8:30 am Virtual Registration & Networking
Morning Plenary – Microbiome Leaders Industry Review
9:00 am European Microbiome Leaders Panel Discussion
Synopsis
• What are the current strategies to take microbiome-based therapeutics to market?
• What role will partnerships play in future therapeutic strategies?
• What can public institutions and regulators to do to support the microbiome sector?
• What tools can be utilised to reveal causation and molecular mechanism of microbiome-based therapeutics?
• Given the status of the microbiome, where do you see the industry developing in five years?
10:00 am Gut Microbiome Endgame: Ramping up cGMP Program Design to Ensure Regulatory Preparedness for Microbiome Products
Synopsis
• Implementing program design approaches in order to ensure regulatory approval for IND filings
• Evaluation of successful clean room commissioning, release testing characterisation and stability testing approaches
• Providing an in-depth evaluation of the expertise required in order to successfully bring a microbiome-based product into the next phase
of a program’s lifescycle
10:30 am Shotgun Sequencing & Strain-Level Analysis: Study Design for Pre-Clinical & Clinical Development
Synopsis
• Study design considerations for safety and efficacy studies
• Standards, controls and compliance for clinical studies
• QC of Live Microbial Products (LBPs, FMT and Probiotics)
11:00 am Morning Refreshments and Speed Networking
Stream A: Discovery & Pre-Clinical Development of Microbiome-Based Therapeutics
Complexities of Discovering Novel Live Biotherapeutics
As the predominant microbiome-targeting drug modality, LBPs have the promise of providing the same efficacy as FMTs but with more characterised mechanisms and safety profiles. This theme will continue to put the spotlight on LBP case studies that impact gut microbiome composition and reverse disease phenotypes whilst also providing new insights to the challenges of developing these drug products.
Stream B: Clinical Development & Manufacturing of Microbiome-Based Therapeutics
Clinical Trial Design & Evaluating PK/PD
Given the heterogeneity of gut microbiome signatures from person to person, research questions in translational microbiome studies have become substantially more complex than their counterparts in basic science. This theme will provide insight into the key study design considerations when developing a microbiome-based therapeutic to help inform and progress through early and late-phase clinical trials.
12:00 MRM Health – the Next Level in Optimized Consortia Development
Sam Possemiers, CEO, MRM Health
12:00 Harnessing the Potential of the Keystone Bacteria Christensenella into Ground- Breaking Live Biotherapeutic Products
• Substantial efficacy on obesity and associated metabolic disorders demonstrated
in preclinical models
• Design of Phase 1 clinical trial
• Towards other major chronic target diseases
Georges Rawadi, CEO, LNC Therapeutics
12:30 From Computational Predictions to Preclinical Performance
• Reporting new positive pre-clinical results with Biomica’s rationally-designed consortia in our immune-oncology program
• Initiating a new program on Biomica’s pipeline- utilizing functional microbiome analysis for targeting abdominal hypersensitivity in IBS
Shiri Meshner, VP R&D, Biomica
12:30 Outlining Enterome’s Onco-Mimics Program: Microbiome-Derived Immunotherapy for Treatment of Cancers
• Clarifying how targeting novel antigens called oncomimics can induce cytotoxic T-cell response against tumors in combination with checkpoint inhibitors
• Understanding how EO2401 can be used in patients with Glioblastoma Multiforme (GBM)
Gregoire Chevalier, Scientific Affairs Manager, Enterome
13:00 Delivery, Survival, Engraftment & Activity of LBPs in the GI Tract
• Sharing how validated in-vitro technology platforms are a key tool for the preclinical work in LBPs development
• Exploring how the SHIME system enables integrated simulation of the full GI track, including lumen, mucosa and host
• Investigating the MoAs of LBPs in areas of the gut, which are not easily accessible, generating data complementary to in vivo studies
Aurelien Baudot, Head of Business Development, ProDigest
13:00 MicroRx Single Strain Live-Biotherapeutics: POC Clinical Data and Future Considerations
- From preclinical models to proof of concept in patients
- Next phase of clinical development
- Second generation MicroRx LBPs and new target diseases
Dr. Imke Mulder, Research Director, 4D Pharma
13:15 Lunch and Networking
13:30 Lunch and Networking
Microbiome Chemistry Small Molecules
Clinical Learnings of Live Biotherapeutics
Many researchers are identifying microbial by-products that modulate host function and have therapeutic efficacy. Due to the unknown regulatory and manufacturing requirements for Live Biotherapeutics, researchers are keen to explore microbiome-targeting small molecules due to their close alignment to traditional pharmacology. The purpose of this theme will be to review the potential of microbiome-targeted therapeutics derived from chemistry, not live organisms.
