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BGB-A445,a novel non-ligand-blocking agonistic anti-OX40 antibody,exhibits superior immune activation and antitumor effects in preclinical models

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Frontiers of Medicine 2023年第6期17卷 1170-1185页

作者： Beibei Jiang Tong Zhang Minjuan Deng Wei Jin Yuan Hong Xiaotong Chen Xin Chen Jing Wang Hongjia Hou Yajuan Gao Wenfeng Gong Xing Wang Haiying Li Xiaosui Zhou Yingcai Feng Bo Zhang Bin Jiang Xueping Lu Lijie Zhang Yang Li Weiwei Song Hanzi Sun Zuobai Wang Xiaomin Song Zhirong Shen Xuesong Liu Kang Li Lai Wang Ye Liu Department of Biology BeiGene(Beijing)Co.Ltd.Beijing 102206China Department of Discovery Biomarkers BeiGene(Beijing)Co.Ltd.Beijing 102206China Department of Clinic Development BeiGene(Beijing)Co.Ltd.Beijing 102206China Department of Biologics BeiGene(Beijing)Co.Ltd.Beijing 102206China

t OX40 is a costimulatory receptor that is expressed primarily on activated CD4+,CD8+,and regulatory T *** ligation of OX40 to its sole ligand OX40L potentiates T cell expansion,differentiation,and activation and also promotes dendritic cells to mature to enhance their cytokine ***,the use of agonistic anti-Ox40 antibodies for cancer immunotherapy has gained great ***,most of the agonistic anti-OX40 antibodies in the clinic are OX40L-competitive and show limited ***,we discovered that BGB-A445,a non-ligand-competitive agonistic anti-OX40 antibody currently under clinical investigation,induced optimal T cell activation without impairing dendritic cell *** addition,BGB-A445 dose-dependently and significantly depleted regulatory T cells in vitro and in vivo via antibody-dependent cellular *** the MC38 syngeneic model established in humanized OX40 knock-in mice,BGB-A445 demonstrated robust and dose-dependent antitumor efficacy,whereas the ligand-competitive anti-Ox40 antibody showed antitumor efficacy characterized by a hook ***,BGB-A445 demonstrated a strong combination antitumor effect with an anti-PD-1 *** together,our findings show that BGB-A445,which does not block OX40-OX40L interaction in contrast to clinical-stage anti-OX40 antibodies,shows superior immune-stimulating effects and antitumor efficacy and thus warrants further clinical investigation.

关键词： BGB-A445 OX40 agonistic antibody OX40L noncompetitive

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A proposal:a comprehensive platform to characterize tumors in Chinese and improve success in cancer drug discovery and development

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Chinese Journal of Cancer 2011年第6期30卷 363-367页

作者： Pearl S. Huang Peter T. Ho Kang Zhang beigene ltd. Beijing 102206 P. R. China Molecular Medicine Center West China Hospital Sichuan University Chengdu SJchuan 610041 P. R. China Institute for Genomic Medicine and Shiley Eye Center University of California at San Diego La Jolla CA 92093 USA.

Cancer is a collection of complex diseases in which cell proliferation and apoptosis are dysregulated due to the acquisition of genetic changes in cancer *** genetic changes,combined with the interrelated physiologic adaptations of neo-angiogenesis,recruitment of stromal support tissues,and suppression of immune recognition,are measurable characteristics in tumor gene expression profiles and biochemical *** measures can lead to identification of disease drivers and,ultimately,can be used to assign *** advances in RNA sequencing technologies,the ability to simultaneously measure all genetic and gene expression changes with a single technology is now *** ability to create a comprehensive catalog of genotypic and phenotypic changes in a collection of histologically similar but otherwise distinct tumors should allow for a more precise positioning of existing targeted therapies and identification of new targets for intervention.

关键词：药物发现肿瘤基因表达谱开发抗癌中国平台基因变化

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A Brief Review of the Clinical Pharmacology Expansion Cohorts in FIH Oncology Trials

A Brief Review of the Clinical Pharmacology Expansion Cohort...

