Conference Day 2

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MICROBIOME REGULATION & DRUG DISCOVERY CONSIDERATIONS

8:20 am Chair’s Opening Comments

  • Julie Schwedock Associate Director Microbial Development Team, Takeda Biotechnologies

8:30 am Microbiome Profiling Tools for the Development of Clinical

Synopsis

• Curated databases for improved understanding of preclinical animal model studies
• Metatranscriptomics profiling provides an in-depth understanding of the composition and activity of the microbial community
• Bioinformatic tools and advanced analytics for human gut microbiome profiling

9:00 am PANEL DISCUSSION: Legislative & Regulatory Overview of the Microbiome Arena in the United States

9:30 am Discussing the Role of CDMO’s in the LBP Industry

10:00 am Introduction to NTCD-M3

Synopsis

• Highly statistically significant results in Phase 2 sets it apart from competitors
• NTCD-M3 is a single strain so facilitates manufacture and low cost of goods
• Being prepared for Phase 3
• Expected market positioning
• Introduction to SPOR-COV
• What it is and development plans

10:30 am Vedanta’s Live Biotherapeutic Product Development in the Clinic: VE303 & Beyond

  • Greg Medlock Director, Research, Vedanta Biosciences, Inc.

11:00 am Morning Break, Refreshments & Structured Speed Networking

TRACK A:
EMERGING TECHNOLOGY & UNCONVENTIONAL APPROACHES

12:00 pm Genetically Engineered Microbial Medicines (GEMMs) for the Treatment of Chronic Diseases

Synopsis

  • Novome has developed a suite of synthetic biology tools for engineering highly abundant gut commensal microbes
  • Establishing an exclusive niche through rare carbohydrate utilization enables robust and controllable engraftment of GEMMs in the gastrointestina l tract
  • The company’s lead asset is a GEMM designed to treat hyperoxaluria and prevent recurrent kidney stone formation through the breakdown of dietary oxalate
  • A recently completed first-in-human study in healthy volunteers demonstrated safety and tolerability of the therapy as well as platform proof-of-concept that strain engraftment can be precisely controlled by once-daily oral dosing of a prebiotic control molecule

12:30 pm Data-Driven Discovery of Microbiome Based Therapeutics

  • Trent Munro Senior Vice President of Therapeutics, 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 suppress key inflammatory pathways
  • Developing new therapeutic leads for other indications, including metabolic diseases, GI conditions and psychiatric disorders

1:00 pm Phage Therapies Targeting Pathogenic Bacteria in Chronic Indications

Synopsis

  • BOLT – a novel phage discovery platform allowing clinical data within 12-18 months
  • Cystic fibrosis – A phase 1b/2a study of BX004 targeting P. Aeruginosa
  • Atopic dermatitis – BX005, a topical phage cocktail targeting S. Aureus

TRACK B:
CLINICAL TRANSLATION, PATIENT STRATIFICATION & BIOMARKERS

12:00 pm PANEL: Learn How to Advance Your Clinical Trial Recruitment & Progress Your Pipeline

Synopsis

  • Advice on how to perfectly design your clinical trials
  • Learn how to minimise the risk of a failed clinical trial
  • Hear why certain clinical trials have been successes
  • Designing first-in-human clinical trials for live bacterial therapeutics
  • Healthy volunteers or straight into patients?
  • Biomarkers in early microbiome clinical trials

12:30 pm Precision Microbiome Profiling as a Tool to Support Successful Clinical Development and Market Introduction of Microbiome Modulating Drugs

Synopsis

• How to translate discoveries from Next Generation Sequencing into rapid and accurate microbiome profiling
• The benefits of rapid turnaround time in clinical development programs and final clinical applications
• The importance of absolute quantification at species and subspecies level for optimal microbiome profiling
• Examples of practical applications

1:00 pm Design of Microbiome Immuno-oncology Therapy From Mechanistic Principles

Synopsis

• Microbiome is associated with response to ICI therapy in GI tumor patients
• Cross reactive antigens (CRAgs) between microbiota and tumor are associated with patient response to ICI therapy
• CRAgs quality, such as overlap with virulence factors, are associated with patient response

TRACK C:
BEYOND THE GUT MICROBIOME

12:00 pm Learn About Scioto Biosciences Progression to Commercialization

Synopsis

  • Developing an activated bacterial therapeutic
  • Investment and scale through partnering
  • Outcomes of phase Ib clinical trial in patients with autistic disorder

12:30 pm A Journey With a CDMO & how Biose Industrie Makes the Difference in LBP Process Development and GMP Production

Synopsis

• Our History and why Biose is already moving into Phase III with pure LBP projects.
• The advantages of a one stop solution.
• Nearly 40 clinical lines for every conceivable LBP option. Anaerobic, GMO multi and single strains
• Numerous Drug Product solutions including encapsulation, sachets, liquids and oils and also tablets

1:00 pm Building Investor Confidence in Microbiome Drug Development; How to Promote & 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

1:30 pm Lunch & Networking

2:30 pm Current commercialization environment for microbiome therapeutics and FMT in Japan.

