Munich-based mbiomics secures €30 million to advance the development of a live bacterial product.

      The Munich-based techbio company is working on a live bacterial product aimed at improving the response to immune checkpoint inhibitors in advanced melanoma, with plans for a Phase 1B study scheduled for 2027.

      mbiomics GmbH, specializing in microbiome-based therapeutics, has completed the final closing of its Series A funding round, raising a total of €30 million. The latest €12 million injection came from existing investors MIG Fonds and Bayern Kapital and signifies the end of a funding round that began in March 2023.

      This funding will support two immediate objectives: enhancing the IND-enabling pharmacological data package for the leading candidate MBX-116 and expediting the development of GMP-grade manufacturing needed for clinical-scale production. The aim is to initiate a Phase 1B study for second-line advanced melanoma in 2027.

      “While the potential of the gut microbiome in clinical settings is widely recognized, developing microbiome-based therapeutics into a scalable product has proven to be a significant engineering hurdle,” stated Dr. Johannes B. Woehrstein, CEO and co-founder of mbiomics.

      “At mbiomics, we are addressing this challenge by creating the comprehensive technology framework for the design, analysis, screening, and manufacturing of complex microbial consortia.”

      Founded in Munich in 2020 by Woehrstein, Dr. Markus Rinecker, and Dr. Laura Figulla, mbiomics operates at the crossroads of microbiology, AI-enhanced drug design, and precision medicine.

      Its primary product line consists of Live Biotherapeutic Products (LBPs), which are oral therapeutics made from specific combinations of live bacterial strains, delivered in a pharmaceutical-grade formulation.

      This differentiates them from earlier microbiome interventions: fecal microbiota transplants (FMTs) have shown clinical efficacy across various conditions but are inherently variable, non-standardized, and challenging to manufacture at scale. mbiomics’ platform aims to substitute the empirical variability of FMTs with a systematically designed, reproducible product.

      The platform integrates AI-driven consortia design, proprietary high-resolution analysis technology, and extensive co-cultivation and screening capabilities.

      The AI component is utilized not only for identifying candidate bacterial strains but also for designing specific combinations of consortia likely to achieve a particular therapeutic effect in a defined patient demographic.

      This rationale in consortia design—moving beyond single-strain probiotics or empirical transplants—is how mbiomics seeks to differentiate itself from previous approaches.

      mbiomics’ primary clinical focus, MBX-116, is aimed at being a co-therapy alongside immune checkpoint inhibitors in second-line advanced melanoma, supported by an accumulating body of clinical evidence.

      The gut microbiome influences the immune system through various mechanisms: microbial metabolites, such as short-chain fatty acids and tryptophan-derived compounds, regulate immune cell activation, dendritic cell activity, and the formation of regulatory T cells, all of which impact the immune system's ability to launch a sufficient anti-tumor response.

      The association between microbiome composition and checkpoint inhibitor efficacy has been documented in numerous studies. A pivotal trial by Routy et al. demonstrated that FMT from donors responsive to immune checkpoint inhibitors significantly improved outcomes for patients with refractory melanoma, achieving objective response rates of up to 65% in certain groups. Conversely, patients who had taken broad-spectrum antibiotics within 30 days prior to starting checkpoint inhibitor therapy, which disrupts the gut microbiome, consistently experienced poorer outcomes across multiple tumor types.

      Specific bacterial taxa, such as Akkermansia muciniphila and Faecalibacterium prausnitzii, have been repeatedly identified as more prevalent in ICI responders and are mechanistically associated with increased effector T cell activity.

      While the €30 million total funding may seem modest relative to late-preclinical biotech rounds, mbiomics is still in the IND-stage: it is finalizing the pharmacological data package necessary to submit an Investigational New Drug application to regulatory bodies.

      The target date for the Phase 1B trial in 2027 gives the company about 18 months to complete the IND submission and begin the trial—an achievable timeline for a company at this stage, provided GMP manufacturing proceeds as planned.

      In addition to oncology, mbiomics has outlined a wider pipeline of microbiome-based therapeutics aimed at conditions such as autoimmune and neurodegenerative diseases. These indications, which have garnered increasing research interest due to the gut–brain and gut–immune axis connections, have yet to see a therapeutic-grade LBP reach late-stage clinical trials. The company's decisions to pursue these indications independently or through partnerships will likely be influenced by the results of the melanoma trial.