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。它是所有已知癌症中复发率最高的（80%），也是NHS最昂贵的治疗之一，每年花费6500万英镑（CRUK）。目前基于牛分枝杆菌（BCG）弱毒株的免疫治疗提出了重大挑战，对患者的生活质量产生了重大影响，并且癌症复发率很高。此外，化疗和其他现有的免疫疗法有明显的副作用，通常反应率很差。Prokarium公司的治疗方法是利用其专有的沙门氏菌菌株ZH9的天然肿瘤抑制特性来克服这些限制。Prokarium先前的研究表明，在早期BC中，与目前的标准治疗卡介苗相比，ZH9具有更好的疗效。这使得即将进行的首次临床试验成为可能，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在更晚期肌肉浸润性BC （MIBC）中的疗效和作用机制，支持ZH9用于BC的进一步开发，无论是作为单独治疗还是与其他治疗联合使用，无论是已经获得许可的还是正在开发的BC。Novigenix技术的结合将有助于了解治疗的作用机制和生物标志物的识别，这些生物标志物可用于改进未来的临床试验，并最终为BC患者提供更好的治疗。

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.