Yiviva宣布在第一线YIV-906联合索拉非尼联合疗法治疗肝细胞癌

StephenW

Yiviva Announces Dosing of First Patient in Phase 2b Study of First-Line YIV-906 Plus Sorafenib Combination Therapy in the Treatment of Hepatocellular Carcinoma
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April 06, 2020 07:00 ET | Source: Yiviva
multilang-release

- First-in-class oncology therapeutic candidate YIV-906 applies an integrative systems biology approach -
- Global study to evaluate efficacy, safety, and quality of life in patients with hepatitis B-positive hepatocellular carcinoma -

NEW YORK and SHANGHAI, China, April 06, 2020 (GLOBE NEWSWIRE) -- Yiviva today announced that the first patient has been dosed in a Phase 2b study of YIV-906 in combination with sorafenib in the treatment of patients with hepatitis B-positive hepatocellular carcinoma (HCC). YIV-906 is a novel, proprietary therapeutic candidate based on molecular profiling of extracts identified from use in traditional botanical medicine. YIV-906 has demonstrated that it can potentiate the anti-tumor activity of sorafenib, enhance innate and adaptive immune function in the tumor microenvironment, protect cells of the gastrointestinal tract by reducing inflammation mediated by IL-6, NF-kappaB, COX2, iNOS, and accelerate regeneration of damaged gastrointestinal tissue by promoting progenitor and stem cell growth via the Wnt signaling pathway.

“Patients and providers are eager to have evidence-based systemic treatment options for cancer, such as YIV-906,” commented Edward Chu, M.D., Chief of the Division of Hematology and Oncology, Deputy Director at the UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine and senior advisor to Yiviva. “YIV-906 applies a novel systems biology approach that has been shown in preclinical and preliminary clinical studies to enhance immune function in the tumor microenvironment and protect gastrointestinal tissue. Observations of the effects of YIV-906 in proof of concept clinical studies provide a compelling rationale for conducting this large global study in the first-line treatment setting. In addition, patients with hepatitis B-positive HCC represent a population with particularly limited treatment options where the YIV-906 approach could have a particularly significant impact on care.”

“The development of YIV-906 is a state-of-the-art approach using modern science, bioinformatics, and current GMP manufacturing to develop a precisely engineered botanical medicine,” commented Yun Yen, M.D., Ph.D., Co-Global PI Coordinator of the YIV-906 study and former President of Taipei Medical University. “The components of YIV-906 have been selected for their expected effects across multiple targets when administered as a complex mixture in combination. Given the major need for better treatments for patients with liver cancer, and the safety and efficacy profile of YIV-906 as seen to date, we look forward to the results of this global study. This could lead to new therapeutic strategies to treat cancer patients holistically.”

The randomized, placebo-controlled Phase 2b study of YIV-906 is evaluating efficacy, safety, and quality of life in patients with hepatitis B-positive HCC. The clinical study is designed to enroll approximately 125 patients at 20 sites in the U.S., mainland China, Hong Kong, and Taiwan, including Memorial Sloan Kettering Cancer Center, Taipei Medical University, Queen Mary Hospital in Hong Kong and the China National Cancer Center in Beijing. Patients will be randomized 2:1 to either the study arm (YIV-906 plus sorafenib) or control arm (placebo plus sorafenib). The primary endpoint of the study is an evaluation of progression free survival. Secondary endpoints include safety and quality of life assessments and additional measures of clinical efficacy, including time to progression, overall survival, objective response rate and disease control rate. Change of quality of life will be assessed according to HCC18 and EORTC QLQ-C30 assessments. Additional information is available at https://clinicaltrials.gov/ct2/show/NCT04000737.  

About YIV-906

YIV-906 (also PHY906 or KD018) is a therapeutic candidate comprised of a proprietary cGMP botanical extract of four herbs inspired by a traditional Chinese medicine formulation used for over a millennium. YIV-906 has the potential to be developed as a platform oncology therapeutic when administered in combination with chemotherapy, immunotherapy and radiation therapies, in multiple cancer indications. YIV-906 has been shown to enhance immune function in the tumor microenvironment (by polarizing M1 macrophages and activating T cells), protect the gastrointestinal tract (by inhibiting inflammation via IL-6, NF-kappa-B, COX2, and iNOS pathways) and promote intestinal tissue repair (by increasing activity and expression of components of the Wnt signaling pathway). YIV-906 has been observed to enhance the anti-tumor activity of sorafenib in preclinical models of hepatocellular carcinoma and has shown promise in preliminary clinical studies in liver, pancreatic, colorectal and rectal cancers. YIV-906 has been granted Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for development of YIV-906 in the treatment of hepatocellular carcinoma and pancreatic cancer. Yiviva holds worldwide intellectual property for YIV-906 including 32 patents related to methods of use, manufacturing and quality control. YIV-906 is being developed for approval under the U.S. FDA Botanical Drug regulatory pathway.

About Yiviva

Yiviva is a clinical stage biotechnology company developing multi-target botanical therapeutics using a systems biology approach, focused on cancer, inflammatory and chronic diseases. The Yiviva STAR (signal transduction, activity and response) discovery platform accelerates the identification of botanical therapeutics that influence immune function, inflammatory responses, cell growth and metabolic functions and hormone activity. Yiviva applies patented, mechanism-based quality control linked to biological activity to satisfy established regulatory requirements for complex products. The company was launched with Yale University as a co-founder and co-founders include Yung-Chi Cheng, Ph.D., with teams in New York, New Haven, Connecticut and Shanghai. For further information, please visit https://yiviva.com.

