The Munich techbio company is developing a live bacterial product designed to enhance immune checkpoint inhibitor response in advanced melanoma, with a Phase 1B study planned for 2027

mbiomics GmbH, a Munich-based techbio company developing microbiome-based therapeutics, has completed the third and final closing of its Series A funding round, bringing the total raised to €30 million.

The latest €12 million tranche was provided by existing investors MIG Fonds and Bayern Kapital, and marks the conclusion of a round that began in March 2023.

The capital will fund two near-term priorities: strengthening the IND-enabling pharmacological data package for the company’s lead candidate MBX-116, and accelerating the GMP-grade manufacturing development required to produce it at the clinical scale needed for human trials. The goal is a Phase 1B study in second-line advanced melanoma, planned to begin in 2027.

“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.

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“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, mbiomics sits 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 distinction from earlier-generation microbiome interventions matters: faecal microbiota transplants (FMTs) have demonstrated clinical efficacy across multiple conditions but are inherently variable, non-standardised, and difficult to manufacture at scale. mbiomics’ platform is designed to replace FMT’s empirical variability with a rationally designed, reproducible product.

The platform combines AI and machine-learning-driven consortia design, proprietary high-resolution analytical technology, and large-consortium co-cultivation and screening capabilities.

The AI layer is used not just to identify candidate bacterial strains but to design the specific combination, the consortia, most likely to produce a defined therapeutic effect in a defined patient population.

This approach to rational consortia design, rather than single-strain probiotics or empirical transplants, is where mbiomics positions itself as a step-change from what came before it.

mbiomics’ lead clinical target, MBX-116 as a co-therapy alongside immune checkpoint inhibitors in second-line advanced melanoma, is grounded in a well-established but still-developing body of clinical evidence.

The gut microbiome modulates the immune system through multiple mechanisms: microbial metabolites, including short-chain fatty acids and tryptophan-derived compounds, regulate immune cell activation, dendritic cell activity, and the development of regulatory T cells, collectively shaping whether the immune system mounts a strong enough anti-tumour response.

Clinically, the relationship between microbiome composition and checkpoint inhibitor response has been documented in several studies. 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 had 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 mechanistically linked to enhanced effector T cell activity.

The €30 million total is relatively modest by the standards of late-preclinical biotech rounds, but mbiomics is 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 approximately 18 months from now to reach IND submission and trial initiation, an achievable timeline for a company at this stage if GMP manufacturing comes together on schedule.

Beyond oncology, mbiomics has described a broader pipeline of microbiome-based therapeutics targeting indications including autoimmune and neurodegenerative diseases, indications where the gut–brain axis and gut–immune axis connections have generated increasing research interest but where no therapeutic-grade LBP has yet reached late-stage clinical development.

If the company pursues those indications independently or in partnership will likely be shaped by the results of the melanoma trial.