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2018年中国药理学会定量药理学专业委员会学术年会

作者： Qiuyang Zhang Tingting Yao Yan Ren Department of Clinical Pharmacology BeiGene (Shanghai) Co.Ltd

Background The use of expansion cohorts in first-in-human(FIH) trials has become a seamless strategy for improving the efficiency of novel drug development especially in oncology therapeutic *** purpose of conducting these expansion cohorts can be assessing anti-tumor activity in a diseaseand/or population-specific setting,evaluating alternative doses or schedules,exploring potential biomarker and collecting clinical pharmacology information to optimize later phase dosing *** a new FDA draft guidance was published to emphasize the advantage of conducting multiple expansion cohorts in FIH trials drug development,with the goal of making highly effective drugs widely available to the public as quickly as possible

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Effects of pulsation ratio on center temperature and drying characteristics of pineapple slices with pulsed vacuum drying

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International Journal of Agricultural and Biological Engineering 2022年第6期15卷 242-253页

作者： Dalong Jiang Congcong Li Zifan Lin Yuntian Wu Hongjuan Pei School of Computer and Control Engineering Yantai UniversityYantai 264005ShandongChina Hebei Agricultural University Baoding 071001HebeiChina Hebei Key Laboratory of Agricultural Big Data Baoding 071001HebeiChina Department of Electrical and Electronic Engineering University of Western AustraliaPerth 6000Australia beigene Guangzhou Biologics Manufacturing Co. LtdGuangzhou 510555China Neuroscience and Intelligent Media Institute Communication University of ChinaBeijing 100024China

This research explored the application of pulsed vacuum technology on the drying(PVD)of pineapple *** of drying temperature and pulsed vacuum ratio(PVR)on drying characteristics and pineapple quality(color,rehydration characteristics,microstructure,and texture)were *** expected,increasing the drying temperature resulted in a higher drying rate and effective moisture *** optimal PVR of 5:5 was beneficial in accelerating the drying rate of pineapple slices and the corresponding effective moisture diffusion coefficient(8.9601×10^(-10))was higher than other PVR conditions based on material center *** material temperature increased during the normal pressure period and decreased rapidly when the pressure dropped to the vacuum condition,which indirectly reflected the moisture transfer that occurred during the vacuum holding period,while moisture diffusion happened during the atmospheric pressure holding *** optimal pulsed vacuum drying process(PVR of 5:5)could expand air and water vapor and create a looser structure so as to obtain better rehydration performance(rehydration ratio(RR)was 5.43).High drying temperature led to the decrease of L^(*)value,the increase ofΔE value,and even the formation of surface scorch at 80℃.At the same drying temperature,the color quality depended on the drying time,and the color difference increased with the extension of the drying *** chewiness and hardness of pineapple slices dried by PVD were significantly higher than those of fresh samples,which was conducive to the chewing taste.

关键词： pulsed vacuum drying pineapple slices color rehydration ratio texture center temperature

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Experimental and numerical study on the shrinkage-deformation of carrot slices during hot air drying

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International Journal of Agricultural and Biological Engineering 2023年第1期16卷 260-272页

作者： Dalong Jiang Congcong Li Zifan Lin Yuntian Wu Hongjuan Pei Magdalena Zielinska Hongwei Xiao School of Computer and Control Engineering Yantai UniversityYantai 264005ShandongChina Hebei Agricultural University Baoding 071001HebeiChina Hebei Key Laboratory of Agricultural Big Data Baoding 071001HebeiChina Department of Electrical and Electronic Engineering University of Western AustraliaPerth 6000Australia beigene Guangzhou Biologics Manufacturing Co. LtdGuangzhou 510555China Neuroscience and Intelligent Media Institute Communication University of ChinaBeijing 100024China Department of Systems Engineering University of Warmia and MazuryOlsztyn 004889Poland College of Engineering China Agricultural UniversityBeijing 100083China

