StimOxyGen - pH-responsive, oxygen-generating nanoparticles for enhanced treatment of hypoxic tumours

癌症发病率和死亡率持续上升; 2000年有30%的人被诊断患有癌症，这一统计数据在2020年已增加到40%。尽管癌症患病率增加，但癌症治疗的主要方法在很大程度上保持不变，即，手术（如果符合条件）、化疗和放疗，根据管辖范围，高达50%的癌症患者接受放疗。许多这些治疗由于肿瘤缺氧（肿瘤部位缺氧）而失败。缺氧是成功治疗癌症的重大挑战，因为几乎所有实体瘤都在某种程度上缺氧。放射治疗在缺氧肿瘤中的有效性降低250-300%，并且解决缺氧带来的挑战代表了一个主要的临床未满足的需求，因为50%的癌症患者接受放射治疗。自20世纪初以来，人们就认识到了这一重要的癌症治疗障碍，但到目前为止，由于各种原因，包括毒性和缺乏有效性等，克服缺氧的尝试都被证明是不成功的。StimOxyGen是一种专有的创新纳米颗粒解决方案，可以解决缺氧对有效放疗的挑战，可以与当前的临床实践无缝集成。肿瘤中缺氧的后果之一是肿瘤微环境中pH值降低。新型StimOxyGen制剂由一种产氧纳米颗粒组成，该纳米颗粒涂有pH敏感聚合物。该项目的目的是加速OxyStimGen的发展，使其成为第一个人体临床试验，以加强现有的基于放射治疗的癌症治疗方法，并进入估计为69亿美元的全球市场。在此过程中，该项目将实现一系列技术和商业里程碑，以解决财务、监管和商业问题，从而能够及时地对该技术进行充分的商业利用。

Cancer incidence and mortality continues to rise; with 30% of people diagnosed with cancer in 2000, this statistic has increased to 40% in 2020\. Despite increasing cancer prevalence, the major approaches to cancer treatment have largely remained the same i.e., surgery (if eligible), chemotherapy, and radiotherapy and depending on the jurisdiction up to 50% of cancer patients receive radiotherapy. Many of these treatments fail due to tumour hypoxia (a lack of oxygen at the tumour site).Hypoxia is a significant challenge to the successful treatment of cancer as virtually all solid tumours are hypoxic to some degree. Radiotherapy is 250-300% less effective in hypoxic tumours and addressing the challenge presented by hypoxia represents a major clinical unmet need as 50% of cancer patients receive radiotherapy. This important barrier to successful cancer treatment has been recognised since the early 1900s but up to now, attempts to overcome hypoxia have proven unsuccessful for a variety of reasons including toxicity and a lack of proven efficacy of such approaches.StimOxyGen is a proprietary and innovative nanoparticle-based solution to the challenge presented by hypoxia to effective radiotherapy that can seamlessly integrate with current clinical practice. One of the consequences of hypoxia in the tumour is a decreased pH in the tumour microenvironment. The novel StimOxyGen formulation consists of an oxygen-generating nanoparticle that is coated with a pH sensitive polymer. Once the particle encounters the low pH in the tumour microenvironment, the polymer dissolves and oxygen is then generated in the actual tumour.The purpose of this project is to accelerate the development of StimOxyGen towards a first in human clinical trial in order to enhance existing radiotherapy-based approaches to cancer treatment and access a global market estimated to be in the region of US$6.9 billion. In doing so the project will achieve a series of technological and commercial milestones in order to address financial, regulatory and commercial requisites to enable full commercial exploitation of the technology in a timely manner.