Sirnaomics and Innovent Entered Strategic Collaboration to Conduct Clinical Oncology Studies Combining STP705 and Sintilimab in the US

信达生物与圣诺达成战略合作,开展信迪利单抗联合RNAi疗法临床研究

2020-01-08 09:00:18 CISION

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 Sirnaomics Inc. , a leading biopharmaceutical company in discovery and development of RNAi therapeutics against cancer and fibrotic diseases, and Innovent Biologics, Inc. , a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, jointly announced today that the two companies have entered a strategic collaboration to conduct clinical studies, using Sirnaomics' RNAi drug candidate STP705 and Innovent's antibody drug Tyvyt® , for combination treatment in advanced cancers, such as Hepatocellular Carcinomas and Cholangiocarcinoma , with high unmet need in the US. Patrick Lu, PhD, President and Chief Executive Officer of Sirnaomics, stated, "This collaborative effort between Sirnaomics and Innovent will be the first example of a combination strategy using an RNAi drug candidate together with an approved immune checkpoint antibody drug for the treatment of liver cancers. This represents an important clinical approach for combating these deadly diseases where the silencing of gene targets that reduce T-cell access and activity may augment the activity of checkpoint inhibitors in liver cancer."  Michael Molyneaux, MD, Chief Medical Officer of Sirnaomics, stated, "Sirnaomics is very excited to enter into this collaboration agreement with Innovent to potentially bring lifesaving therapies to patients with Hepatocellular Cancers. It is well known that, despite recent advances in cancer therapies, HCC is still a deadly form of liver cancer with high unmet need. Our pre-clinical Proof of Concept oncology data has consistently demonstrated single agent efficacy with STP705 in HCC and our most recent work on mechanism of action strongly suggest that the use of our lead asset (STP705) in combination with antibody therapies could greatly benefit patients with HCC. Innovent has a very strong track record for innovation and execution in the clinical space and a shared vision of bringing lifesaving therapies to their patients. We believe that combining Sirnaomics novel siRNA technology with Innovent's cutting edge antibody therapies has the potential to significantly improve the current treatment landscape for patients with Hepatocellular Cancer." Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated, "Sintilimab has been granted marketing approval by the NMPA and is the only PD-1 inhibitor included in the NRDL. Sintilimab has gained broad recognition by the market, due to its profiles in safety and efficacy. Through partnership with other companies, we are exploring more sintilimab-based combination therapies and have seen some promising results. Developing a combination therapy, comprised of an antibody drug and a RNAi drug, may provide more comprehensive and effective treatments for patients. The potential clinical value of the combination therapy of sintilimab and cotsiranib will be evaluated and we hope more patients will benefit from this potential therapy globally." About STP705 (Cotsiranib)Sirnaomics' leading product candidate, STP705, is an siRNA (small interfering RNA) therapeutic which takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-β1 