In order to further understand the mechanism of material volume change in the drying process,numerical simulations(considering or neglecting shrinkage)of heat and mass transfer during convective drying of carrot slices under constant and controlled temperature and relative humidity were carried *** results were validated with experimental *** results of the simulation show that the Quadratic model fitted well to the moisture ratio and the material temperature data trend with average relative errors of 5.9%and 8.1%,***,the results of the simulation considering shrinkage show that the moisture and temperature distributions during drying are closer to the experimental data than the results of the simulation disregarding *** material moisture content was significantly related to the shrinkage of dried *** and relative humidity significantly affected the volume shrinkage of carrot *** volume shrinkage increased with the rising of the constant temperature and the decline of relative *** model can be used to provide more information on the dynamics of heat and mass transfer during drying and can also be adapted to other products and dryers devices.

关键词： carrot drying numerical simulation heat and mass transfer shrinkage

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Tislelizumab in previously treated,locally advanced unresectable/metastatic microsatellite instability-high/mismatch repair-deficient solid tumors

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Chinese Journal of Cancer Research 2024年第3期36卷 257-269页

作者： Jian Li Ye Xu Aimin Zang Yunong Gao Quanli Gao Yanqiao Zhang Dong Wang Jianming Xu Ying Yuan Haiping Jiang Jieer Ying Chunmei Shi Yanhong Deng Jing Wang Tianshu Liu Yi Huang Xiaoping Qian Yueyin Pan Ying Cheng Sheng Hu Jin Wang Mengyue Shi Ke Wang Han Hu Lin Shen State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers Beijing Key Laboratory of Carcinogenesis and Translational ResearchDepartment of Gastrointestinal OncologyPeking University Cancer Hospital&InstituteBeijing 100142China Department of Oncology Fudan University Shanghai Cancer CenterShanghai 200032China Department of Medical Oncology Affiliated Hospital of Hebei UniversityBaoding 071000China Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing) Department of GynecologyPeking University Cancer Hospital&InstituteBeijing 100142China Department of Immunotherapy Henan Cancer HospitalZhengzhou 450001China Department of Gastrointestinal Oncology Affiliated Cancer Hospital of Harbin Medical UniversityHarbin 150086China Department of Gastrointestinal Oncology Chongqing University Cancer HospitalChongqing 400030China Department of Gastrointestinal Oncology the Fifth Medical CenterChinese PLA General HospitalBeijing 100048China Department of Medical Oncology the Second Affiliated HospitalZhejiang University School of MedicineHangzhou 310009China Department of Medical Oncology the First Affiliated HospitalZhejiang University School of MedicineHangzhou 310003China Department of Medical Oncology Cancer Hospital of the University of Chinese Academy of SciencesHangzhou 310022China Department of Medical Oncology Fujian Medical University Union HospitalFuzhou 350001China Department of Oncology the Sixth Affiliated HospitalSun Yat-sen UniversityGuangzhou 510655China Department of Medical Oncology Hunan Cancer HospitalChangsha 410013China Department of Medical Oncology Zhongshan HospitalFudan UniversityShanghai 200032China Department of Immunotherapy Hubei Cancer HospitalWuhan 430079China Department of Medical Oncology the Affiliated Hospital of Nanjing University Medical SchoolNanjing 210008China Department of Medical Oncology Anhui Provincial HospitalHefei 230001China Department of Medical Oncology Jilin Cancer Hospital

