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Penpulimab,an anti-PD-1 antibody,for heavily pretreated metastatic nasopharyngeal carcinoma:a single-arm phase II study

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Signal Transduction and Targeted Therapy 2024年第7期9卷 3056-3062页

作者： Xiaozhong Chen Wei Wang Qingfeng Zou Xiaodong Zhu Qin Lin Yi Jiang Yan Sun Liangfang Shen Lin Wang Guorong Zou Xiaoyan Lin Shaojun Lin Minying Li Ying Wang Ruilian Xu Rui Ao Rensheng Wang Haifeng Lin Shuang Huang Tingting Xu Wenting Li Mengying Xia Yu Xia Zhongmin Wang Baiyong Li Jingao Li Chaosu Hu department of Radiation Oncology Cancer Hospital of the University of ChineseAcademy of Sciences(Zhejiang Cancer Hospital)HangzhouChina Gastroenterology and Urology department II Hunan Cancer Hospital/the Affiliated Cancer Hospital of Xiangya School of MedicineCentral South UniversityChangshaChina Clinical Research Center for Gastrointestinal Cancer in Hunan Province ChangshaChina department of Medical Oncology Affiliated Cancer Hospital&Institute of Guangzhou Medical UniversityGuangzhouChina department of Radiation Oncology Guangxi Medical University Affiliated Tumor Hospital&Key Laboratory of Early Prevention and Treatment for Regional High Frequency Tumor(Guangxi Medical University)Ministry of Education&Guangxi Key Laboratory of Early Prevention and Treatment for Regional High Frequency TumorGuangxi Medical UniversityNanningChina department of Radiation Oncology Cancer CenterThe First Affiliated Hospital of Xiamen UniversityXiamenChina department of Medical Oncology Cancer Hospital of Shantou University Medical CollegeShantouChina department of Radiation Oncology Peking University Cancer Hospital&InstituteBeijingChina department of Oncology Xiangya Hospital Central South UniversityChangshaChina department of Medical Oncology Hainan General HospitalHainan Affiliated Hospital of Hainan Medical UniversityHaikouChina department of Oncology The Affiliated Panyu Central Hospital of Guangzhou Medical UniversityGuangzhouChina department of Medical Oncology Fujian Medical University Union HospitalFuzhouChina department of Radiation Oncology Clinical Oncology School of Fujian Medical UniversityFujian Cancer HospitalFuzhouChina department of Radiation Therapy for Thoracic Tumors Zhongshan City People’s HospitalZhongshanChina Tumor Radiotherapy Center Chongqing University Cancer HospitalChongqing Cancer HospitalChongqing Cancer InstituteChongqingChina department of Oncology Shenzhen People’s Hospital(The Second Clinical Medical CollegeJinan UniversityThe First Affiliated HospitalSo

Penpulimab is an anti-programmed cell death-1(PD-1)IgG1 antibody with no Fc gamma receptor(FcγR)binding activity,and thus theoretically reduced immune-related adverse events(irAEs)while maintaining *** single-arm,phase II trial conducted across 20 tertiary care centers in China enrolled adult patients with metastatic nasopharyngeal carcinoma(NPC)who had failed two or more lines of previous systemic *** received 200-mg penpulimab intravenously every 2 weeks(4 weeks per cycle)until disease progression or intolerable *** primary endpoint was objective response rate(ORR)per RECIST(version 1.1),as assessed by an independent radiological review *** secondary endpoints included progression-free survival(PFS)and overall survival(OS).One hundred thirty patients were enrolled and 125 were efficacy *** the data cutoff date(September 28,2022),1 patient achieved complete response and 34 patients attained partial *** ORR was 28.0%(95%CI 20.3–36.7%).The response was durable,with 66.8%still in response at 9 ***-three patients(26.4%)were still on *** median PFS and OS were 3.6 months(95%CI=1.9–7.3 months)and 22.8 months(95%CI=17.1 months to not reached),***(7.6%)patients experienced grade 3 or higher *** has promising anti-tumor activities and acceptable toxicities in heavily pretreated metastatic NPC patients,supporting further clinical development as third-line treatment of metastatic NPC.