Synopsis

  • Landscape and up-to-date information about regulatory/policy/industry trends of microbiome therapeutics and FMT in Japan.
  • FMT platform of Metagen Therapeutics that enables research and industry partners access to microbiome/FMT data in Japan.

3:00 pm Function-based Approaches for Microbiome Research & Drug Development

  • Wei-Kai Wu Research Physician, Department of Medical Research, Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Department of Internal Medicine

Synopsis

  • An integrative platform of culturomics, metabolomics and gnotobiotic animals for translational microbiome research
  • Small molecule function-directed approaches-case, study 1
  • Large molecule function-directed approaches-case, study 2

3:30 pm Unlocking Access to Secondary Metabolites Through Cell-free Systems

Synopsis

  • How to scale up a cell-free approach to expressing novel chemicals
  • What cell-free systems could mean for the gut microbiome field
  • Summary of comparable approaches and why cell-free stands to win

4:00 pm Engineering the Skin Microbiome to Treat Skin Diseases

  • Travis Whitfill Co-Founder, Executive Director of Advanced Technology Chair, Scientific Advisory Board, Azitra

Synopsis

  • Engineering techniques to engineer skin commensals
  • Using engineered topical microbes to treat Netherton syndrome, a rare disease
  • Preclinical data and clinical plan of ATR-12, an engineered strain of S. epidermidis, for Netherton syndrome

2:30 pm Deep Dive Into the Gut-Brain Axis

Synopsis

• Discover the developments surrounding the CNS brain disorder, Parkinson’s Disease and Alzheimer’s Disease
• Discover the exciting emphasis on cognitive health that has the potential to transform the way we think about our mental health
• Understanding how we can better direct product development that would unlock this unique space in the field

3:00 pm A Human-First Discovery Approach: Leveraging Clinical Data to Identify Microbial Communities Driving Positive Clinical Outcomes

Synopsis

  • Utilizing data from human microbiota transplantation studies and machine learning to develop novel investigational microbiome therapeutics and retire risk early
  • An update on Finch’s clinical and preclinical pipeline
  • An update on latest clinical data supporting Finch’s lead product candidate, CP101, for the prevention of recurrent C. difficile infection

3:30 pm Understand How an Interventional Strategy of Metabolite Removal is Being Translated into a Clinical Setting

Synopsis

  • Microbial metabolites have been implicated in many neurological conditions, from neurodevelopmental and behavioral disorders to neurodegenerative diseases
  • Axial, in collaboration with its scientific founder, has established that metabolites derived from the gut microbiome can reach the brain and alter oligodendrocyte maturation, and hence myelination capacity, which can be tied to behavioral changes (Nature, accepted)
  • A resulting interventional strategy of metabolite removal is being translated into a clinical setting; Axial is developing AB-2004, a gut-retained sequestrant molecule, to manage irritability associated with autism. We plan to tell this mechanistic and translational story

4:00 pm Challenges in Lung Microbiome Modulation

Synopsis

  • Air liquid interface tissue culture work for translation in cystic fibrosis
  • Challenges of the murine pulmonary model
  • Addressing investor concerns regarding pulmonary microbe modulation

2:30 pm Translating Microbiome Data For Efficacious Product Development

Synopsis

• Key product developments insights to be had from analyzing microbiome data
• BIOHM has had success in translating raw microbiome insights into commercialized products
• Significant opportunities around AI applications to microbiome data

3:00 pm PANEL Discussion: Advancing Innovation in Microbiome Therapeutics Development Through Partnerships

Synopsis

  • Developing an activated bacterial therapeutic
  • Investment and scale through partnering
  • Outcomes of phase Ib clinical trial in patients with autistic disorder

3:30 pm Gut-brain Axis: Promising Pathways for Brain Health

Synopsis

• GBA and neurodegenerative disorders
• GBA and the immune system
• Recent GBA research: promising therapeutic avenues

4:00 pm Listen to how Partnerships & Collaborations Have Helped My-Biotics Successfully Create an Expansive Product Pipeline

Synopsis

  • MyBiotics’ SuperDonor technology – a unique disruptive technology for scalable and standardized artificial FMT
  • MBX-SD-202 – successful completion of Phase I safety with artificial FMT based on the SuperDonor technology
  • MBX-SD-202 – planned clinical development for recurrent C. diff infection

4:30 pm Afternoon Break & Networking

5:00 pm Microbiome Therapeutics to Transform the Treatment of Antimicrobial Resistant Infections

5:30 pm Microbiota Associated Microbial Drivers of Inflammatory Disease

Synopsis

  • Platform to identify microbiota-associated microbial drivers of inflammatory disease
  • Identification of lead organism implicated in a subset of patients with inflammatory bowel disease (IBD)
  • Discovery of a lead therapeutic molecule for the treatment of these patients

6:00 pm Close of the Conference