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mbiomics

Company Overview

A Munich-based biotech developing live biotherapeutic products designed to potentiate immune checkpoint inhibitor therapy in advanced melanoma, with EUR 30 million in Series A funding now backing its first clinical push. mbiomics GmbH engineers oral therapeutics composed of defined live bacterial strains to restore the functional and metabolic potential of the gut microbiome — a mechanism with documented relevance to ICI response rates. The company's thesis is that microbiome dysfunction is not a bystander phenomenon in immune-oncology non-responders but a tractable therapeutic target. Lead candidate MBX-116 is being positioned as a co-therapy in second-line advanced melanoma, with a Phase IB study planned for 2027.

Headquarters and Global Presence

mbiomics is headquartered in Munich, Bavaria, and operates as a privately held GmbH. The company's activities are concentrated in the Munich life sciences cluster, drawing on the regional ecosystem that includes LMU and TU Munich research networks, with GMP manufacturing scale-up underway to support clinical entry.

Founding and History

mbiomics was founded in 2020 by Laura Figulla, Markus Rinecker, and Johannes Woehrstein. The company completed a Series A financing in multiple tranches, closing the third and final tranche of EUR 12 million in April 2026 to reach a total of EUR 30 million raised. Total funding stands at approximately USD 35 million, with backing from MIG Fonds/MIG Capital and Bayern Kapital throughout the round. The April 2026 close marked an explicit transition, in management's own framing, from platform construction to clinical execution.

Therapy Areas and Focus

The primary focus is immuno-oncology, specifically addressing primary and acquired resistance to immune checkpoint inhibitors — a problem that affects the majority of advanced melanoma patients treated with anti-PD-1 or anti-CTLA-4 agents. The gut microbiome's role in modulating systemic immune tone and ICI efficacy is now well-established in the literature, but translating that observation into a defined, reproducible therapeutic product remains the field's unsolved challenge. mbiomics is also developing pipeline programs targeting autoimmune and neurodegenerative indications, where the gut-immune axis is similarly implicated. The commercial logic is compelling: melanoma provides a relatively accessible ICI combination entry point before broader expansion.

Technology Platforms and Modalities

mbiomics develops Live Biotherapeutic Products — orally administered formulations of defined, characterized bacterial strains rather than broad-spectrum fecal transplants. The platform is designed to restore specific functional and metabolic capacities of a dysbiotic microbiome, targeting immune pathway modulation rather than non-specific community reconstitution. This precision approach is what distinguishes mbiomics from earlier-generation FMT strategies and positions its products within the FDA/EMA LBP regulatory framework. GMP-compatible manufacturing is being developed in parallel with IND-enabling studies, which the Series A proceeds are specifically earmarked to fund.

Key Pipeline and Programs

MBX-116 is the company's lead asset — an oral live biotherapeutic product comprising defined bacterial strains selected for their capacity to modulate gut-immune crosstalk. The intended indication is second-line or advanced melanoma, administered in combination with standard-of-care immune checkpoint inhibitors. A Phase IB safety and tolerability study is planned to initiate in 2027, making completion of IND-enabling pharmacological packages the near-term operational priority. The combination hypothesis rests on microbiome composition data linking specific bacterial taxa to ICI response, and MBX-116's strain selection reflects that mechanistic rationale. Preclinical programs in autoimmune disease and neurodegeneration represent earlier-stage pipeline entries, with no clinical timelines yet disclosed for those indications.

Recent Developments

On April 28, 2026, mbiomics closed the third tranche of its Series A at EUR 12 million, completing the full EUR 30 million round. Existing investors MIG Fonds/MIG Capital and Bayern Kapital participated in the final close. The capital is directed at GMP manufacturing readiness and IND-enabling pharmacological datasets — the two prerequisites for the planned 2027 Phase IB entry. No clinical data readouts, partnership announcements, or leadership changes have been reported in the preceding twelve months beyond the financing close.

Key Personnel

Laura Figulla serves as a co-founder and is part of the founding leadership team; she co-established mbiomics alongside Markus Rinecker and Johannes Woehrstein in 2020. Dr. Christopher Weidenmaier serves as Chief Scientific Officer, providing the scientific leadership guiding platform development and pipeline strategy. The three co-founders bring a combination of entrepreneurial and scientific backgrounds drawn from the Munich biotech and academic research environment.