and COX-2 gene expression. The product candidate has received multiple IND approvals from both the US FDA and Chinese NMPA, including treatments of Cholangiocarcinoma, Non-Melanoma skin cancer and Hypertrophic Scar. STP705 has also received Orphan Drug Designation for treatment of Cholangiocarcinoma and Primary Sclerosing Cholangitis. STP705 has demonstrated a dramatic improvement in T-cell penetration into tumors in the liver with single agent action as well as improvement in the efficacy of an anti-PD-L1 antibody checkpoint inhibitor in an HCC model. This effect may improve other immune checkpoint inhibitor efficacies in addition to those targeting the PD-1/PD-L1 axis. About Tyvyt® (Sintilimab Injection)Tyvyt® (sintilimab injection), an innovative drug jointly developed in China by Innovent and Lilly, was granted marketing approval by the NMPA for r/r cHL in 2018, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology ("CSCO") for Lymphoid Malignancies. Tyvyt® (sintilimab injection) has been the only anti-PD-1 monoclonal antibody included in the NRDL since 2019. Tyvyt® (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for sintilimab injection to evaluate its safety and efficacy in a wide variety of cancer indications, including eight registration or pivotal clinical trials. Innovent is also conducting clinical studies of sintilimab injection in the United States. About Sirnaomics, Inc.Sirnaomics, Inc., a leading privately held biopharmaceutical company for discovery and development of RNAi therapeutics, is a Delaware corporation headquartered in Gaithersburg, Maryland, USA, with subsidiaries in Suzhou and Guangzhou, China. The company's mission is to develop novel therapeutics to alleviate human suffering and advance patient care in areas of high unmet medical need. The guiding principles of the company are: Innovation, Global Vision with a Patient Centered focus. Members of the senior management team have a great deal of combined experience in the biopharmaceutical industry, financial, clinical and business management in both the USA and China. The company is supported by funding from institutional investors and corporate partnerships. Sirnaomics has developed a strong portfolio of intellectual property with an enriched product pipeline. The therapeutic areas of focus include oncology and anti-fibrotic therapeutics. Learn more at www.sirnaomics.com. About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of oncology, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Since it was founded, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 21 innovative assets in the fields of oncology, autoimmune, metabolic diseases and other major therapeutic areas , with seventeen in clinical development, five in Phase III clinical trials, three NDAs under review by NMPA with priority review status, while Tyvyt®, officially approved for marketing in China in 2018, has been the only anti-PD-1 monoclonal antibody included in the NRDL since 2019. Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com. Contact:Sirnaomics, Inc. Michael Molyneaux, MD, MBA Chief Medical Officer michaelmolyneaux@sirnaomics.com Westwicke, an ICR Company Investors:Stephanie Carrington Stephanie.Carrington@icrinc.com +1 646 277 1282 Media: Mark Corbae Mark.Corbae@icrinc.com 203-682-8288 Innovent Biologics, Inc.Media:pr@innoventbio.com+86 512-6956 6088 Investors:ir@innoventbio.com+86 512-6956 6088 SOURCE Sirnaomics, Inc. Related Links http://www.sirnaomics.com
