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

膀胱癌（BC）每年影响全球超过55万人。由于任何已知癌症的复发率最高（80%），它是NHS治疗费用最高的癌症之一，每年花费6500万英镑（CRUK）。目前基于牛分枝杆菌（BCG）减毒株的免疫治疗提出了一个重大挑战，对患者的生活质量和癌症复发率产生了重大影响。此外，化疗和其他现有的免疫疗法有显着的副作用和反应率普遍较低。Prokarium的治疗定位，以克服这些限制，通过利用专有_沙门氏菌_细菌菌株ZH9\的天然肿瘤抑制特性。Prokarium先前已经表明，ZH9具有上级的有效性相比，目前的标准护理BCG在早期BC。这使得即将进行的第一项临床试验成为可能，Prokarium与瑞士洛桑大学和Novigenix合作，旨在扩大这项工作，通过探索ZH9在更晚期肌肉侵入性BC（MIBC）中的疗效和作用机制，支持ZH9用于BC的进一步开发，无论是作为独立治疗还是与其他治疗联合使用，Novigenix技术的引入将允许理解治疗的作用机制并鉴定可用于改善未来临床试验并最终为BC患者提供更好治疗的反应生物标志物。

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.