关键词： metastatic nasopharyngeal supporting

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Unconjugated bilirubin alleviates experimental ulcerative colitis by regulating intestinal barrier function and immune inflammation

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World Journal of Gastroenterology 2019年第15期25卷 1865-1877页

作者： Jia-Dong Zheng Yan He Heng-Yuan Yu Yuan-Li Liu Yi-Xuan Ge Xue-Ting Li Xue Li Yan Wang Meng-Ru Guo Yi-Lin Qu Xiao-Fa Qin Ming-Shan Jiang Xiu-Hong Wang department of Biochemistry and Molecular Biology Heilongjiang Provincial Science and Technology Innovation Team in Higher EducationInstitutes for Infection and Immunity Harbin Medical University GI biopharma Inc. department of General Surgery the Second Affiliated Hospital of Harbin Medical University

BACKGROUND Unconjugated bilirubin(UCB) is generally considered toxic but has gained recent prominence for its anti-inflammatory properties. However, the effects of it on the interaction between intestinal flora and organisms and how it influences immune responses remain *** To investigate the role of UCB in intestinal barrier function and immune inflammation in mice with dextran-sulfate-sodium-induced *** Acute colitis was induced by 3%(w/v) dextran sulfate sodium salt in drinking water for 6 d followed by untreated water for 2 d. Concurrently, mice with colitis were administered 0.2 mL UCB(400 μmol/L) by intra-gastric gavage for 7 *** activity index(DAI) was monitored daily. Mice were sacrificed at the end of the experiment. The length of the colon and weight of the spleen were recorded. Serum level of D-lactate, intestinal digestive proteases activity, and changes to the gut flora were analyzed. In addition, colonic specimens were analyzed by histology and for expression of inflammatory markers and *** Mice treated with UCB had significantly relieved severity of colitis, including lower DAI, longer colon length, and lower spleen weight(colon length: 4.92 ±0.09 cm vs 3.9 ± 0.15 cm; spleen weight: 0.33 ± 0.04 vs 0.74 ± 0.04, P < 0.001). UCB administration inactivated digestive proteases(chymotrypsin: 18.70 ± 0.69 U/g vs44.81 ± 8.60 U/g; trypsin: 1.52 ± 0.23 U/g vs 9.05 ± 1.77 U/g, P < 0.01), increased expression of tight junction(0.99 ± 0.05 vs 0.57 ± 0.03, P < 0.001), decreased serum level of D-lactate(31.76 ± 3.37 μmol/L vs 54.25 ± 1.45 μmol/L, P < 0.001), and lowered histopathological score(4 ± 0.57 vs 7 ± 0.57, P < 0.001) and activity of myeloperoxidase(46.79 ± 2.57 U/g vs 110.32 ± 19.19 U/g, P < 0.001). UCB also regulated the intestinal microbiota, inhibited expression of tumor necrosis factor(TNF) α and interleukin 1β(TNF-α: 52.61 ± 7.81 pg/mg vs 105.04 ± 11.92 pg/mg,interleukin 1β: 13.43 ± 1.68 vs 32.41 ± 4.62 pg/mg,

关键词： Ulcerative colitis Unconjugated bilirubin Intestinal barrier Intestinal homeostasis Digestive proteases Inflammation

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Effect of Excipients on Recombinant Interleukin-2 Stability in Aqueous Buffers

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American Journal of Analytical Chemistry 2021年第10期12卷 347-372页

作者： A. S. Prakasha Gowda Andrew D. Schaefer Terry K. Schuck department of Raw Materials Eurofins BioPharma Product Testing Lancaster USA

In order to retain structural and functional integrity, protein medicines are frequently stabilized with excipients in aqueous solutions. The goal of this investigation was to see how stable IL-2 is with excipients that are acceptable for cell therapy. We investigated the time-dependent stability of commercially available recombinant IL-2 in aqueous solutions (CTS, RPMI, PBS, and water) at different temperatures [2°C - 8°C, room temperature (20°C ± 2°C) and 37°C] in the presence of excipients (EDTA, methionine, histidine, and glycine) over a period of up to 30 days. To detect and quantify IL-2, reversed phase high performance liquid chromatography was employed. Electrophoresis on a sodium dodecyl sulfate polyacrylamide gel was used to assess conformational stability. We discovered that IL-2 stability was improved in aqueous solutions including excipients, and that it may have retained its biological activity and sterility in these conditions.

