Munich-based texbio is developing a live bacterial product designed to boost immune checkpoint inhibitor response in advanced melanoma with a Phase 1B study scheduled for 2027.
mbiomics GmbHtexbio, a Munich-based developer of microbiome-based therapeutics, has closed its third and final Series A funding round, bringing the total to €30 million.
The latest tranche of €12 million was provided by existing investors MIG Fonds and Bayern Kapital and marks the end of the round, which started in March 2023.
The capital will fund two near-term priorities: strengthening the IND-enabling pharmacologic data package for the company’s lead candidate, MBX-116, and accelerating the development of GMP-level manufacturing required for clinical-scale manufacturing necessary for human trials. The goal is a Phase 1B study in secondary advanced melanoma scheduled to begin in 2027.
“While the clinical potential of the gut microbiome is well understood, turning microbiome-based therapeutics into scalable products remains an important engineering challenge.” CEO and co-founder of mbiomics Dr. Johannes B. Woehrstein said.
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“At mbiomics, we address this challenge by building a complete technology stack for the design, analysis, screening and production of complex microbial consortia.”
In 2020 in Munich, Woehrstein, Dr. Markus Rinecker and Dr. Founded by Laura Figulla, mbiomics lies at the intersection of microbiology, AI-guided drug design, and precision medicine.
Its main product class is Live Biotherapeutic Products (LBPs), oral therapeutics composed of defined combinations of live bacterial strains, delivered in a pharmaceutical-grade format.
A distinction from previous generations of microbiome interventions is important: faecal microbiota transplantation (FMT) has demonstrated clinical efficacy in many settings, but is inherently variable, unstandardized, and difficult to scale. The mbiomics platform is designed to replace the empirical variability of FMT with a rationally designed, reproducible product.
The platform combines artificial intelligence and machine learning-driven consortium design, proprietary high-resolution analytics technology, and large consortium co-cultivation and validation capabilities.
The AI layer is used not only to identify candidate bacterial strains, but to design specific combinations, consortia, that may produce a defined therapeutic effect in a given patient population.
Rather than single-type probiotics or empirical transplants, this approach to rational consortium design is where mbiomics positions itself as a step change from its predecessors.
MBX-116, the lead clinical target of mbiomics, is based on a well-established but still evolving body of clinical evidence as a combination therapy alongside immune checkpoint inhibitors in secondary advanced melanoma.
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 shaping whether the immune system mounts a strong enough anti-tumor response.
Clinically, the relationship between microbiome composition and checkpoint inhibitory response has been documented in several studies. A landmark trial by Routy et al. found that FMT from donors who responded to ICI 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 gut microbiome-disrupting checkpoint inhibitor therapy consistently showed worse outcomes across multiple tumor types.
Specific bacterial taxa, incl Akkermansia muciniphila and Faecalibacterium prausnitziiwas found to be mechanistically associated with enriched and enhanced effector T cell activity in multiple ICI responders.
A total of €30 million is relatively modest by the standards of late-stage preclinical biotech rounds, but mbiomics is an IND-stage company: it is still completing the pharmacological data package required to submit an Investigational New Drug application to regulators.
The Phase 1B trial target of 2027 gives the company approximately 18 months to reach an achievable IND submission and trial initiation for the 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, gut-brain axis and gut-immune axis connections, where there has been growing research interest, but where no therapeutic-grade LBP has been in recent development.
Whether the company pursues these indications independently or jointly will likely be shaped by the results of melanoma trials.
