Nextbiotix

Exeliom Biosciences, formerly known as Nextbiotix, is a clinical-stage biopharmaceutical company focused on developing microbiome-based immunotherapies. Founded in December 2016 in Paris and Dijon, France, the company is built upon a decade of research into the gut microbiome. The scientific co-founders are internationally recognized experts in their fields: Professor Harry Sokol, a gastroenterologist; Dr. Philippe Langella, a research director in microbiology; and Professor Patrick Gervais, a specialist in process engineering. Their collective research, particularly on the commensal bacterium *Faecalibacterium prausnitzii*, identified its anti-inflammatory and immunomodulatory properties, which form the scientific bedrock of the company. Benjamin Hadida, who also co-founded the company and serves as CEO, brings entrepreneurial experience from investment banking, venture capital, and biotech operations.

The company's core business revolves around the research and development of Live Biotherapeutic Products (LBPs) to address unmet medical needs in immuno-oncology, inflammatory bowel diseases (IBD), and infectious diseases. The business model is centered on advancing drug candidates through rigorous clinical trials to eventually secure regulatory approval and commercialize these novel therapies, likely through licensing deals with larger pharmaceutical companies or direct sales. Exeliom operates within the human microbiome market, which is projected to grow substantially. Since its inception, the company has successfully raised a total of €24 million through a Series A funding round, completed in several stages between 2018 and 2023, with backing from investors like CE-Ventures, Auriga Partners, UI Investissement, and Biocodex.

Exeliom's lead product candidate is EXL01, a first-in-class, single-strain oral biotherapeutic containing a well-characterized, unmodified strain of *Faecalibacterium prausnitzii*. It is formulated in gastro-resistant capsules for targeted delivery in the intestines. The key mechanism of EXL01 involves activating the NOD2 pathway, a critical regulator of the immune system, to modulate immune responses. The company is pursuing a "pipeline-in-a-drug" strategy with EXL01, evaluating its efficacy across multiple diseases. As of early 2024, EXL01 is in Phase 2 clinical trials for treating Crohn's disease, recurrent *Clostridium difficile* infections, and as a combination therapy with immune checkpoint inhibitors for gastric cancer, non-small cell lung cancer, and hepatocellular carcinoma. By enhancing the body's immune response, EXL01 aims to improve the efficacy of standard-of-care treatments for these serious conditions.

Keywords: Exeliom Biosciences, Nextbiotix, microbiome therapy, immuno-oncology, immuno-inflammation, Faecalibacterium prausnitzii, EXL01, live biotherapeutic products, Crohn's disease, C. difficile infection, gastric cancer, lung cancer, hepatocellular carcinoma, NOD2 pathway, gut microbiota, clinical-stage biotech, Benjamin Hadida, Harry Sokol, Philippe Langella, Patrick Gervais, biopharmaceutical, immunotherapy, microbiome-based drugs