关键词： Interleukin-2 Excipients Stability RP-HPLC SDS-PAGE

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Safety, immunogenicity and protective effectiveness of heterologous boost with a recombinant COVID-19 vaccine (Sf9 cells) in adult recipients of inactivated vaccines

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Signal Transduction and Targeted Therapy 2024年第3期9卷 1165-1173页

作者： Wenxin Luo Jiadi Gan Zhu Luo Shuangqing Li Zhoufeng Wang Jiaxuan Wu Huohuo Zhang Jinghong Xian Ruixin Cheng Xiumei Tang Yi Liu Ling Yang Qianqian Mou Xue Zhang Yi Chen Weiwen Wang Yantong Wang Lin Bai Xuan Wei Rui Zhang Lan Yang Yaxin Chen Li Yang Yalun Li Dan Liu Weimin Li Lei Chen department of Pulmonary and Critical Care Medicine West China HospitalSichuan UniversityChengduChina Institute of Respiratory Health Frontiers Science Center for Disease-related Molecular NetworkWest China HospitalSichuan UniversityChengduChina Precision Medicine Center Precision Medicine Key Laboratory of Sichuan ProvinceWest China HospitalSichuan UniversityChengduChina State Key Laboratory of Respiratory Health and Multimorbidity West China HospitalChengduChina Institute of Respiratory Health and Multimorbidity West China HospitalSichuan UniversityChengduChina Clinical Trial Center West China HospitalSichuan UniversityChengduChina General Practice Medical Center West China HospitalSichuan UniversityChengduChina Fangcao Community Health Service Center of Chengdu High-tech Zone ChengduChina The Research Units of West China Chinese Academy of Medical SciencesWest China HospitalChengduChina West China School of Nursing Sichuan UniversityChengduChina department of Infection Control West China HospitalSichuan UniversityChengduChina department of Pathology West China HospitalSichuan UniversityChengduChina department of Respiratory and Critical Care Medicine the First Affiliated Hospital of Chongqing Medical UniversityChongqingChina department of Neurology West China HospitalSichuan UniversityChengduChina

Vaccines have proven effective in protecting populations against COVID-19,including the recombinant COVID-19 vaccine(Sf9 cells),the first approved recombinant protein vaccine in *** this positive-controlled trial with 85 adult participants(Sf9 cells group:n=44;CoronaVac group:n=41),we evaluated the safety,immunogenicity,and protective effectiveness of a heterologous boost with the Sf9 cells vaccine in adults who had been vaccinated with the inactivated vaccine,and found a post-booster adverse events rate of 20.45%in the Sf9 cells group and 31.71%in the CoronaVac group(p=0.279),within 28 days after booster *** group reported any severe adverse *** the Sf9 cells vaccine booster,the geometric mean titer(GMT)of binding antibodies to the receptor-binding domain of prototype SARS-CoV-2 on day 28 post-booster was significantly higher than that induced by the CoronaVac vaccine booster(100,683.37 vs.9,451.69,p<0.001).In the Sf9 cells group,GMTs of neutralizing antibodies against pseudo SARS-CoV-2 viruses(prototype and diverse variants of concern[VOCs])increased by 22.23–75.93 folds from baseline to day 28 post-booster,while the CoronaVac group showed increases of only 3.29–10.70 ***,neutralizing antibodies against live SARS-CoV-2 viruses(prototype and diverse VOCs)increased by 68.18–192.67 folds on day 14 post-booster compared with the baseline level,significantly greater than the CoronaVac group(19.67–37.67 folds).A more robust Th1 cellular response was observed with the Sf9 cells booster on day 14 post-booster(mean IFN-γ+spot-forming cells per 2×105 peripheral blood mononuclear cells:26.66 vs.13.59).Protective effectiveness against symptomatic COVID-19 was approximately twice as high in the Sf9 cells group compared to the CoronaVac group(68.18%vs.36.59%,p=0.004).Our study findings support the high protective effectiveness of heterologous boosting with the recombinant COVID-19 vaccine(Sf9 cells)against symptomatic COVID-19 of dive

关键词： protective vaccine boost

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Culturing adequate CAR-T cells from less peripheral blood to treat B-cell malignancies

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Cancer Biology & Medicine 2021年第4期18卷 1066-1079页

作者： Lu Han Jian Zhou Linlin Li Keshu Zhou Lingdi Zhao Xinghu Zhu Qingsong Yin Yufu Li Hongqin You Jishuai Zhang Yongping Song Quanli Gao department of Immunology Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer HospitalZhengzhou 450008China department of Hematology Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer HospitalZhengzhou 450008China department of Medical Microbiology School of Basic Medical SciencesXinxiang Medical UniversityXinxiang 453003China The Shenzhen Pregene biopharma Company Ltd.Shenzhen 518118China