Objective:The open-label,phase II RATIONALE-209 study evaluated tislelizumab(anti-programmed cell death protein 1 antibody)as a tissue-agnostic monotherapy for microsatellite instability-high(MSI-H)/mismatch repair-deficient(dMMR)***:Adults with previously treated,locally advanced unresectable or metastatic MSI-H/dMMR solid tumors were *** received tislelizumab 200 mg intravenously every 3 *** response rate(ORR;primary endpoint),duration of response(DoR),and progression-free survival(PFS)were assessed by independent review committee(Response Evaluation Criteria in Solid Tumors v1.1).Results:Eighty patients were enrolled and treated;75(93.8%)patients had measurable disease at *** had metastatic disease and received at least one prior therapy for advanced/metastatic disease(n=79;98.8%).At primary analysis(data cutoff July 8,2021;median follow-up 15.2 months),overall ORR[46.7%;95%confidence interval(95%CI),35.1−58.6;one-sided P<0.0001]and ORR across tumor-specific subgroups[colorectal(n=46):39.1%(95%CI,25.1–54.6);gastric/gastroesophageal junction(n=9):55.6%(95%CI,21.2−86.3);others(n=20):60.0%(95%CI,36.1−80.9)]were significantly greater with tislelizumab vs.a prespecified historical control ORR of 10%;five(6.7%)patients had complete *** DoR,PFS,and overall survival were not reached with long-term follow-up(data cutoff December 5,2022;median follow-up 28.9 months).Tislelizumab was well tolerated with no unexpected safety ***-related adverse events(TRAEs)of grade≥3 occurred in 53.8%of patients;7.5%of patients discontinued treatment due to ***:Tislelizumab demonstrated a significant ORR improvement in patients with previously treated,locally advanced unresectable or metastatic MSI-H/dMMR tumors and was generally well tolerated.

关键词： Biomarkers DNA mismatch repair immune checkpoint inhibitors microsatellite instability phase II clinical trials programmed cell death 1 receptor

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A New Prognostic Model Covering All Stages of Intrahepatic Cholangiocarcinoma

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Journal of Clinical and Translational Hepatology 2022年第2期10卷 254-262页

作者： Shuang-Nan Zhou Shan-Shan Lu Da-Wei Ju Ling-Xiang Yu Xiao-Xiao Liang Xiao Xiang Suthat Liangpunsakul Lewis R.Roberts Yin-Ying Lu Ning Zhang Department of Infectious Disease the Fifth Medical Center of Chinese PLA General HospitalBeijingChina Department of Liver Disease the Fifth Medical Center of Chinese PLA General HospitalBeijingChina Beijing Advanced Innovation Center for Soft Matter Science and Engineering College of Life Science and TechnologyBeijing University of Chemical TechnologyBeijingChina Central Theater Command General Hospital of The Chinese People’s Liberation Army WuhanHubeiChina Beijing Chaoyang Integrative Medicine Emergency Medical Center BeijingChina beigene(Beijing)Co.ltd BeijingChina Division of Gastroenterology and Hepatology Department of MedicineIndiana University School of MedicineINUSA Department of Biochemistry and Molecular Biology Indiana University School of MedicineIndianapolisINUSA Division of Gastroenterology and Hepatology Mayo Clinic College of Medicine and ScienceRochesterMNUSA

Background and Aims:Intrahepatic cholangiocarcinoma(ICC)is the second most common primary hepatic malignancy that causes a poor *** aimed to identify its prognostic factors and to develop a nomogram that will predict survival of ICC patients among all ***:A total of 442 patients with pathology-proven ICC registered at the Fifth Medical Center of PLA General Hospital between July 2007 and December 2019 were *** were followed for survival status until June 30,2020.A prognostic model visualized as a nomogram was constructed in the training cohort using multivariate cox model,and was then validated in the validation ***:The median age was 55 *** a median follow-up of 50.4 months,337 patients *** median survival was 11.6 months,with 1-,3-and 5-year survival rates of 48.3%,22.7%and 16.2%,*** associated with overall survival were multiple tumors,lymph node involvement,vascular invasion,distant metastasis,decreased albumin,elevated lactate dehydrogenase(LDH),decreased iron,elevated fi-brinogen,elevated CA125 and elevated CA19-9.A nomo-gram predicting survival of ICC patients at the time of di-agnosis achieved a Harrel’s c-statistic of 0.758,significantly higher than the 0.582 of the TNM stage *** median survivals of those within the low,mid and high-risk subgroups were 35.6,12.1 and 6.2 months,***:A nomogram based on imaging data and serum biomarkers at diagnosis showed good ability to predict survival in patients with all stages of *** studies are needed to validate the prognostic capability of our new model.

关键词： Intrahepatic cholangiocarcinoma Prognostic model Nomogram Risk stratification

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