I-Mab Biopharma and Junshi Biosciences Announce Collaboration to Evaluate TJD5 in Combination with Toripalimab for the Treatment of Patients with Cancers in China

天境生物与上海君实生物合作,评估TJD5联合toripalimab治疗多种癌症

2019-09-11 13:00:00 BioSpace

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I-Mab Biopharma , a China and U.S.-based clinical stage biopharmaceutical company exclusively focused on the discovery and development of potential first-in-class and best-in-class biologics in immuno-oncology and autoimmune diseases announces the signing of a collaboration agreement with Shanghai Junshi Biosciences Co., Ltd , an innovation-driven biopharmaceutical company to evaluate the combination therapy of I-Mab's TJD5, a proprietary innovative CD73 antibody with Junshi Biosciences' Toripalimab , a recombinant humanized anti-PD-1 monoclonal antibody in patients with cancers in China. Dr. Jingwu Zang, Founder and Chairman of I-Mab, commented, "TJD5 is an innovative CD73 antibody with best-in-class potential that has entered into Phase I trial in the US. We are very pleased to collaborate with Junshi to explore the clinical synergies with Toripalimab which is an innovative drug with distinctive treatment advantages. We are looking forward to bringing more clinical benefits to patients across various cancer types." Dr. Ning Li, CEO of Junshi Biosciences, commented, "As an anti multi-tumor drug, toripalimab has shown good safety and efficacy in clinical trials with mono and combination therapy. We believe, through the cooperation with I-Mab, we could continue to explore the combination potential of toripalimab and innovative drugs to improve the outcomes of immune-oncology therapy, lightening hope for more patients. About TJD5: TJD5 is a novel and differentiated blocking antibody against CD73, a surface enzyme on stromal cells and cancer cells responsible for the production of adenosine, which is highly immunosuppressive. It is expected to stimulate the immunosuppressive tumor micro-environment and to work in concert with other cancer therapies such as PD-1 and PD-L1 antibodies. TJD5 is in a Phase 1 clinical trial in the US, it is a proprietary innovative CD73 monoclonal antibody from I-Mab's discovery pipeline with best-in-class potential. About Toripalimab (JS001, Trade name: Tuoyi) Toripalimab. a recombinant humanized anti-PD-1 monoclonal antibody for injection is the first domestic-developed anti-PD-1 mAb granted marketing approval in China, supported by National Science and Technology Major Project. In March 2018, its New Drug Application ("NDA") was accepted by the NMPA and put into prioritized evaluation and approval process. On Dec 2018, Toripalimab was conditionally granted marketing approval for use in the treatment of unresectable or metastatic melanoma that has failed previous systemic therapy by the NMPA, which is the first commercialized product of Junshi Biosciences. In the pivotal clinical trial, patients were observed with the ORR of 17.3% and the DCR of 57.5%, and the one-year overall survival rate is 69.3%. The NDA approval of toripalimab witnessed the pivotal step from pre-revenue biotech start-up to a commercial-stage biopharmaceutical company. Since Toripalimab started its clinical trials at the beginning of 2016, over 30 trials have been conducted in China, the US and other countries, covering 14 kinds of tumors, i.e. NPC, UC, lung cancer, EC, HCC, TNBC, etc. Cooperations with domestic and overseas innovation pharma companies on combination therapy are also under exploration. About I-Mab: I-Mab is a dynamic and fast-growing global biotech company exclusively focused on developing biologics of first-in-class or best-in-class potential in the therapeutic areas of immuno-oncology and autoimmune diseases. I-Mab's mission is to bring transformational medicines to patients