Pegtel, Department of Pathology, Head Exosomes Research Group, Director Liquid Biopsy Center, Cancer Center Amsterdam
Romaric Lacroix, Professor, C2VN, Aix-Marseille University, France
10:45 - NETWORKING COFFEE BREAK, POSTER VIEWING
Plenary Session: EV R&D, from Bench to Bedside
11:15 - OPENING REMARKS
Chair: Duncan Ross, CEO, Founder, Kimera Labs, USA
11:20 - PLENARY PRESENTATION
The NIH Extracellular RNA Communication Program: Secreted RNA for Diagnosis and Therapeutics
- Overview of the NIH Extracellular RNA Communication Program
- exRNA Tools and Resources (www.exRNA.org)
- EV-based technologies as COVID-19 diagnostics and use of EVs as COVID-19 biomarkers: RADx-rad Exosome-based Non-traditional Technologies Towards Multi-Parametric and Integrated Approaches for SARS-CoV-2
- EV-based therapeutics in regenerative medicine
Christine Happel, Program Officer, Extracellular RNA Communication program, NCATS, National Institutes of Health, USA
11:40 - PLENARY PRESENTATION
Milk extracellular vesicles as model nanoparticles for oral delivery of nucleic acids
- Milk extracellular vesicles (mEVs) resist gastrointestinal digestion
- mEVs permeate the intestinal epithelium in vitro, including intestinal epithelial organoids
- mEVs can be loaded with nucleic acids in multiple ways
- Nucleic acid-loaded mEVs demonstrate therapeutic activity against inflammatory bowel disease in vitro and in vivo
Driton Vllasaliu, Senior Lecturer in Pharmaceutics, King’s College London, UK
12:00 - kEYNOTE PRESENTATION
Translating Science from Bench to Bedside – A Case for Extracellular Vesicles
- Over the last 15 years, Extracellular Vesicles (EVs) have emerged as pivotal components in both intra- and inter-cellular communication, influencing normal physiological processes and contributing to pathological conditions
- Of paramount importance in harnessing the clinical applications of extracellular vesicles is their inherent capacity to encapsulate information about their cellular origin and the specific messages they intend to convey to target cells
- Specifically, I will briefly explore into their potential utility as disease biomarkers, their suitability as intervention targets, enabling us to modulate physiological functions by inhibiting their release or restricting their access to tissues, thus influencing disease outcomes
Carlos Salomon, Associate Professor, Head, Translational Extracellular Vesicles in Obstetrics and Gynae-Oncology Group, The University of Queensland, Australia
12:30 - PLENARY PANEL DISCUSSION
What Are the Major Translational Bottlenecks for EV-Based Therapeutics?
- How can EVs be utilized for therapeutic purposes?
- Direct EV therapies (off-the-shelf) vs. personalized EV therapeutics?
- How can EVs be harnessed for targeted drug delivery?
- What are the pros/cons of using purified stem cell derived EVs as therapeutics in the area of regenerative medicine vs. the whole secretome?
- How can microphysiological systems (tissue chips) provide a model to further understand EV-mediated signaling and therapeutic activity?
MODERATOR: Duncan Ross, CEO, Founder, Kimera Labs, USA
Christine Happel, Program Officer, Extracellular RNA Communication program, NCATS, National Institutes of Health, USA
Carlos Salomon, Associate Professor, Head, Translational Extracellular Vesicles in Obstetrics and Gynae-Oncology Group, The University of Queensland, Australia
Driton Vllasaliu, Senior Lecturer in Pharmaceutics, King’s College London, UK
13:00 - NETWORKING LUNCH, POSTER VIEWING
Exosome Based Therapies and Regenerative Medicine
14:30 - OPENING REMARKS
Chair: Driton Vllasaliu, Senior Lecturer in Pharmaceutics, King’s College London, UK
14:35 - PRESENTATION
Unlocking the Potential of Exosome-Based Therapy for Spinal Cord Injury
- Extracellular vesicles as a game changer therapy for spinal cord injury and other traumatic CNS Indications
- Key challenges in the translation of extracellular vesicles loaded with PTEN-siRNA (ExoPTEN)
- NurExone Biologic as a hybrid company with a strong technology platform to address global challenges in the field:
- Loading efficiency of EVs with siRNA
- Large scale production of EVS with a new 3D bioprocess concept
Lior Shaltiel, CEO, NurExone Biologic, Israel
14:55 - PRESENTATION
History Theory Physics and Future of Exosome Technologies in Clinical Science and Medicine
- Heterogeneity in extracellular vesicle populations
- Discussions of biodistribution of EVs for clinical translation
- Potential for rapid evaluation of EVs for clinical release
- RNA species as contents of msc EV populations
- Regulatory requirements for FDA sanctioned EV trials
Duncan Ross, CEO, Founder, Kimera Labs, USA
15:15 - PRESENTATION
Embryonic Stem Cell-Derived EVs in Cardiac Remodelling
Small extracellular vesicles (sEV) from various cell sources have been demonstrated to enhance cardiac function in preclinical models by repairing damaged myocardium after myocardial infarction
We present a comprehensive comparison of some of the multiple effects that sEV from different cell sources can have in cardiac repair
We see that sEV from embryonic stem cells attenuate cardiac remodeling following ischemia reperfusion injury in mice through superior pro-angiogenic and anti-fibrotic effects
Hernán González-King Garibotti, Senior Research Scientist, AstraZeneca, Sweden
15:35 - PANEL DISCUSSION
What are the essential components that need to be in place to introduce EV-based treatments into clinical practice?
