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Cell based cancer vaccines: regulatory and commercial development

机译：基于细胞的癌症疫苗：监管和商业发展

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There is both clinical and regulatory drive to expedite development of safe, efficacious cancer therapies. Stimulation of the patients immune system through vaccination with tumour cells has long been at the vanguard of cancer therapeutic vaccines, and several have been demonstrated to be safe and to have efficacy in early clinical trials for a range of cancers including melanoma, renal cell carcinoma, prostate and colorectal cancers. A number of development-stage vaccines and strategies are currently being tested, utilising either autologous or allogeneic tumour cells, which may also have been ex vivo manipulated (e.g. cytokine transfected cells). It seems likely that clinical trial success, and hence patient benefit, could be improved through better patient identification, possibly by the discovery and use of novel immune response biomarkers. In this review, we aim to summarise the state of tumour cell vaccines in commercial development and to explore not only the difficulties of determining efficacy, but also the production challenges faced when developing a vaccine from proof of principle to pivotal phase III trials.
机译：在临床和法规上都有驱动力，以加快安全，有效的癌症治疗的发展。长期以来，通过接种肿瘤细胞来刺激患者的免疫系统一直是癌症治疗疫苗的先锋，并且已经证明其中几种是安全的，并且在包括黑色素瘤，肾细胞癌，前列腺癌和大肠癌。目前正在利用自体或同种异体肿瘤细胞对许多处于发展阶段的疫苗和策略进行测试，这些肿瘤细胞也可能已经进行了离体操作（例如细胞因子转染的细胞）。似乎可以通过更好的患者识别（可能是通过发现和使用新型免疫反应生物标记物）来提高临床试验的成功率，从而改善患者的利益。在这篇综述中，我们旨在总结肿瘤细胞疫苗在商业开发中的状态，不仅探讨确定功效的困难，而且探讨从原理证明到关键的III期临床试验开发疫苗时面临的生产挑战。

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