Pre-clinical development of a live biotherapeutic product engineered to remodel hyaluronic acid in solid tumours to enable checkpoint inhibitor efficacy

Neobe治疗公司是一家早期初创公司，正在开发一个合成生物学平台，使目前没有反应的癌症患者能够成功地进行免疫治疗。我们的平台是基于安全的肿瘤定植细菌菌株，这些细菌被设计成在实体肿瘤内被激活，以释放有效载荷，消除局部免疫渗透的障碍。通过增加能够穿透实体肿瘤并到达癌细胞的免疫细胞的数量，Neobe的产品可以指数级增加对现有免疫治疗方法有反应的患者数量，而不会影响健康组织。该项目专门专注于Neobe领先产品的临床前开发。虽然内部数据包括产品在体外环境下的疗效，但该项目将包括在不同体内癌症模型中的疗效研究，展示我们的产品在目前对这些策略无效的两种不同适应症中实现免疫治疗功效的潜力。将设计更多的功能，以加强我们产品的安全性，这已被确定为进一步资助和与制药合作伙伴开发组合战略的关键一步。该项目的主要成果将是在多种活体模型中提供强大的疗效、药理和安全性数据包，这将为我们产品的临床开发开辟道路。与监管机构的初步会议澄清了临床开发管道，为项目完成后人类临床试验的第一开辟了道路。它还将使对该公司的进一步投资成为可能，推动该公司朝着开发针对不同疾病指征的更多基质重塑产品的方向发展。该项目将由Neobe的团队领导和主要执行，由于其在细菌工程、癌症生物学和治疗商业化方面的联合专业知识，该团队非常适合确保其成功。它的成功将成为为癌症患者开发一流工程治疗产品的重要垫脚石。这可能会对癌症患者的生活产生重大影响，将免疫疗法的巨大治疗益处扩大到无反应者。它还将有助于英国崛起为使用合成生物学来生产更安全、更有效的治疗产品的领先者。

Neobe Therapeutics is an early-stage start up developing a synthetic biology platform to enable immunotherapy success in currently non responding cancer patients. Our platform is based on safe strains of tumour colonizing bacteria, which are engineered to be activated within solid tumours to release payloads which remove local barriers to immune infiltration. By increasing the number of immune cells that are able to penetrate solid tumours and reach cancer cells, Neobe's products can exponentially increase the number of patients that respond to existing immunotherapeutic approaches, without affecting healthy tissues.This project is specifically focused on the pre-clinical development of Neobe's lead product. While internal data includes product efficacy in _in vitro_ settings, this project will include efficacy studies in different _in vivo_ cancer models, demonstrating our product's potential to enable immunotherapy efficacy in two different indications that currently don't respond to these strategies. Additional features will be engineered to strengthen the safety profile of our product, which has been identified as an essential step towards further funding and the development of combination strategies with pharmaceutical partners. The main outcome of the project will be a strong efficacy, pharmacological and safety data package in multiple in vivo models, which will open the way for the clinical development of our product. Initial meetings with regulators with clarify the clinical development pipeline, opening the way to first in human clinical trials post project completion. It will also enable further investment into the company, fuelling its growth towards the development of additional stromal remodelling products targeting different disease indications.The project will be led and largely performed by Neobe's team, which is uniquely suited to guarantee its success due to its joint expertise in bacterial engineering, cancer biology and therapeutic commercialization. Its success will be an important stepping stone in the development of a first in class engineered therapeutic product for cancer patients. This could have significant impact in the lives of cancer patients, by expanding the tremendous therapeutic benefits of immunotherapies to non-responders. It will also contribute to the rise of the UK as a leader in the use of synthetic biology to generate safer and more effective therapeutic products.