Synlogic and Roche Partner for Immuno-Oncology Combination Therapy for Solid Tumors

英国生物公司Synlogic和罗氏合作开发晚期实体肿瘤联合治疗方案

2019-05-23 18:00:00 BioSpace

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Cambridge, Mass.-based Synlogic is partnering with Roche to develop Synlogic’s SYNB1891 with Roche’s checkpoint inhibitor Tecentriq (atezolizumab) in advanced solid tumors. Synlogic plans to file an Investigational New Drug (IND) with the U.S. Food and Drug Administration (FDA) in the second half of this year. SYNB1891 is a non-pathogenic strain of the bacterium E. coli that has been engineered to express a Stimulator of Interferon Genes (STING) agonist, which stimulates the innate immune system. When bacteria are enveloped by antigen-presenting cells within a tumor, the STING pathway is activated, which results in a type 1 interferon (IFN) response and the beginning of tumor-specific T-cell responses. In other words, it stimulates the immune system. Also, the bacterial framework used in Synlogic’s Synthetic Biotic platform stimulates the innate immune system via other mechanisms, including Toll-like receptors. This may increase the magnitude of the overall immune response. “This collaboration is an important step in advancing SYNB1891 as a potential treatment for difficult to treat cancers at it provides us with access to an important checkpoint inhibitor, atezolizumab, while allowing us to maintain ownership of our novel development candidate,” said Aoife Brennan, Synlogic’s president and chief executive officer. “We believe that SYNB1891 has potential to offer a new and meaningful approach in the fight against cancer when used in combination with checkpoint inhibitors, by potentially enhancing their potency and effectiveness.” Synlogic expects to launch a Phase I clinical trial of SYNB1891 in advanced/metastatic solid tumors. That trial will evaluate the safety and tolerability of the drug to determine maximum tolerated doses for it as a monotherapy and the recommended Phase II dose in combination with Tecentriq. At the company’s first-quarter financial report on May 9, Synlogic provided a pipeline update, including a presentation of its SYNB1618 for phenylketonuria (PKU), publication in Science Translational Medicine of first-in-human clinical data of SYNB1020 in cirrhosis and elevated blood ammonia, in-house manufacturing of SYNB1891, and lead optimization of investigational Synthetic Biotic medicines with AbbVie for inflammatory bowel disease. The company also reported a consolidated net loss of $12.9 million for the quarter, with R&D expenses of $10.4 million. This was an increase from $8.4 million for the same period in 2018, primarily due to an increase in compensation-related expenses tied to increased headcount and increased manufacturing and preclinical and clinical studies. Revenue was $0.3 million for the quarter associated with its collaboration with AbbVie. As of March 31, 2019, the company had cash, cash equivalents, and short-term investments of $109.8 million. At the quarterly report, Brennan stated, “We made significant progress on our 2019 goals in the first quarter of the year providing a strong foundation for the continued development of our Synthetic Biotic platform and clinical pipeline.” He added, “We strengthened our scientific leadership with the appointment of two experienced drug developers, Dr. Scott Plevy, as chief scientific officer, and Dr. Patricia Hurter, who joined our board of directors and brings additional relevant experience in manufacturing.” Plevy was most recently vice president, Gastroenterology Disease Area Leader and IL-23 Pathway Leader at Janssen Research & Development, a Johnson & Johnson company. Nurter was senior vice president of Vertex from 2011 to 2019.
马萨诸塞州剑桥市.基于 Synlogic 的公司正在与罗氏公司合作开发 Synlogic 的 SYNB1891,该公司与罗氏(Roche)公司的检查点抑制剂 Tecentriq (atezolizumab)合作开发先进的实体肿瘤。 Synlogic 计划在今年下半年向美国食品和药物管理局( FDA )提交一份调查新药( IND )。SYNB1891是大肠杆菌的一种非致病性菌株,已被设计成表达干扰素基因( STING )激动剂的刺激物,刺激先天免疫系统。当细菌被肿瘤内的抗原提呈细胞包围时, STING 通路被激活,从而导致1型干扰素( IFN )反应和肿瘤特异性 T 细胞反应的开始。换句话说,它刺激免疫系统。 此外, Synlogic 合成生物平台中使用的细菌框架通过其他机制刺激先天免疫系统,包括 Toll 样受体。这可能会增加整体免疫反应的程度。 Synlogic 总裁兼首席执行官奥伊夫•布伦南( Aife Brennan )表示:“这一合作是推进 SYNB1891成为一种潜在的治疗癌症的方法的重要一步,它为我们提供了一个重要的检查点抑制剂 atezolizumab ,同时使我们能够保持对我们新的开发候选人的所有权。”“我们相信 SYNB1891有潜力通过潜在的提高其效力和效力,在与检查点抑制剂联合使用时,提供一种新的、有意义的对抗癌症的方法。” Synlogic 预计将启动 SYNB1891在晚期/转移性实体肿瘤的 I 期临床试验。该试验将评估药物的安全性和耐受性,以确定最大耐受剂量为单一疗法和推荐的第二期剂量与 Tecentriq 联合使用。 在5月9日的公司第一季度财务报告中, Synlogic 提供了一份管道更新,包括其 SYNB1618用于苯酮尿症( PKU ),发表在《科学转化医学》上的 SYNB1020在肝硬化和血氨升高方面的首次人体临床数据,以及 SYNB1891的内部制造。以艾伯维(AbbVie)为研究对象的炎症性肠病合成生物药物的优化研究。 该公司还报告本季度合并净亏损1290万美元,研发支出1040万美元。这与2018年同期的840万美元相比有所增加,主要是由于与增加员工人数和增加制造及临床前和临床研究相关的补偿相关费用增加所致。该季度与艾伯维(AbbVie)的合作收入为30万美元。 截至2019年3月31日,公司拥有现金、现金等价物、短期投资10,980万元。 在季度报告中, Brennan 表示,“我们在今年第一季度的2019年目标上取得了重大进展,为我们合成生物平台和临床管道的持续发展提供了坚实的基础。” 他补充说,“我们通过任命两位经验丰富的药物研发人员——首席科学官斯科特·普列维博士和帕特里夏·赫斯特博士( PatriciaHutter )来加强我们的科学领导能力,他们加入了我们的董事会,在制造领域带来了更多的相关经验。” 普莱维最近是强生公司杨森(Janssen) Research & Development 副总裁、胃肠病领域负责人和 IL-23病理科负责人。Nuter 曾于2011年至2019年担任福泰(Vertex)高级副总裁。

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