FLach Immune - Innovative peptide-based approach to enhance anti-tumor immune response

State of the art
Immune checkpoint inhibitors (ICI) can cure advanced melanoma, but about half of patients do not respond to the treatment. Recently, the gut microbiota has emerged as a master modulator of the response to ICI and we and other groups showed that patients responding to ICI bear a compositionally and functionally different gut microbiome from non-responding patients. Currently, fecal microbiota transplant is being tested on oncologic patients undergoing ICI, especially those refractories in firstline. However, it has many hurdles related to variability, engraftment, delivery and safety.

Medical Need
There is an urgent need of improving the outcome of ICI-based therapies in solid tumors, including melanoma. Many patients fail to respond to ICIs or develop resistance over time, highlighting the necessity for interventions that prime and sustain immune activation. Additionally, there is a lack of reliable predictive biomarkers to determine which patients will respond well to immunotherapy.

Solution
FLachImmune peptides derive from bacteria flagellin-related genes of Lachnospiraceae. These peptides are constitutively enriched in patients responding to ICI and play a key role in priming antitumor immunity by mimicking tumor associated antigens. FLachImmune peptides can induce antigen-specific CD8+ T cell reactivity, enhance tumor-infiltrating lymphocytes' expansion and their antitumor activity.

Applications & Advantages
- FLachImmune peptides as prognostic tool to determine ICI therapy response
- FLachImmune peptides as therapy in combination with ICI
- Culture-Free & No Live Biotherapy, increasing safety and simplifying implementation
- Manufacturing Excellence offering high yield, rapid production, low costs and clinical-grade quality, with versatility for both peptide- and mRNA-based applications.
- Flexible Proprietary Platform with optimized pipelines, combination of dry & wet lab expertise potential application to other cancer indications easy integration into clinical workflows.**_

IP asset_**
Patent application PCT/EP2025/057375 co-owned by Istituto Europeo di Oncologia and Istituto Nazionale Tumori–IRCCS Fondazione G. Pascale

References
Macadong et al. Cell Host & Microbe 2024; Ballerini et al. Nat. Biomed. Eng. 2025