8:00am | Morning Registration & Networking

8:15 am Chairs Opening Comments

INVESTMENT & COMMERCIALISATION

8:25 am Medicen Initiative

Synopsis

Uncover the benefits of a unity community:
• Regrouping pharmaceutical companies, start-ups and academics in the microbiome field. Actively collecting and understanding the
current, in silico, in vitro and in vivo tools available today and recommend their best potential use
• Explaining the initiative’s aims also, on the basis of use cases in the pharmaceutical industry
• Explore the elaborate decision trees on what triggers microbiome studies today and also what is missing to be able to generate more
systematic microbiome data on future drug products

8:55 am Building Investor Confidence in Microbiome Drug Development; how to Promote And Restore Confidence

Synopsis

• Numerous challenges from bench to bedside but overall industry progress
• Selecting therapeutically-relevant indications beyond C. difficile
• The impact of recent clinical setbacks – Lessons learned on how and when to enter clinic with microbiome therapeutics

MICROBIOME BASED BIOMARKERS & DRUG RESPONSE

9:25 am Using Precision Microbiome Profiling to Develop a Biomarker for Immune Checkpoint Inhibitor Response and a Potent Therapeutic Consortium

Synopsis

  • Microbiotica’s metagenomic platform in combination with a new microbiome in Melanoma has enabled identification of a microbiome signature of response to Immune Checkpoint Inhibitor consistent across four independent studies
  • MB097 is a precision-medicine Live bacterial Therapeutic derived from a microbiome signature
  • Human primary immune cell assays and syngeneic models have validated
  • MB097 is being scaled up for First-in-human trials to start in 2022

9:55 am Discover how Biomarkers are Developing & Validating Therapeutic Targets

Synopsis

  • Biomarker; causality versus association in clinical sciences
  • Case report; Bif105 reduce pectic ulcers
  • Determining mode of action of live therapeutics

10:25 am Data Directed Discovery of Microbiome Derived Therapeutics

  • Lutz Kraus Head of Data-Mining and Artifical Intelligence, Microba

Synopsis

  • 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

10:55am | Morning Poster Session

TRACK A: MANUFACTURING MILESTONES & ADVICE

11:15 am Effectively Scaling Up Microbial Therapeutic Manufacturing

11:45 am Co-Cultivation is a Powerful Approach to Produce a Robust Functionally Designed Synthetic Consortium as a Live Biotherapeutic Product (LBP)

Synopsis

  • PharmaBiome have developed a co-culturing technology for the production of microbial consortia based on bottom-up functional design principles
  • Co-cultured consortia have improved stability and robustness properties compared to single strain cultures
  • Co-culturing strains increases the overall yield

12:15 pm Delve Into Manufacturing and Controls of LBPs: Meeting GMP and Regulator guidelines

Synopsis

  • Definition of LBPs by regulators ( FDA/EDQM)
  • Applicable Guidelines and Pharmacopea monographs for Mfg and Controls
  • Application : CQAs and QTPPs

12:45 pm Technology platforms for accelerating R&D of LBPs for the gastrointestinal tract

12:45 | Lunch & Structured Networking

TRACK B: DISEASE SPECIFIC CASE STUDIES

11:15 am A Deep Dive Into the Potential of Microbiome Therapeutics in Cardiometabolic And Related Disorders

Synopsis

Learn about:

  • FMT as unique discovery tool and potential intervention
  • The value of Microbiome Therapeutics in Diabetes, NAFLD/NASH and Cancer-related cachexia

11:45 am Harnessing the Microbiome for Drug Discovery: the Example of a Microbiome-Derived Therapeutic for Ulcerative Colitis

Synopsis

  • Microbiome-derived IL-10 inducer on specific bioassays
  • Characterization and preclinical validation of EB1010
  • Intended clinical development of EB1010 in Ulcerative Colitis

12:15 pm BGY-1601, Vaginal tablet: a “Universal” First-Line Monotherapy of Acute Vaginitis Symptoms

Synopsis

Learn how this applies to:

  • Women’s Health
  • Live Biotherapeutic Products
  • Bacterial Vaginosis (BV) and Vulvovaginal Candidiasis (VVC)

12:45 pm Choosing the right CDMO for your LBP Project

12:45 | Lunch & Structured Networking

1:45 pm A Novel Therapeutic Approach for the Elimination of Harmful Bacteria From the Microbiome

Synopsis

  • Learn the development of Eligobiotics(r): a new class of phage-derived antimicrobials with unparalleled specificity
  • EB003: an Eligobiotic(r) for the treatment of Shiga toxin-producing E.coli
  • Eligobiotics(r) as novel Gene Therapy products allowing precise intervention on the microbiome

2:15 pm Do’s and Don’ts’s of LBP Lyophilization

Synopsis

  • Challenges in LBP lyo manufacturing
  • Lyophilization scale up challenges
  • Importance of controlled drying process

