Munich company techbio is developing a live bacterial product designed to enhance the immune checkpoint inhibitory response in advanced melanoma, with a phase 1B study planned for 2027.
mbiomics GmbHA Munich-based technology company developing microbiome-based therapies, has completed the third and final closing of its Series A financing round, bringing the total raised to €30 million.
The latest tranche of €12 million 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 drug data package for the company’s lead candidate, MBX-116, and accelerating the GMP-grade manufacturing development needed to produce it at the clinical scale needed for human trials. The objective is a Phase 1B study in second-line advanced melanoma, scheduled to begin in 2027.
“While the clinical potential of the gut microbiome is well understood, transforming microbiome-based therapies into a scalable product remains 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 a complete technology stack for the design, analysis, detection 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 primary product class is live biotherapeutics (LBPs), oral therapies composed of defined combinations of live bacterial strains, delivered in a pharmaceutical-grade format.
The distinction with previous generation microbiome interventions is important: fecal microbiota transplants (FMTs) have demonstrated clinical efficacy in multiple conditions, but are inherently variable, non-standardized, and difficult to manufacture at scale. The mbiomics platform is designed to replace the empirical variability of FMT with a rationally designed, reproducible product.
The platform combines AI and machine learning-driven consortium design, proprietary high-resolution analytical technology, and large consortium screening and co-cultivation capabilities.
The AI layer is used not only to identify candidate bacterial strains, but also to design the specific combination, consortia, that are 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 is positioned as a radical departure from what preceded it.
The primary clinical target of mbiomics, MBX-116 as co-therapy along with immune checkpoint inhibitors in second-line advanced melanoma, is based on 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 regulatory T cell development, collectively determining whether the immune system mounts a sufficiently strong antitumor 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 donors responding to ICI significantly improved outcomes in patients with refractory melanoma, with objective response rates reaching 65% in some cohorts.
In contrast, patients who had received broad-spectrum antibiotics within 30 days of starting therapy with checkpoint inhibitors, which alter the gut microbiome, consistently showed worse outcomes across multiple tumor types.
Specific bacterial taxa, including Akkermansia muciniphila and Faecalibacterium prausnitziihave been repeatedly identified as enriched in ICI responders and mechanistically linked to increased 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 drug 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 filing and trial initiation, an achievable timeline for a company at this stage if GMP manufacturing proceeds as planned.
Beyond oncology, mbiomics has described a broader range of microbiome-based therapies targeting indications including autoimmune and neurodegenerative diseases, indications where connections between the gut-brain axis and the gut-immune axis have generated growing research interest, but where no therapeutic-grade low back pain has yet reached an advanced stage of clinical development.
Whether the company pursues those indications independently or in partnership will likely depend on the results of the melanoma trial.
