Online Agenda
* All times shown in EST
8:30 am
8:30am | Virtual Coffee Morning
8:55 | Chair’s Opening Remarks
9:00 am Keynote: Systemic Anti-inflammatory Therapy with Orally- Delivered Bacterial EVs
Synopsis
- The small intestinal axis (SINTAXTM) is a network of functional and anatomical connections between the gut and the rest of the body
- Naturally shed EVs from selected single-strains of bacteria isolated from human gut mucosal commensal can engage Sintax with striking anti-inflammatory effects
- These candidate medicines have a unique pharmacological profile:
orally-delivered and gut-restricted with systemic effects
9:30 am Exosome-based Intracellular Delivery of Therapeutic Proteins
Synopsis
- How to load therapeutic proteins in exosomes
- Identifying appropriate therapeutic candidates
- Validating in vivo therapeutic efficacy using Cre-lox system
9:55 am From ‘Willow Bark Extract’ 2.0 to Precise Therapeutic Modality, Delivering Biologicals to Exosomes
Synopsis
- Strategies for delivery of therapeutic proteins into exosomes
- In or out, topology question in protein targeting and physiological effects
- Choice of cell type on protein targeting and therapeutical effectiveness
10:20 am Live Presenter Q&A
Synopsis
- Ask the speakers your most burning questions!
10:30 am GMP Manufacturing for Exosome-based Therapies
Synopsis
• The critical role of analytics and process design for clinical production
and scale-up
• Manufacturing of exosomes, challenges and opportunities
• Establish an effective process for clinical manufacturing and beyond
11:00am | Scientific Poster Session
11:30 am Biological Treatment for Spinal Cord Injury – From Complete Cut to Functional Recovery
Synopsis
- Introduction to the science behind the company’s product
- Intranasal delivery – a new approach for SCI
- NurExone Biologic as exosome-based drug delivery platform for other indications
11:55 am Developing ARRDC1-Mediated Microvesicles (ARMMs) as Drug Delivery Vehicles
Synopsis
- Highlight production, purification processes at Vesigen
- Characterization of ARMMs
- Examples of cellular uptake and functional delivery of ARMMs
12:20 pm Live Presenter Q&A
Synopsis
- Ask the speakers your most burning questions!
12:30 pm Strategies for Maximizing MSC-EV Productivity for Therapeutic Product Development and Clinical Translation
Synopsis
• Key challenges exist for next-generation EV product development &
clinical translation, especially pertaining to lot size & scale
• Starting in right-fit scalable platforms simplify generating significant
parent cell volumes
• Maximizing EV production productivity from hMSC cultures in scalable
platforms
12:40 pm Virtual Speed Networking
Synopsis
Grab a coffee from the comfort of your own kitchen and jump into
this 1:1 networking session to make new connections, exchange virtual
business cards and maybe even see a friendly face or two!
1:15pm | Networking Lunch
Progressing the Clinical Landscape of Exosome Therapeutics
2:00 pm A Phase 2 Study of Exo-CD24 for COVID-19
Synopsis
- Delivery of CD24 by exosomes
- Pathophysiology of COVID -19 and role of exo-CD24
- Clinical trial results
2:25 pm Investigating the Therapeutic Potential of Perinatal-Derived Extracellular Vesicles for Musculoskeletal Disease
Synopsis
- Pre-clinical work with perinatal-derived extracellular vesicles
- Anti-inflammatory mechanisms
- Potential of extracellular vesicles for osteoarthritis
2:50 pm Live Presenter Q&A
Synopsis
- Ask the speakers your most burning questions!
3:05pm | Afternoon Break
3:30 pm Insights from the Development & Clinical Translation of Engineered Exosome Therapeutics
Synopsis
- Codiak has developed a proprietary exosome engineering platform to generate, characterize, and produce engineered exosomes at industrial scale
- Codiak’s two clinical programs, exoSTING™ and exoIL-12™ are currently in early-stage clinical studies for immuno-oncology. The IND filing for a third clinical program, exoASO-STAT6™, is planned by the end of 2021
- The discovery, engineering, translation, and clinical entry of these three programs will be discussed, including regulatory implications and lessons learned related to manufacturing
Overcoming Regulatory Hurdles to Advance Towards the First Clinically Approved Therapy
3:55 pm Regulatory Landscape for Exosomes
Synopsis
- Chemistry manufacturing and control of exosomes
- Pre-clinical regulatory strategy for exosomes
- Navigating the FDA regulatory requirements for exosomes under CBER
4:20 pm Live Presenter Q&A
Synopsis
- Ask the speakers your most burning questions!