- What factors are currently absent in promoting the involvement of pharmaceutical companies in treatments based on EVs?
- Do we possess a high level of certainty in distinguishing effects attributed to EV from those caused by co-isolated molecules?
- Are these effects both reproducible and physiologically significant enough to justify advancement into clinical applications
- What one step will solve the historic clinical and regulatory hurdles for the success development of extracellular vesicles?
MODERATOR: Driton Vllasaliu, Senior Lecturer in Pharmaceutics, King’s College London, UK
Lior Shaltiel, CEO, NurExone Biologic, Israel
Duncan Ross, CEO, Founder, Kimera Labs, USA
Hernán González-King Garibotti, Senior Research Scientist, AstraZeneca, Sweden
16:15 - SHORT REFRESHMENT BREAK
16:30 - BREAKOUT DISCUSSIONS
17:30 - SPEED NETWORKING AND DRINKS RECEPTION
19:30 - CLOSE OF DAY ONE
26-27 June 2023 | Stockholm
WEDNESDAY 11TH OCTOBER, 2023
08:30: Welcome refreshments and networking
Engineering, Production and Scale Up
09:00 - OPENING REMARKS
09:05 - PRESENTATION
Chair: Brittany Mihelich, Principal Scientist, Extracellular Vesicles, Astellas Institute for Regenerative Medicine, USA
Bioengineered Exosomes Deliver Multiple Antigenic Fragments and Drive a Broad Vaccine Response
- Engineered exosomes are able to co-deliver multiple antigenic fragments
- Exosomes are acquired by antigen-presenting cells and their antigens loaded to MHC Class II molecules
- This platform provides a fast and adaptable method to test vaccine candidates
James Edgar, Sir Henry Dale Fellow, Group Leader, Department of Pathology, University Of Cambridge, UK
09:25 - PRESENTATION
EV Production, Scalability and Automation
- Regulatory vs business requirements for development of the EVs production platform
- Presentation of the EXO Biologics’ EVs production platform used in the EVENEW Clinical Trial in Broncho Pulmonary Dysplasia
- Challenges in automation of the EVs production process – in-process quality control
Marcin Jurga, CSO, EXO Biologics SA, Belgium
09:45 - PRESENTATION
Stem Cell EVs on the Road to the Clinic
- Industrializable platform for EV manufacturing
- Upstream process of EV manufacturing determines composition and function
- Characterization and preclinical use of iMSC derived EVs in dry eye disease
Jens Gruber, CSO, Curexsys GmbH, Germany
10:05 - PANEL DISCUSSION
Engineering, Production and Scale Up
- Changes during any point of production can alter EV yields and function. How have you approached moving from smaller, research scale activities to larger scale manufacturing? Have you experienced any major challenges along the way?
- How have you approached developing quality control measures during production?
- Do you rely on multiple factors of quality and have you tied these specific components, proteins or RNAs for example, to function?
- Potency tests are important for quality control and defining mode of action. They may also be required for regulatory acceptance. How have you approached developing potency tests? Are they tied to your specific indication(s) of interest?
- There are many different approaches to therapeutic EV production across our industry. Do you think we need to standardize our processes for broader regulatory acceptance?
MODERATOR: Brittany Mihelich, Principal Scientist, Extracellular Vesicles, Astellas Institute for Regenerative Medicine, USA
Marcin Jurga, CSO, EXO Biologics SA, Belgium
Jens Gruber, CSO, Curexsys GmbH, Germany
James Edgar, Sir Henry Dale Fellow, Group Leader, Department of Pathology, University Of Cambridge, UK
10:45 - NETWORKING COFFEE BREAK, POSTER VIEWING
Plenary Session: Isolation, Characterisation, Cargo Analysis and Function of EVs
11:15 - OPENING REMARKS
Chair: Pascale Zimmermann, Professor, KU Leuven, Belgium, and Cancer Research Center Marseille, France
11:20 - PLENARY PRESENTATION
Novel EV Cargo and Control of Innate Immune Responses
- EV represent an enzymatically active metabolic compartment = ‘Active EV’
- Active composition will define the functional significance of EV in control of inflammation
- This presents the opportunity to tune ‘active EV’ (natural or synthetic) to complement specific therapeutic needs for control of inflammation and regeneration and to meet specific challenges e.g. reduced repair responses in ageing
Andrew Devitt, CTO of EVolution Therapeutics and Professor, Head of Biosciences, Aston University, UK
11:40 - KEYNOTE PRESENTATION
Biology and Function of EVs in Cancer
- The basic and applied biology of extracellular vesicles (EV)/exosomes will be discussed
- Biodistribution and trafficking of EV/exosomes will be highlighted
- Therapeutic applications of EVs/Exosomes in tissue regeneration and cancer will showcased
Raghu Kalluri, Professor, Chair Department of Cancer Biology, MD Anderson Cancer Center, USA
12:10 - PLENARY PRESENTATION
Advanced Molecular Tools for Sensitive Detection and Characterization of Extracellular Vesicles
- How to increase the assay specificity for detection of EVs
- How to combine flow cytometry technology with molecular tools for sensitive and specific detection of EVs
- How to address the heterogeneity of EVs in biological samples
Masood Kamali-Moghaddam, Professor of Molecular Diagnostics, Dept. of Immunology, Genetics and Pathology, Uppsala University, Sweden
12:30 - PLENARY PANEL DISCUSSION
Isolation, Characterisation, Cargo Analysis and Function of EVs
- What makes a reliable and useful EV biomarker?