Sirnaomics Inc .,一家领先的生物制药公司,致力于发现和开发针对癌症和纤维疾病的 RNAi 疗法,以及开发和商业化治疗肿瘤、自身免疫、代谢等重大疾病的优质药物的国际一流生物制药公司 Innovate Biologics , Inc .;今天联合宣布,两家公司已进入战略合作,开展临床研究,使用 Sirnaomics 的 RNAi 候选药物 STP705和 Innovant 的抗体药物 Tyvyt ®,用于治疗晚期癌症,如肝癌和胆管癌,在美国的高需求未得到满足。 Sirnaomics 总裁兼首席执行官 Patrick Lu 博士说,“ Sirnaomics 和 Innovent 之间的这种合作将是第一个使用 RNAi 候选药物和批准的用于治疗肝癌的免疫检查点抗体药物的联合战略的例子。这是对抗这些致命疾病的重要临床方法,在这些疾病中,基因目标的沉默减少 T 细胞的进入和活动可能增加检查点抑制剂在肝癌的活动。”这是一个很好的例子 Sirnaomics 的首席医疗官 Michael Molynaux 医学博士说:“ Sirnaomics 非常高兴与 Innovant 达成合作协议,为肝癌患者提供挽救生命的治疗。众所周知,尽管最近在癌症治疗方面取得了一些进展,但肝癌仍然是一种致命的肝癌,其需求并未得到满足。我们的临床前概念肿瘤学证明数据一直显示单药效力与 STP705在肝癌和我们最近的工作机制的作用强烈建议使用我们的领先资产( STP705)结合抗体治疗可以大大有利于患者的 HCC 。Innovation 在临床领域的创新和执行方面有着非常强大的记录,并且有着为患者提供救生治疗的共同愿景。我们相信, Sirnaomics 新的 siRNA 技术与 Innovant 尖端抗体疗法相结合,有可能显著改善目前肝癌患者的治疗前景。 惠州博士,副总裁兼创新药物的肿瘤战略和医学科学负责人,表示,“ Sintilabma 已获得 NMPA 的上市许可,是唯一列入 NRDL 的 PD-1抑制剂。由于其在安全性和有效性方面的特点, Sintilabma 已得到市场的广泛认可。通过与其他公司的合作,我们正在探索更多基于烧结的联合疗法,并看到了一些有希望的结果。开发一种由抗体药物和 RNAi 药物组成的联合治疗方法,可以为患者提供更全面和有效的治疗方法。联合治疗的临床价值将被评估,我们希望更多的患者将受益于这种潜在的治疗。 关于 STP705(科西拉宁) Sirnaomics 的主要候选产品 STP705,是一种 siRNA (小干扰 RNA )疗法,利用双靶向抑制特性和多肽纳米颗粒( PNP )增强传递,直接降低 TGF-β1和 COX-2基因表达。该产品候选者已获得美国 FDA 和中国 NMPA 的多项 IND 批准,包括治疗胆管癌、非黑色素瘤皮肤癌和高营养 Scar 。STP705还接受孤儿药物指定用于治疗胆管癌和原发性硬化性胆管炎。STP705显示 T 细胞对肝脏肿瘤的渗透显著改善,具有单剂作用,并且在 HCC 模型中抗 PD-L1抗体检查点抑制剂的有效性得到改善。除了针对 PD-1/ PD-L1轴的免疫检查点抑制剂外,这种作用还可以提高其他免疫检查点抑制剂的效率。 关于 Tyvyt ®( Sintilumab 注射液) Tyvyt ®( siniliumab 注射液),一种由 Innovation 和礼来(Lilly)在中国联合开发的创新药物,于2018年获得 NMPA 对 r / r cHL 的上市许可,并纳入中国临床肿瘤学会( CSCO )关于淋巴瘤的2019年指南。Tyvyt ®(辛蒂利亚马注射液)是自2019年以来纳入 NRDL 的唯一抗 PD-1单克隆抗体。 Tyvyt ®(辛蒂利亚马注射液)是一种免疫球蛋白 G4单克隆抗体,与 T 细胞表面的 PD-1分子结合,阻断 PD-1/ PD-1配体-1( PD-L1)途径,激活 T 细胞杀死癌细胞。英诺珐公司目前正在进行20多项注射用辛替尼的临床研究,以评价其在多种癌症适应症上的安全性和有效性,包括8项注册或关键临床试验。英诺珐公司还在美国开展烧结瘤注射液的临床研究。 关于 Sirnaomics , Inc . Sirnaomics , Inc .是一家领先的私人控股生物制药公司,主要从事 RNAi 疗法的发现和开发,是一家总部位于美国马里兰州 Gaithersburg 的特拉华州公司,在中国苏州和广州设有子公司。公司的使命是开发新的治疗药物,以减轻人类的痛苦,并在高未得到满足的医疗需求领域推进病人护理。公司的指导原则是:创新,以病人为中心的全球视野。高级管理团队成员在美国和中国生物制药行业、财务、临床和业务管理等方面具有丰富的综合经验。公司由机构投资者和企业伙伴关系提供资金支持。Sirnaomics 开发了丰富的产品管道,拥有强大的知识产权组合。重点治疗领域包括肿瘤学和抗纤维疗法。详情请访问 www.sirnomics.com 。 关于“以诚信为起点,以行动取胜”的创新精神,创新的使命是开发和商业化普通百姓都能负担得起的优质生物制药产品。Innovation 成立于2011年,致力于研发、制造和商业化用于治疗肿瘤、自身免疫、代谢等重大疾病的优质创新药物。2018年10月31日, Innovation 在香港联合交易所有限公司主板上市,股票代码:01801。香港。 自成立以来, Innovation 已开发出包括研发、 CMC (化学、制造、控制)、临床开发和商业化能力在内的全集成平台。利用该平台,公司在肿瘤、自身免疫、代谢疾病等主要治疗领域构建了21项创新资产的稳健管线,其中临床开发17项,Ⅲ期临床试验5项, NMPA 正在审评的3项 NDA 具有优先审评地位,而 Tyvyt ®,2018年正式获准在中国上市,是自2019年以来纳入 NRDL 的唯一抗 PD-1单克隆抗体。 英诺泰在高端生物药物研发和商业化方面建立了一支国际先进人才队伍,其中不乏海外专家。公司还与礼来(Eli Lilly) and Company 、 Adimab 、因塞特(Incyte)、 Hanmi 等国际制药企业进行战略合作。英诺珐公司努力与各方共同努力,帮助推进我国生物制药产业,提高老百姓的药品可获得性,提升患者生活质量。如需更多信息,请访问: www.invenovitbtio.com 。 联系人: Sirnaomics , Inc . Michael Molynaux , MD , MBA 首席医疗官 michaelmoynaux @ sirnomics.com 投资 ICR 公司的 Westwicke : Stephanie Carrington Stephanie .Carrington @ icrinc.com +1646271282 Media : Mark Corbae Mark 。Corbae @ icrinc.com 203-682-8288 Innovative Biologics , Inc.Media : pr @ innvenovisio.com +86512-69566088 投资者: ir @ innven tbio.com +86512-69566088 SoURCE Sirnaomics , Inc . 相关链接 http://www.sirnomics.com

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