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The Science behind our therapy

Recent technological advances in biomedical research have contributed to characterising the human microbiome and uncovering its vital role in health and disease. In this line, we identified specific strains of bacteria that are less abundant in colorectal cancer patients compared to healthy individuals. In pre-clinical animal experiments, we found that supplementation with those bacteria is sufficient to trigger an anti-tumor immune response in colorectal cancer, as well as in melanoma, breast and lung cancer. Our results show enhanced immune cell activation and infiltration into the tumor when the bacteria are applied. This way, we aim to circumvent the problem of current immunotherapies, by which tumors with low immune-cell infiltration cannot be effectively treated

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Improving patients´ quality of life and treatment outcome

3

projects in our pipeline

7

different animal models responding to our lead therapy

780' 000

patients could benefit from our therapy each year

Our novel therapeutic approach is purely based on commensal bacteria that are abundantly present in healthy individuals. This therapy aims to regenerate the intestinal microbiota composition of cancer patients and to reinforce the anti-tumor immune response. As a result, we expect the supplementation with these bacteria to be very safe and highly tolerable. Our therapeutic approach, therefore, offers an immense advantage compared to current anti-tumor therapies with their detrimental side effects. Moreover, these characteristics qualify our bacterial therapy to be used to both treat and prevent cancer. Our bacteria will be applied in lyophilized form packed in pH-resistant capsules as an oral therapy, requiring less visits to the hospital since the administration is easier and faster than current therapies. For these reasons, we are convinced that our bacteria-based treatment will not only enhance treatment efficacy but also improve quality-of-life of cancer patients.

Recolony’s pipeline

Our oncology focused pipeline based on microbes and microbial-derived products

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The rapid advancement of these potential biotherapeutics will enable Recolony to address serious medical needs in malignant diseases.

Recolony’s pipeline includes its lead program in colorectal cancer (CRC), which has demonstrated proof of concept efficacy in in vivo models and plans to start a First-in-Human Phase Ib study in the second half of 2025. Additionally based on promising pre-clinical results, we aim to expand our lead novel drug candidates to other types of solid tumors. Our growing R&D program is also working with microbial-derived products that have shown to potently activate the anti-tumor immune response in different tumor models in vivo. Further, we identified another microbial-derived product that has potential to act as a biomarker for early detection of CRC and therapy efficacy, which we included in our pre-clinical development program.

Publications

Commensal Clostridiales strains mediate effective anti-cancer immune response against solid tumors

Together we succeed

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