Recolony is focusing on the development of a bacteria-based therapy for colorectal cancer that consists primarily of selected bacteria of the gut microbiota. These bacteria have an enormous impact on the immune system and are able to provoke and enhance an immune reaction to fight cancer. The bacteria will be orally administered in gastro-resistant capsules with colonic release. With this approach, Recolony aims to develop a new class of drugs for the treatment and prevention of cancer.
Colorectal cancer is the third most prevalent cancer and the second leading cause of cancer mortality worldwide. In advanced stages, 5-year survival rates are below 15%. While current immunotherapies have been shown to be effective in certain cancers, they usually fail in patients with advanced colorectal cancer, with a response rate of only 3-6%.
Recent technological advances in biomedical research have contributed to characterizing the human microbiome and offer the potential to monitor, prevent, or even cure human disease through specific microbiota interventions. Targeted modifications of the gut microbiota have few or no side effects and the potential to dramatically improve therapeutic outcomes as well as the quality of life of cancer patients under treatment. The Recolony team identified specific strains of bacteria that are less abundant in individuals with colorectal cancer compared with people who do not have that type of cancer. In pre-clinical experiments, it was found that supplementation with those bacteria was sufficient to trigger an anti-tumor immune response in colorectal cancer as well as in melanoma, breast cancer, and lung cancer. The results showed enhanced immune cell activation and infiltration into the tumor when the bacteria were orally administered. By translating this approach into the clinic, Recolony aims to circumvent the problem of current immunotherapies, which are unable to treat tumors with low immune cell infiltration effectively.
The Recolony team aims to develop a live biotherapeutic product based on proprietary bacterial strains and to conduct a Phase I clinical trial targeting colorectal cancer. The team plans to produce the bacteria in lyophilized form, packed in pH-resistant capsules, and to obtain regulatory approval for a first-in-human trial. Recolony’s goal is to shift the paradigm of cancer treatment away from single-target drugs towards a gut microbiota-guided activation of the immune system.