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。它是已知癌症中复发率最高的(80%)，是NHS治疗费用最高的癌症之一，费用为6500万GB pa(CRUK)。目前基于牛分枝杆菌(BCG)弱毒株的免疫治疗是一个重大挑战，对患者的生活质量和高癌症复发率有很大影响。此外，化疗和其他现有的免疫疗法有显著的副作用和一般较差的应答率。Prokaurum的疗法通过利用专利沙门氏菌菌株ZH9的自然肿瘤抑制特性来克服这些限制。Prokaurum先前已表明，与目前标准护理的BCG相比，ZH9在早期BC具有更好的疗效。这使得即将进行的第一项临床试验成为可能，Prokary与瑞士洛桑大学和诺维金尼公司合作，旨在通过探索ZH9在更先进的肌肉侵袭性BC(MIBC)中的疗效和作用机制，支持这项工作的进一步发展，ZH9既可以作为单独治疗，也可以与其他已获得许可或正在开发的BC疗法结合使用。

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.