- EV therapeutics: what are the future directions and tough questions that remain
- What are the specific functions of apoptotic bodies
- Moving targets, what are the impact of EV dynamics on EV studies?
MODERATOR: Pascale Zimmermann, Professor, KU Leuven, Belgium, and Cancer Research Center Marseille, France
Andrew Devitt, CTO of EVolution Therapeutics and Professor, Head of Biosciences, Aston University, UK
Raghu Kalluri, Professor, Chair Department of Cancer Biology, MD Anderson Cancer Center, USA
Masood Kamali-Moghaddam, Professor of Molecular Diagnostics, Dept. of Immunology, Genetics and Pathology, Uppsala University, Sweden
13:00 - NETWORKING LUNCH, POSTER VIEWING
Targeted Therapeutic Delivery with EVs
14:00 - OPENING REMARKS
14:05 - PRESENTATION
Harnessing Therapeutic Potential of Stem Cell Derived Extracellular Vesicles for Ischemic Stroke and Beyond
- Astellas Institute for Regenerative Medicine has built an early-stage platform for the production and characterization of extracellular vesicles (EVs)
- Reliable efficacy is observed with Astellas’ EVs in a rat model of ischemic stroke and demonstrate complex functional activity in vitro
- Our vision is to apply this platform to address clinical needs across a range of indications
Brittany Mihelich, Principal Scientist, Extracellular Vesicles, Astellas Institute for Regenerative Medicine, USA
14:25 - PRESENTATION
Engineered EVs for Biotherapeutics Delivery
- Identifying novel strategies for bio-engineering EVs
- Engineered EVs for efficient delivery of protein biotherapeutics to the CNS (including genome editors)
- In situ bio engineering of body’s own EVs for extrahepatic delivery
Dhanu Gupta, Postdoctoral Researcher, Department of Paediatrics, University of Oxford
14:45 - PRESENTATION
Hyaluronan-Coated EVs in Health and Disease
- Hyaluronan (HA) is a non-immunogenic and biocompatible polysaccharide that has gained a lot of interest in the medical applications and drug delivery
- We have found that cells with active HA synthesis secrete HA-coated EVs
- We can produce HA-coated EVs by genetically manipulated cells
- HA enhances the specific targeting and safety of EVs, improving the potential of EVs as therapeutic tools and vehicles for drug delivery
Kirsi Rilla, Group Leader, University of Eastern Finland, Finland
15:05 - PRESENTATION
Extracellular Vesicles Engineering for Therapeutic Applications
- Display of various targeting ligands on the EV surface for specific target recognition
- Engineering EVs to improve protein cargo loading
- Protein delivery via EVs and endosomal escape
- In vivo safety profile of the designed EVs
Alena Ivanova, Postdoctoral Researcher, AstraZeneca, Sweden
15:25 - PANEL DISCUSSION
What is the main bottleneck for targeted EV delivery?
- How are EVs as a drug carriers compared to other synthetic non-viral and viral vectors?
- How to overcome endosomal entrapment of EVs?
- How to achieve extrahepatic delivery of EVs in vivo
- Engineering candidate screening can be a challenge with EVs. What is the best way to identify engineering candidates for EV modification in a specific indication? Are there in silico options?
- Final EV cell source, indication, and route of administration should be kept in mind during engineering experimental design. How to choose which cell type is best target for directed uptake for any given indication?
MODERATOR:
Brittany Mihelich, Principal Scientist, Extracellular Vesicles, Astellas Institute for Regenerative Medicine, USA
Dhanu Gupta, Postdoctoral Researcher, Department of Paediatrics, University of Oxford
Kirsi Rilla, Group Leader, University of Eastern Finland, Finland
Alena Ivanova, Postdoctoral Researcher, AstraZeneca, Sweden
15:45 - CLOSE OF FORUM
If have any questions about the agenda or speaking opportunities, then please email
Sponsorship Opportunities
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