Contact:
Tel: +1 646-883-3906
Email: [email protected]

StephenW

Yiviva宣布在第一线YIV-906联合索拉非尼联合疗法治疗肝细胞癌的2b期研究中向第一位患者给药
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2020年4月6日，美国东部时间|资料来源：Yiviva
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-一流的肿瘤治疗候选者YIV-906采用了综合系统生物学方法-
-评估乙型肝炎阳性肝细胞癌患者疗效，安全性和生活质量的全球研究-

2020年4月6日，纽约和中国上海-Yiviva今天宣布，在YIV-906联合索拉非尼的2b期2b期研究中，首位患者已接受剂量治疗，以治疗B型肝炎阳性患者肝细胞癌（HCC）。 YIV-906是一种新颖的，专有的治疗性候选物，它基于从传统植物药中鉴定出的提取物的分子谱。 YIV-906已证明其可以增强索拉非尼的抗肿瘤活性，增强肿瘤微环境中的先天性和适应性免疫功能，通过减少由IL-6，NF-κB，COX2，iNOS介导的炎症来保护胃肠道细胞，并通过Wnt信号通路促进祖细胞和干细胞的生长，从而加速受损胃肠道组织的再生。

“患者和医疗服务提供者急切希望有基于证据的癌症全身治疗选择，例如YIV-906，”美国爱普生大学UPMC Hillman癌症中心副主任，血液学和肿瘤学系主任Edward Chu医师评论道。匹兹堡医学院和Yiviva高级顾问。 “ YIV-906应用了一种新颖的系统生物学方法，已在临床前和初步临床研究中证明了该方法可增强肿瘤微环境中的免疫功能并保护胃肠道组织。在概念验证临床研究中对YIV-906效果的观察为在第一线治疗环境中进行这项大型全球研究提供了令人信服的理由。此外，乙型肝炎阳性肝癌患者代表的治疗选择特别有限，YIV-906方法可能会对护理产生特别重要的影响。”

“ YIV-906的开发是一种利用现代科学，生物信息学和当前的GMP制造技术来开发精确设计的植物药的最先进方法，”联合全球医学博士Yun Yen评论说YIV-906研究的PI协调员，台北医科大学前校长。 “ YIV-906的成分已被选择，因为它们作为复杂混合物组合使用时，可以跨多个目标发挥预期效果。鉴于主要需要为肝癌患者提供更好的治疗方法，以及迄今为止看到的YIV-906的安全性和有效性，我们期待这项全球性研究的结果。这可能会导致新的治疗策略来整体治疗癌症患者。”

YIV-906的随机，安慰剂对照2b期研究正在评估乙型肝炎阳性HCC患者的疗效，安全性和生活质量。该临床研究旨在在美国，中国大陆，香港和台湾的20个地点招募约125位患者，包括斯隆·凯特琳纪念癌症中心，台北医科大学，香港皇后医院和中国国家癌症中心。北京。患者将按2：1的比例随机分配至研究组（YIV-906加索拉非尼）或对照组（安慰剂加索拉非尼）。该研究的主要终点是评估无进展生存期。次要终点包括安全性和生活质量评估以及临床疗效的其他衡量标准，包括进展时间，总体生存率，客观缓解率和疾病控制率。生活质量的变化将根据HCC18和EORTC QLQ-C30评估进行评估。有关其他信息，请访问https://clinicaltrials.gov/ct2/show/NCT04000737。
关于YIV-906

YIV-906（也称为PHY906或KD018）是一种治疗候选药物，由四种草药的专有cGMP植物提取物组成，这些提取物的灵感来自使用了千年的传统中药配方。当与多种癌症适应症的化学疗法，免疫疗法和放射疗法结合使用时，YIV-906有可能被开发为平台肿瘤治疗剂。 YIV-906已显示出增强肿瘤微环境中的免疫功能的能力（通过极化M1巨噬细胞和激活T细胞），保护胃肠道（通过通过IL-6，NF-κB，COX2和iNOS途径抑制炎症）并促进肠道组织修复（通过增加Wnt信号传导途径的活性和表达）。在肝细胞癌的临床前模型中已观察到YIV-906可增强索拉非尼的抗肿瘤活性，并已在肝癌，胰腺癌，结直肠癌和直肠癌的初步临床研究中显示出希望。 YIV-906已获美国食品药品监督管理局（FDA）授予“孤儿药”称号，以开发用于治疗肝细胞癌和胰腺癌的YIV-906。 Yiviva拥有YIV-906的全球知识产权，包括32种与使用，制造和质量控制方法有关的专利。正在根据美国FDA植物药监管途径开发YIV-906，以供批准。

关于伊维瓦

Yiviva是一家临床阶段生物技术公司，使用系统生物学方法开发多目标植物疗法，重点是癌症，炎症和慢性疾病。 Yiviva STAR（信号转导，活性和反应）发现平台可加快对影响免疫功能，炎症反应，细胞生长，代谢功能和激素活性的植物疗法的鉴定。 Yiviva采用与生物活性相关的基于机制的专利质量控制，以满足复杂产品的既定法规要求。该公司是由耶鲁大学作为联合创始人成立的，其联合创始人包括郑永智博士，并在纽约，纽黑文，康涅狄格州和上海设有团队。有关更多信息，请访问https://yiviva.com。

联系：
电话：+1 646-883-3906
电子邮件：[email protected]