through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-PoC (Proof-of-Concept) and Fast-to-Market development strategies through internal R&D and global partnerships. The Company is on track to become a fully integrated end-to-end global biopharmaceutical company with cutting-edge discovery platforms, proven preclinical and clinical development expertise, and world-class GMP manufacturing capabilities. I-Mab is well-recognized by capital markets to have successfully raised over US$400 million in equity financing since its establishment in 2016. Its recent USD 200 million Series C financing represents one of the largest amounts ever raised by a biotech company in China. For more information, please visit the Company's website at www.i-mabbiopharma.com. About Junshi Biosciences: Junshi Biosciences (NEEQ:833330; HKEX:1877) was founded in December 2012 by a team graduated from renown universities in China and the United States with extensive experience in the industry and international transfer of technology. Junshi Biosciences is mainly engaged in the research and development of therapeutic antibody. The company specializes in the R&D and industrialization of innovative monoclonal antibody drugs and other therapeutic proteins (TPs) drugs. With an impressive product pipeline including 17 innovative drugs and 2 biosimilars, Junshi Biosciences is the first Chinese company to have filed investigational new drug application (IND) and new drug application (NDA) for anti-PD-1 monoclonal antibody to National Medical Products Administration (NMPA). The company is also the first domestic company to have obtained approval for IND application for anti-PCSK9 monoclonal antibody and anti-BLyS monoclonal antibody from NMPA. In April, the company obtained IND approval from the US FDA for first-in-human anti-BTLA monoclonal antibody for tumor. Junshi Biosciences has more than 1000 employees around the world, in Los Angeles and Maryland in the United States, and Shanghai, Suzhou, Beijing and Guangzhou in China.
天境生物科技,一家专注于发现和开发免疫肿瘤学和自身免疫性疾病中潜在的一流和一流生物制剂的中美临床阶段生物制药公司,宣布与上海君实生物医药签署合作协议。上海君实生物医药是一家创新驱动的生物制药公司,旨在评估天境生物的tjd5,一种与君实生物的toripalimab,一种重组人源化抗pd-1单克隆抗体在中国癌症患者中的联合治疗。 天境生物科技的创始人兼主席臧景武博士评论道:“tjd5是一种创新的cd73抗体,具有同类最佳的潜能,已经进入美国的一期试验。我们很高兴与君实生物合作,探索与具有独特治疗优势的创新药物toripalimab的临床协同作用。我们期待着为不同癌症类型的患者带来更多的临床益处。” 君实生物首席执行官李宁博士评价道:“托利帕利单抗作为一种抗多肿瘤药物,在单药和联合治疗的临床试验中显示出良好的安全性和有效性。我们相信,通过与天境生物的合作,我们可以继续探索toripalimab与创新药物的结合潜力,以提高免疫肿瘤治疗的效果,为更多的患者带来希望。 关于TJD5: tjd5是一种新的、分化的抗cd73的封闭性抗体,cd73是基质细胞和癌细胞表面的一种酶,负责产生具有高度免疫抑制作用的腺苷。它有望刺激免疫抑制的肿瘤微环境,并与其他癌症治疗如pd-1和pd-l1抗体协同工作。TJD5正在美国进行一期临床试验,它是一种专利的创新型CD73单克隆抗体,来自I-MAB的发现管道,具有同类最佳的潜力。 关于toripalimab(js001,商品名:tuoyi) 托里帕利马布。注射用重组人源化抗pd-1单克隆抗体是我国首个获得国家科技重大专项资助的国产抗pd-1单克隆抗体。2018年3月,其新药申请(“NDA”)被NMPA接受,并进入优先评估和批准程序。2018年12月,toripalimab获得市场批准,用于治疗之前未通过nmpa系统治疗的不可切除或转移性黑色素瘤,nmpa是君石生物科学的首个商业化产品。在关键的临床试验中,观察到患者的orr为17.3%,dcr为57.5%,一年总生存率为69.3%。toripalimab的nda批准见证了从创收前的生物技术初创公司到商业阶段的生物制药公司的关键一步。 自2016年初toripalimab开始临床试验以来,已在中国、美国和其他国家进行了30多个试验,涉及14种肿瘤,包括npc、uc、肺癌、ec、hcc、tnbc等,并与国内外创新制药公司就combina进行了合作。动作疗法也在探索中。 关于i-MaB: i-mab是一家充满活力和快速发展的全球生物技术公司,专门致力于在免疫肿瘤和自身免疫疾病治疗领域开发具有一流或一流潜力的生物制剂。i-mab的使命是通过创新为患者带来转型药物。i-mab的10多种临床和临床前阶段候选药物的创新渠道是由公司的快速poc(概念证明)和快速市场开发战略通过内部研发和全球合作推动的。该公司有望成为一家完全整合的端到端全球生物制药公司,拥有尖端的发现平台、经验证的临床前和临床开发专业知识以及世界级的gmp制造能力。I-MAB自2016年成立以来,已成功筹集超过4亿美元的股权融资,受到资本市场的广泛认可。其最近2亿美元的C系列融资是中国生物技术公司有史以来筹集的最大金额之一。有关更多信息,请访问公司网站www.i-mabbiopharma.com。 关于君石生物科学: 俊时生物科学(NEEQ:833330;港交所:1877)由一支毕业于中美两国知名大学、在行业和国际技术转让方面拥有丰富经验的团队于2012年12月创立。 君石生物科学主要从事治疗性抗体的研究和开发。公司专业从事创新型单克隆抗体药物和其他治疗蛋白(tps)药物的研发和产业化。君氏生物科技拥有17种创新药物和2种生物仿制药,是中国第一家向国家药品监督管理局提交抗PD-1单克隆抗体研究新药申请(IND)和新药申请(NDA)的公司。(NMPA)。该公司也是国内第一家从NMPA获得抗PCSK9单克隆抗体和抗BLYS单克隆抗体IND申请批准的公司。今年4月,该公司获得了美国食品和药物管理局(fda)的ind批准,获得了首个抗人btla肿瘤单克隆抗体。俊石生物科学在全球拥有1000多名员工,在美国的洛杉矶和马里兰州,在中国的上海、苏州、北京和广州。

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