“Appreciated a good mix of new data, interesting companies, and relevant service providers”
~ Founder & Chief Executive Officer, Siolta Therapeutics
7:00 am Morning Check-In – Served with coffee + light breakfast
7:55 am Chair’s Opening Remarks
Securing Funding in 2025 & Mapping the Path to the Next LBP Approval
8:00 am Pioneering the Future of Microbiome Therapeutics: Assessing Clinical Progress & Outlining Market Opportunities
Synopsis
- Evaluating clinical progress by analysing existing approvals and late-stage clinical trial candidates
- Unlocking new market opportunities in oncology, women’s health, and metabolic disorders while navigating pharma investment trends
- Assessing the current progress of incorporating advanced technologies like AI-driven microbiome analysis, synthetic biology, and scalable manufacturing to accelerate innovation
8:30 am Biose Industrie: Developing & Manufacturing Two Multi-Strain Live Biotherapeutic Products for Clinical Studies
9:00 am Microbiome Clinical Landscape Review
Synopsis
- Explore the clinical landscapes of Microbiome drug development
- Reveal therapeutic modalities, therapy-specific properties, and disease indications gaining traction
- Give an analysis of the commercial landscape driving the clinical development of the space
9:30 am MaaT013: The First Phase 3 Trial for Microbiome Therapy in Hemato-Oncology
Synopsis
- Discussing the ongoing pivotal Phase 3 ARES trial for MaaT013 in patients with acute Graft-versus-Host Disease (GI-aGvHD) and its significance as the first global Phase 3 trial for a microbiome-based therapy in hemato-oncology
- Highlighting the Orphan Drug Designation from both the FDA and EMA, and the positive outcomes from the Data Safety Monitoring Board (DSMB) review.
- Exploring the positive Phase 3 ARES results, evaluating MaaT013’s unprecedented efficacy as a third-line treatment for GI-aGvHD
10:00 am Structured Networking Break
Synopsis
Make the most of this morning networking session to reconnect with your industry and meet fellow microbiome pioneers. Use this opportunity effectively to connect with cross-industry stakeholders and form important connections for expediting your platform development
Advancing GI & Infectious Diseases Track
Revolutionize GI Therapeutics: Pioneering Late-stage Developments & Innovative Treatments for C. Difficile and GI Disorders
11:00 am Clinical Update on C. diff Candidate RBX2660
Synopsis
- Discussing the pivotal Phase 3 trial results of RBX2660, demonstrating its superior efficacy in reducing recurrence of Clostridioides Difficile Infection (CDI)
- Explore the significance of FDA approval and breakthrough therapy designation for RBX2660, and its impact on accelerating the development and availability of this microbiome-based therapeutic
- Future Directions and Applications: Examine the potential expansion of RBX2660’s use in other high-risk patient populations and the ongoing efforts to address unmet medical needs in gastrointestinal health
11:30 am First Non-Antibiotic Antibiotic: MBK-01 Capsules Compared to Fidaxomicin for the Treatment of Primary & Recurrent Clostridioides Difficile Infection
Synopsis
- Presenting Phase 3 efficacy and safety data for MBK-01, a non-antibiotic therapy for Clostridioides difficile infection
- Exploring real-world evidence findings and insights from the compassionate use program
- Expanding clinical research efforts into new therapeutic areas for MBK-01
Expanding Pipelines with New Indications Track
Microbiome’s Role in Cancer Therapy: Unveiling the Gut Microbiome’s Impact on Cancer Diagnostics & Treatment Efficacy
11:00 am MVT-201 as an Adjuvant to Anti-PD1 in Melanoma
11:30 am KAN-001, a Complex Consortium Live Biotherapeutic Product to Augment Cancer Therapy
Synopsis
- From FMTs to LBPs: A reverse translational approach to creating an optimized and sustainable therapy to augment patients’ immune systems and response to cancer immune checkpoint therapy
- KAN-001 optimization and preclinical testing
- KAN-001 strains in patients: assessing existing KAN-001 strain-level clinical engraftment data de-risks development
12:30 pm Lunch & Networking
Mapping Out the Microbiome & Strategies for Manufacturing Consistency, Stability & Scalability
1:30 pm A Platform for Rationally Designing and Controlled Manufacturing of Complex Consortia Products that combine the Functional Diversity and Activity of Healthy Microbiomes with Scalable, Consistent and MoA-targeted Consortia
Synopsis
- Enabling precise identification and quantification of individual strains within complex consortia, allowing for potency assessment and process control in manufacturing
- Addressing co-culture challenges by stabilizing microbial communities through rational product design and advanced fermentation strategies
- Ensuring scalability, reproducibility, and quality control of high-diversity microbial therapeutics
- Strategically integrating strain-specific mechanisms with host-microbiome interactions
