Development of a comprehensive microbial immunotherapy platform with immuno-transcriptomic monitoring for treatment of bladder cancer (DOCMI-BC)

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Bladder Cancer (BC) affects more than 550,000 people globally every year. With the highest recurrence rate of any known cancer (80%), it is one of the most expensive for the NHS to treat, costing £65M pa (CRUK). Current immunotherapy treatments based on the weakened strain of _Mycobacterium bovis_ (BCG) present a significant challenge, with substantial impact on patient quality of life and high rates of cancer recurrence. Moreover, chemotherapy and other existing immunotherapies have significant side effects and generally poor response rates.Prokarium's therapeutics are positioned to overcome such limitations by leveraging the natural tumor-suppressive properties of proprietary _Salmonella_ bacteria strain ZH9\.Prokarium have previously shown that ZH9 has superior effectiveness compared to the current standard-of-care BCG in early-stage BC. This has enabled an upcoming first clinical trial and, in collaboration with Switzerland based University of Lausanne and Novigenix, Prokarium aims to expand upon this work to support the further development of ZH9 for BC by exploring the efficacy and mechanism of action of ZH9 in more advanced muscle invasive BC (MIBC), both as a standalone treatment and when administered in combination with other therapies, either already licensed or in development for BC.The incorporation of Novigenix technology will allow understanding of the mechanism of action of the therapy and identification of biomarkers of response that can be used to improve future clinical trials and ultimately provide better treatments to BC patients.