Munich’s mbiomics raises €30M for live bacterial therapy

A Munich-based techbio company has secured €30 million in Series A funding to advance a live bacterial therapy designed to boost immune checkpoint inhibitor response in advanced melanoma. The company’s lead candidate, MBX-116, targets second-line treatment for the disease, with a Phase 1B study planned to begin in 2027.

mbiomics GmbH completed the third and final closing of its Series A round, adding a €12 million tranche from existing investors MIG Fonds and Bayern Kapital. This marks the end of a fundraising effort that started in March 2023. The fresh capital will be directed toward two immediate priorities: strengthening the IND-enabling pharmacological data package for MBX-116 and accelerating GMP-grade manufacturing development needed for clinical-scale production.

“While the clinical potential of the gut microbiome is well understood, transforming microbiome-based therapeutics into a scalable product has remained a significant engineering challenge,” said Dr. Johannes B. Woehrstein, CEO and co-founder of mbiomics. “At mbiomics, we are solving this challenge by building the full technology stack 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, the company operates at the intersection of microbiology, AI-driven drug design, and precision medicine. Its core product class is Live Biotherapeutic Products (LBPs), oral therapeutics composed of defined combinations of live bacterial strains delivered in a pharmaceutical-grade format.

The approach marks a departure from earlier-generation microbiome interventions like faecal microbiota transplants (FMTs). While FMTs have shown clinical efficacy, they suffer from inherent variability, lack of standardisation, and manufacturing challenges at scale. mbiomics’ platform aims to replace that empirical variability with a rationally designed, reproducible product. The system combines AI and machine-learning-driven consortia design, proprietary high-resolution analytical technology, and large-consortium co-cultivation and screening capabilities. The AI layer not only identifies candidate bacterial strains but also designs the specific combination most likely to produce a defined therapeutic effect in a defined patient population.

The lead clinical target, MBX-116 as a co-therapy alongside immune checkpoint inhibitors in second-line advanced melanoma, builds on a growing body of clinical evidence. The gut microbiome modulates the immune system through multiple mechanisms, including microbial metabolites like short-chain fatty acids and tryptophan-derived compounds that regulate immune cell activation, dendritic cell activity, and regulatory T cell development. These processes collectively shape the strength of the anti-tumour response.

Clinical studies have documented the relationship between microbiome composition and checkpoint inhibitor response. A landmark trial by Routy et al. found that FMT from ICI-responsive donors significantly improved outcomes in patients with refractory melanoma, with objective response rates reaching 65% in some cohorts. Conversely, patients who received broad-spectrum antibiotics within 30 days of starting checkpoint inhibitor therapy, which disrupts the gut microbiome, consistently showed worse outcomes across multiple tumour types. Specific bacterial taxa, including Akkermansia muciniphila and Faecalibacterium prausnitzii, have been repeatedly identified as enriched in ICI responders and linked to enhanced effector T cell activity.

The €30 million total is modest by late-preclinical biotech standards, but mbiomics remains an IND-stage company. It is still completing the pharmacological data package required to file an Investigational New Drug application with regulators. The Phase 1B trial target of 2027 gives the company roughly 18 months to reach IND submission and trial initiation, a timeline that appears achievable if GMP manufacturing proceeds as planned.

Beyond oncology, mbiomics has outlined a broader pipeline targeting indications such as autoimmune and neurodegenerative diseases, areas where the gut–brain axis and gut–immune axis connections have generated increasing research interest. No therapeutic-grade LBP has yet reached late-stage clinical development in these fields. Whether the company pursues those indications independently or through partnerships will likely depend on results from the melanoma trial.