2:00 pm Development of Microbiological Examination Methods for Live Biotherapeutic Products
Synopsis
- Complications with traditional methods
- Existing guidance for objectionable organism testing in LBPs
- Alternative methods for detecting and identifying objectionable organisms
2:30 pm Advancing Assay Development for Multi-Strain Live Biotherapeutic Products
Synopsis
- The next generation of complex live biotherapeutic products demands advanced analytical approaches beyond sequencing to accurately assess potency, efficacy, and safety
- Kanvas has developed a spatial imaging platform that provides unprecedented resolution in evaluating microbial interactions and the host-microbe interface
- This technology enhances strain isolation, refines process development by characterizing strain-strain interactions, and enables more precise potency assays to meet evolving regulatory and clinical validation requirements
3:00 pm 3:00 Advancing Assay Development for Multi-Strain Live Biotherapeutic Products
Synopsis
- Developing assays to evaluate the potency of multi-strain LBPs
- Key considerations for potency assay development and validation for late-stage clinical studies of LBPs
3:30 pm Panel Discussion: Scaling Up Manufacturing for Clinical Trials of LBPs
Synopsis
- Scaling up LBP production from preclinical to late-stage clinical trial quantities by maintaining microbial consistency, stability, and product quality at larger scales
- Managing the supply chain and logistics for late-stage trials by ensuring reliable and timely delivery of LBPs, including temperature-sensitive storage, transportation, and distribution to multiple clinical sites
- Navigating regulatory requirements during late-stage trials by balancing manufacturing compliance with the strict demands for clinical-grade products and preparing for commercialization
Translating Microbiome Learnings to Women’s Health & Gut-Brain Axis for CNS Indications
1:30 pm Impact of Vaginal Products on the Vaginal Microbiome
Synopsis
- Regulatory insights into clinical assessments during clinical trials
- Clinical trial data showcasing contraceptive studies and impact on the microbiome
- New approaches to Improving vaginal health
2:00 pm Learnings from Clinical Development with MH002 in IBD and Translation to LBP Development for Parkinson’s Disease
Synopsis
- Reviewing Phase 2 clinical data of MH002, a next-generation microbiome therapy utilizing MRM Health’s CORAL® Technology, combining six commensal strains for targeted action in Ulcerative Colitis (UC) and Pouchitis
- Lessons learned and highlights on its ability to restore gut microbiome balance and improve clinical outcomes
- Translation of knowhow from clinical program to develop LBPs for Parkinson’s Disease; update on preclinical data
4:00 pm Scientific Poster Session
Synopsis
This is an informal session to help you connect with your peers in a relaxed atmosphere to continue forging new and beneficial relationships. With an audience of preclinical, translational, and clinical scientists eager to hear the latest advancements in Microbiome therapeutic development, you will have the opportunity to display a poster presenting your own work and innovations. Get in touch to apply: info@hansonwade.com
4:30 pm Afternoon Break & Refreshments
Bridging the Gap: Clinical Innovations in Microbiome Therapeutics & The Convergence of Consumer Health with Pharmaceuticals
5:00 pm Fireside Chat: Unlocking Pharma & Investor Buy-In
Synopsis
- Understanding the cautious approach of large pharma towards microbiome investments and the factors shaping their decisions
- Analyzing recent strategic partnerships and investment trends to uncover what drives value in microbiome-based innovations
- Discussing key considerations for forging successful partnerships with big pharma and aligning biotech strategies with industry needs to drive mutual growth
5:30 pm Panel Discussion: From Consumer Success to Clinical Impact: How Direct-to-Consumer Microbiome Products Are Shaping Therapeutic Breakthroughs
Synopsis
- Evaluating clinical trial strategies for direct-to-consumer microbiome products: costs, regulatory pathways, and scientific credibility
- Analyzing the economic viability of trial-based models in the DTC space: profitability, investor interest, and commercialization speed
- Navigating marketing and regulatory constraints for microbiome therapeutics in a consumer-driven landscape
6:00 pm 10th Annual Microbiome Movement Awards
Synopsis
The 10th Annual Microbiome Movement Awards will celebrate groundbreaking achievements and exceptional contributions in microbiome research and therapeutics. This prestigious event highlights the innovative companies, researchers, and thought leaders driving the microbiome field forward. Through a series of award categories, the ceremony will recognize advancements in microbiome-based drug discovery, novel therapeutic applications, pioneering technologies, and leadership within the microbiome ecosystem.