As microbiome researchers prepare for the first FDA-approved therapeutic, there are several significant learnings from ongoing clinical trials that can be leveraged to support the next generation of microbiome-based therapeutics. This theme will aim to provide new insight into the learnings and outcomes of the most high-profile clinical trials in industry.
14:30 Introducing Exeliom Biosciences
• Exeliom Biosciences was founded as a lean organization by a pioneer team in the field of translational microbiome research
• Exeliom Biosciences aims at bringing microbiome to the traditional pharma by developing a microbial therapy based on a single strain of Faecalibacterium prausnitzii
• "Human discovery first" is Exeliom Biosciences' guiding principle
Mathilde Antoine, Operations Manager, Exeliom Biosciences
15:00 A Novel Approach to Prebiotic Based Therapeutics
• Prebiotics as a co-intervention
• The potential SCFA’s to impact therapeutic efficacy
• The importance of gut health diagnostics in the development and personalisation
Kristofer Cook, CEO & Co-Founder, Carbiotix
15:30 Developing Microbiome-derived Molecules for the Treatment of Neurodegeneration
• Stellate Therapeutics’ microbiome-derived medicine platform spans discovery and screening to production and biomarker identification and has generated a portfolio of characterized drug candidates
• STL-101 is a potential first-in-class small molecule for the treatment of Parkinson’s and Alzheimer’s disease that acts through neuroprotection
• Microbiome-molecules are an ideal source for potential new treatments because they are endogenous and therefore less likely to be toxic and are also potential biomarkers to stratify patients for trials
Nicole McKnight, CEO, Stellate Therapeutics
16:00 Afternoon Break & Virtual Networking
14:30 Prevention of Recurrent Clostridium Difficile Following Treatment with Microbiota based Therapy: Clinical Results and Considerations
• Demonstrating how RBX2660 was efficacious for the prevention of rCDI with longterm durability at 6 months post-treatment
• Evaluating consistency with other ongoing clinical studies
• Exploring clinical trial design and considerations when working with LBP products
Ken Blount, CSO, Rebiotix
15:00 A Human-First Discovery Approach: Leveraging Clinical Data to Identify Microbial Communities Driving Positive Clinical Outcomes
• Utilizing data from human microbiota transplantation studies and machine learning to develop novel microbiome therapeutics and retire risk early
• Applying a Human-First Discovery approach to the development of microbiome therapeutics for a diverse range of conditions, such as inflammatory bowel disease and autism spectrum disorder
Zain Kassam, CMO, Finch Therapeutics
15:30 C difficile Infection and Microbiome Therapeutics: The Importance of Understanding Your Disease Target
• Highlight the importance of diagnostic assay selection in a subjective disease
• Review potential confounders in study trial design that may impact outcomes
• Highlight how a thorough understanding of the natural history of disease may impact selection of microbiome endpoints
Matt Henn, CSO, Seres Therapeutics
16:00 Data Directed Discovery of Microbiome Derived Therapeutics
• Presenting how big data in combination with machine learning can be applied for the rational discovery of microbiome-derived therapeutics
• Applying this novel approach to IBD which has helped identify new biological leads which have shown to supress key inflammatory pathways
• Developing new therapeutic leads for other indications, including metabolic diseases, GI conditions and psychiatric disorders
Lutz Kraus, Head of Data-Mining and Artificial Intelligence, Microba
16:10 Afternoon Break & Virtual Networking
4:30 pm Magnifying the Human Gut Microbiome
Synopsis
• Background to EBI’s 5000+ species collection of metagenome-assembled genomes (MAGs) for the human gut, the largest of its kind globally
• Understand the resources available for you to use
• Contextualise your isolate genomes against this human catalogue
5:00 pm Collaboration Roundtable Discussions
Synopsis
• We know that therapeutic insights from the human microbiome require successful collaborations across basic science, clinical expertise, and industry partners. With that in mind, this unique collaborative format will look to provide disease specific knowledge as it relates to the development of microbiome-based therapeutics and help further identify new solutions.
Roundtable A: IBD and the Human Microbiome
Roundtable B: Metabolic Disease and the Human Microbiome
Roundtable C: Cancer and the Human Microbiome
Roundtable D: Neurodegenerative Disease and the Human Microbiome
Roundtable E: Women’s Health and the Human Microbiome