2:45 pm Optimized Continuous Drying for Microbiome Applications

Synopsis

One of the main issues concerning the formulation of API is their loss in action after processing and
during storage. In fact, actives for applications on microbiome can be sensitive to temperature,
oxygen, moisture, pressure and pH

This talk will highlight:

  • Why the electrostatic spray drying is desired
  • How some methods can induce thermal stress, dehydration, shear stress, oxidative stress and how
    all of these may decrease the efficiency of active
    • Explain why electrostatic spray drying, working in continuous at a lower temperature than spray drier, was studied in different applications for microbiome, to evaluate advantages of this process

2:55 pm MRM Health’s Preclinical Optimized Consortia Programs in Metabolic Disease and CNS Disorders

Synopsis

  • Partnered programs with IFF in Type 2 Diabetes and NASH
  • Preclinical program in Parkinson’s Disease

3:25 | Afternoon Break & Structured Networking

1:45 pm MaaT013 – A Dysbiosis Correcting Live Biotherapeutic for the Treatment of Acute Graft-vs-host-Disease

Synopsis

  • Introduction to MaaT Pharma’s Microbiome Ecosystem Therapies platform
  • Discussion of recent results obtained in 76 patients with acute Graft-versus-Host Disease with MaaT013
  • Perspectives for microbiome ecosystem-based therapeutic approaches

2:15 pm Drug Development in the Skin Microbiome for the Treatment of Pruritus Associated with Atopic Dermatitis

Synopsis

  • Pre-Clinical Development and Immune Regulation
  • Mechanisms of Action – Live vs. Dead
  • Additional Targets

2:45 pm A non-invasive patented method to obtain unique inner-colonic microbiome

Synopsis

• Obtain unique inner-colonic microbiome
• In a proof-of-concept clinical trial, we collected stool and three HygiSampleSM from up
to 20 healthy patients and studied their microbiome community, including taxonomy,
phylogeny, and biological gene clusters (BGCs)
• Of all bacterial strains detected in our study, a third were unique to the HygiSample,
with a notable contribution from the different biogeographic locations. There was also a
clear gradient of bacterial communities along the colon, and the results were consistent
between sequencing and analysis methods
• Our patented HygiSample is currently the only non-invasive way of obtaining inner-colonic
microbiome information, and without the ill effects of oral prep purgatives.
• We will present the research goals and target indications we are currently pursuing

2:55 pm ECOSPOR III data

Synopsis

To highlight:

  • The efficacy and safety of SER-109 in patients with recurrent CDI
  • Efficacy of SER-109 versus placebo in patients with risk factors for recurrence
  • The time to recurrence and the importance of rapid microbiome recovery
  • Quality of life in patients receiving SER-109 compared to placebo
  • Inactivation of potential pathogens in donor stool via the manufacturing process

3:25 | Afternoon Break & Structured Networking

3:55 pm Taking the Microbiome Beyond the gut – Realizing the Full Potential of Microbiome Therapies Through Targeted Systemic Effects

Synopsis

  • After landmark successes in C. diff, the rapidly maturing microbiome field is poised to deliver meaningful clinical data across a wider
    range of systemic diseases
  • Principles for target- and mechanism-driven LBP discovery & development
  • Successful drug development is about more than just great research – CMC, IP, Clinical & Regulatory considerations

4:25 pm Inflammation, Iron And the gut Microbiome; Challenges for Mitigating the Effects of Inflammatory Bowel Disease Using LBPs

Synopsis

  • Learn how Ferryx has identified a safe and effective strain of Streptococcus thermophilus (FX856)
  • This is able to survive and thrive during periods of active inflammation and has demonstrated anti-inflammatory properties making it an ideal candidate for an LBP to ameliorate symptoms of IBD

REGULATORY CONSIDERATIONS & CHALLENGES

4:55 pm Equip and De-Risk Your Microbiome Drug Development for the European Market – Regulatory Science and a ‘Development-by- Design’ Approach

  • Celine Druart Pharmabiotic Research Institute, Microbiome Project Manager

Synopsis

  • Overview of the current European regulatory framework surrounding microbiome drug development
  • Microbiome drug products are Biologics – applying the Development-by-Design mindset and the added value of tools such as the TPP; QTPP and Risk Analysis
  • Potential future evolution of the European regulatory framework; ongoing revision of the Blood, Tissues & Cells legislation

5:25 pm Regulatory Considerations for Microbiome Based Therapeutics

Synopsis

  • Investigational New Drug Applications (INDs)
  • Additional Chemistry, Manufacturing and Controls (CMC) considerations for INDs with:
  1. Fecal Microbiota Transplantation (FMT)
  2. Live Biotherapeutic Products (LBPs)
  • COVID testing for FMT donors

End of Conference