Strategic Partnerships

No formal commercial licensing or co-development partnerships have been publicly announced to date. Investor backing from MIG Fonds/MIG Capital — one of Germany's most active life sciences venture firms — and Bayern Kapital, the Bavarian state development fund, provides both financial and strategic support. The company appears to be advancing MBX-116 independently through IND-enabling activities ahead of any anticipated partnership discussions around or after Phase IB data generation.

FAQ Section

The strategy reflects where the clinical evidence is strongest. Multiple published studies have demonstrated that gut microbiome composition at baseline predicts ICI response in melanoma patients, and that dysbiosis correlates with primary resistance. Positioning MBX-116 as a co-therapy lets mbiomics ride an established clinical infrastructure — anti-PD-1 regimens are already standard-of-care — while addressing a mechanistically grounded gap that checkpoint inhibitors alone cannot fill. It is also a lower-risk regulatory entry than a standalone oncology agent.

The gut microbiome shapes systemic immune tone through multiple pathways: production of short-chain fatty acids, modulation of regulatory T-cell populations, and direct stimulation of dendritic cells and NK cells. In melanoma specifically, bacteria such as Faecalibacterium prausnitzii and Bifidobacterium longum have been associated with better ICI outcomes in independent clinical cohorts. The therapeutic hypothesis is that restoring a pro-immunogenic microbiome state with a defined LBP can shift non-responders toward a response-permissive phenotype — a fundamentally different mechanism from adding a second checkpoint inhibitor.

FMT trials in oncology — including published work from Israel and the Netherlands in melanoma — use uncharacterized donor material, which creates variability, safety complexity, and regulatory ambiguity. mbiomics works with defined, manufactured bacterial strains, enabling reproducible dosing, GMP production, and a cleaner regulatory path under the LBP framework that both the FDA and EMA have been developing. The defined composition also makes mechanism-of-action attribution tractable, which matters for combination therapy label claims and future partnership conversations.

MBX-116 is an oral live biotherapeutic product comprising selected bacterial strains designed to restore immune-modulatory microbiome function in patients with advanced melanoma receiving ICI therapy. It remains in late preclinical/IND-enabling stage as of mid-2026, with a Phase IB combination safety study planned for 2027. The EUR 30 million Series A is specifically structured to fund the GMP manufacturing buildout and pharmacological datasets required to file the IND. No clinical data exist yet — the investment case is built on the preclinical package and the team's ability to execute the 2027 entry timeline.

The company has disclosed pipeline interest in autoimmune diseases and neurodegeneration, reflecting the established literature on the gut-immune and gut-brain axes. These remain early-stage programs without disclosed timelines, compound codes, or target indications. The strategic logic of starting in melanoma — a well-characterized ICI indication with biomarker infrastructure — is to generate proof-of-concept clinical data that de-risks the platform's expansion into those adjacent areas. For now, MBX-116 in melanoma is effectively the entire near-term clinical story.

As of 2026, mbiomics is a pre-clinical-stage company completing IND-enabling work. The immediate milestones are finalization of GMP manufacturing processes and submission of the pharmacological dataset required to open the Phase IB study, targeted for 2027. Series A proceeds are directly allocated to these activities. The Phase IB will evaluate safety and tolerability of MBX-116 in combination with checkpoint inhibitors in second-line advanced melanoma patients — the first human data the company will generate. A Series B raise would likely be timed around early Phase IB results.

The key watchpoints for mbiomics over the next 18-24 months include:

IND submission timing: any delay in GMP readiness or regulatory package completion pushes the 2027 Phase IB start and extends cash runway risk.
Phase IB safety profile: LBPs are generally well-tolerated, but dosing live bacteria to oncology patients on immunosuppressive regimens requires clean early safety data to maintain clinical momentum.
FMT competitor data: ongoing FMT-plus-ICI trials could read out positive data in melanoma before mbiomics reaches Phase IB, shifting the competitive and partnership landscape.
Partnership catalysts: a licensing or co-development deal with a pharma partner holding ICI assets would validate the platform and provide non-dilutive capital ahead of Phase II.

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