Funding Overview
mbiomics, a Munich-based biotech startup, closed a EUR 30 million Series A funding round to scale its Live Biotherapeutic Products (LBPs) for severe chronic diseases. The funding marks the company's transition from platform development to clinical execution.
The round was led by MIG Fonds and Bayern Kapital. The round included a recent third closing of EUR 12 million, demonstrating strong investor confidence in the company's approach.
This funding will enable mbiomics to advance its lead candidate toward clinical trials and expand its manufacturing capabilities.
The Challenge of Scaling Microbiome Therapeutics
While the clinical potential of the gut microbiome is well understood, transforming microbiome-based therapeutics into scalable products has remained a significant engineering challenge.
Traditional approaches like fecal microbiota transplants (FMTs) are variable and difficult to scale, lacking the consistency required for pharmaceutical-grade manufacturing. Each donor provides different microbial compositions, leading to inconsistent patient outcomes.
The challenge lies in rationally designing complex microbial consortia, screening and analyzing patient-specific data, and manufacturing live bacterial strains at scale under GMP conditions. The complexity of the microbiome makes this particularly challenging.
Additionally, regulatory pathways for live biotherapeutic products are still evolving, requiring careful navigation of FDA and EMA requirements.
Technology Platform
mbiomics uses a proprietary technology stack to create rationally designed Live Biotherapeutic Products. The platform combines AI/ML-driven design, precision analytics, scalable manufacturing, and oral therapeutic delivery.
The platform enables the design of defined microbial consortia with specific therapeutic properties, moving beyond the variability of traditional FMT approaches. Each LBP is composed of precisely characterized bacterial strains.
AI and machine learning accelerate the identification of optimal strain combinations and manufacturing processes, reducing development time and costs.
Lead Candidate: MBX-116
The company's lead candidate, MBX-116, targets second-line melanoma as an oncology co-therapy with immune checkpoint inhibitors. The strategy aims to improve patient response rates by modulating the gut microbiome.
Clinical evidence suggests that modulating the gut microbiome can significantly improve response rates to existing immune checkpoint inhibitors. This addresses a significant unmet need in oncology.
A Phase 1B study is planned to commence in 2027, with the goal of demonstrating safety and preliminary efficacy in melanoma patients.
Future Pipeline
Beyond oncology, mbiomics plans to expand into:
- Autoimmune diseases - targeting conditions like inflammatory bowel disease and multiple sclerosis
- Neurodegenerative diseases - exploring the gut-brain axis for conditions like Parkinson's disease
- Metabolic disorders - addressing conditions like type 2 diabetes and non-alcoholic fatty liver disease
Leadership
mbiomics was founded in 2020 by Dr. Johannes B. Woehrstein (CTO), Dr. Markus Rinecker (CMO), and Dr. Laura Figulla (CEO). The team brings extensive experience in microbiology, pharmaceutical development, and clinical translation.
Dr. Woehrstein's background includes computational biology and microbiome research. Dr. Rinecker brings clinical development expertise from major pharmaceutical companies. Dr. Figulla has extensive experience in company building and fundraising.
Funding Details
Key investors include MIG Fonds (lead) and Bayern Kapital (lead). These German investors bring deep expertise in biotech and healthcare investments.
Use of capital:
- Accelerate GMP development and manufacturing
- Strengthen IND-enabling pharmacological data sets
- Advance lead candidate MBX-116 toward clinical trials
- Expand research and development capabilities
Market Opportunity
The microbiome therapeutics market is growing rapidly, with applications across oncology, autoimmune diseases, metabolic disorders, and neurological conditions.
Key growth drivers include increasing understanding of the gut microbiome's role in health and disease, rising interest in personalized medicine, and growing evidence for microbiome-based interventions.
mbiomics' rationally designed LBPs offer advantages over FMTs in consistency, scalability, and regulatory pathway clarity. The defined nature of the products enables more predictable clinical outcomes.
Looking Ahead
mbiomics is positioned to advance its lead candidate into clinical trials and expand its platform into additional indications. Success will depend on demonstrating clinical efficacy, maintaining robust manufacturing processes, and executing on the oncology co-therapy strategy.
The company plans to pursue partnerships with major pharmaceutical companies to accelerate development and commercialization of its pipeline.
Clinical Development Strategy
MBX-116 will be developed as a co-therapy with established checkpoint inhibitors. This approver pathway could accelerate approval.
Biomarker studies will identify patient populations most likely to benefit from microbiome modulation.
Manufacturing Infrastructure
The company is building GMP manufacturing capacity in Munich. The modular design enables rapid scale-up.
Quality Systems
Comprehensive quality management systems ensure consistent product quality. The defined composition enables precise quality control.
Regulatory Interactions
Active dialogue with FDA and EMA has clarified regulatory requirements for live biotherapeutic products.
Partnerships
Academic collaborations provide access to cutting-edge microbiome research. Pharma partnerships support commercialization.
Market Access
The company is building market access capabilities across major geographies.
Gut-Immune Axis Science
The gut microbiome influences immune function through multiple mechanisms including metabolite production, immune education, and mucosal barrier function.
Specific bacterial metabolites can enhance or suppress immune responses. MBX-116 is designed to restore beneficial metabolites in cancer patients.
Checkpoint Inhibitor Combination
Combining microbiome modulation with checkpoint inhibitors addresses a key resistance mechanism. Up to 60% of patients do not respond to checkpoint inhibitors alone.
Biomarker Strategy
Patient selection will be informed by microbiome analysis. Certain bacterial signatures predict response to immune therapy.
Personalized Approach
While the product is defined, patient selection can be personalized based on microbiome profiling.
Regulatory Classification
LBPs are regulated as biologics under FDA and EMA frameworks. Compliance with cGMP requirements is essential.
CMC Development
Chemistry, Manufacturing, and Controls development focuses on一致性 and scalability of the defined consortia.
Analytical Methods
Comprehensive analytical methods ensure identity, purity, potency, and stability of each LBP.
Research Collaboration
Academic partnerships with leading microbiome research groups provide access to cutting-edge science. These collaborations support ongoing platform development.
The company sponsors research at multiple universities to advance understanding of the gut microbiome in health and disease.
Scientific Publications
Peer-reviewed publications in leading journals establish scientific credibility and support clinical development. Multiple manuscripts are in preparation.
Pipeline Expansion
Beyond MBX-116, the company is developing additional candidates for different disease indications. These programs are in earlier stages of development.
Commercial准备
Market research and commercial strategy development are underway to prepare for potential product launch.
Patient Access Programs
Early access programs may be considered in regions with unmet medical needs following regulatory approvals.