FLachImmune: Innovative peptide-based approach to enhance anti-tumor immune response

Immune checkpoint inhibitors (ICI) have transformed the treatment of solid tumors, including melanoma. However, nearly half of patients either fail to respond or eventually develop resistance, and reliable predictive biomarkers of ICI response remain lacking.
Thus, there is an urgent need to improve the outcomes of ICI-based therapies in solid tumors, including melanoma, and to identify predictive biomarkers that enable better patient selection for immunotherapy.

Recently, the gut microbiota has emerged as a master modulator of the response to ICI, with studies demonstrating that patients who respond to ICI harbor a compositionally and functionally different gut microbiome compared to non-responding. While fecal microbiota transplantation is being explored in oncology patients, particularly those refractory to first-line ICIs, it faces significant challenges related to variability, engraftment, delivery, and safety.

FLachImmune peptides, derived from bacteria flagellin-related genes of Lachnospiraceae, are constitutively enriched in ICI- responding patients before starting the treatment 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. These findings have been validated in both in vitro and in vivo models, supporting their functional relevance and translational potential.

Applications:
- FLachImmune peptides as prognostic tool to determine ICI therapy response.
- FLachImmune peptides as therapy in combination with ICI in solid tumours.

Advantages:
-Culture-Free and 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.

Key Publications:
- Macadong AD et al. Cell Host Microbe. 2024. doi: 10.1016/j.chom.2024.10.006
- Ballerini M et al. Nat Biomed Eng. 2025.  doi: 10.1038/s41551-024-01318-z 

IP rights: PCT/EP2025/057375
Owners: IEO and Istituto Nazionale Tumori–IRCCS Fondazione G. Pascale