Objective:Chimeric antigen receptor-modified T(CAR-T)cells have shown impressive results against relapsed/refractory B cell ***,the traditional manufacture of CAR-T cells requires leukapheresis to isolate large amounts of peripheral blood T cells,thus making some patients ineligible for the ***:We developed a simple method for CAR-T cell preparation requiring small volumes of peripheral ***,CD3+T cells isolated from 50 mL peripheral blood from patients(B-cell malignancies)were stimulated with immobilized anti-CD3/RetroNectin in 6-well plates and then transduced with CAR-expressing lentiviral *** 4 d,the T cells were transferred to culture bags for large-scale CAR-T cell *** vitro and animal experiments were performed to evaluate the activity of the manufactured CAR-T ***,29 patients with B-cell acute lymphoblastic leukemia(B-ALL)and 9 patients with B-cell lymphoma were treated with the CAR-T ***:The CAR-T cells were expanded to 1–3×10^(8) cells in 8–10 d and successfully killed B cell-derived malignant tumor cells in vitro and in *** patients with B-ALL,the complete remission rate was 93%1 month after CAR-T cell infusion;after 12 months,the overall survival(OS)and leukemia-free survival rates were 69%and 31%,*** patients with lymphoma,the objective response rate(including complete and partial remission)was 78%2 months after CAR-T cell infusion,and after 12 months,the OS and progression-free survival rates were 71%and 43%,***-release syndrome(CRS)occurred in 65.51%and 55.56%of patients with B-ALL and B-cell lymphoma,respectively;severe CRS developed in 20.69%of patients with B-ALL and in no patients with ***:Our novel method can generate sufficient numbers of CAR-T cells for clinical use from 50–100 mL peripheral blood,thus providing an alternative means of CAR-T cell generation for patients ineligible for leukapheresis.

关键词： Fewer initial lymphocytes peripheral blood CAR-T cells B-cell malignancy acute lymphoblastic leukemia

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Assays for RNA synthesis and replication by the hepatitis C virus

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Frontiers in Biology 2012年第3期7卷 233-245页

作者： C. Cheng KAO Baochang FAN Sreedhar CHINNASWAMY Hui CAI C.T. RANJITH-KUMAR Jerome DEVAL department of Molecular & Cellular Biochemistry Indiana University Bloomington IN 47405 USA National Institute of Biomedical Genomics (NIBMG) NSS Kalyani WB-74125L India Alios biopharma lnc. South San Francisco CA 94080 USA

At least six major genotypes of Hepatitis C virus （HCV） cause liver diseases worldwide. The efficacy rates with current standard of care are about 50% against genotype 1, the most prevalent strain in the United States, Europe and Japan. Therefore more effective pan-genotypic therapies are needed. HCV RNA replication provides a number of validated targets for virus-specific and potentially pan-genotypic inhibitors. In vitro assays capturing the different steps of RNA synthesis are needed not only to identify new inhibitors, but also to examine their mechanisms of action. This review attempts to provide a comprehensive summary of the biochemical, cell-based and animal model systems to assess HCV polymerase activity and HCV RNA replication that should be useful for both basic research and applied studies.

关键词： assay RNA synthesis and replication hepatitis C virus

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Development of a radiolabeled site-specific single-domain antibody positron emission tomography probe for monitoring PD-L1 expression in cancer

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Journal of Pharmaceutical Analysis 2022年第6期12卷 869-878页

作者： Yinfei Chen Shiyu Zhu Jiayu Fu Jianguo Lin Yan Sun Gaochao Lv Minhao Xie Tao Xu Ling Qiu NHC Key Laboratory of Nuclear Medicine Jiangsu Key Laboratory of Molecular Nuclear MedicineJiangsu Institute of Nuclear MedicineWuxiJiangsu214063China department of Radiopharmaceuticals School of PharmacyNanjing Medical UniversityNanjing211166China Smart Nuclide biopharma Co. Ltd.SuzhouJiangsu215123China

Despite advances in immunotherapy for the treatment of cancers,not all patients can benefit from programmed cell death ligand 1(PD-L1)immune checkpoint blockade ***-PD-L1 therapeutic effects reportedly correlate with the PD-L1 expression level;hence,accurate detection of PD-L1 expression can guide immunotherapy to achieve better therapeutic ***,based on the high affinity antibody Nb109,a new site-specifically radiolabeled tracer,^(68)Ga-NODA-cysteine,aspartic acid,and valine(CDV)-Nb109,was designed and synthesized to accurately monitor PD-L1 *** tracer ^(68)Ga-NODA-CDV-Nb109 was obtained using a site-specific conjugation strategy with a radiochemical yield of about 95%and radiochemical purity of 97%.It showed high affinity for PD-L1 with a dissociation constant of 12.34±1.65 *** the cell uptake assay and positron emission tomography(PET)imaging revealed higher tracer uptake in PD-L1-positive A375-hPD-L1 and U87 tumor cells than in PD-L1-negative A375 tumor ***,dynamic PET imaging of a NCI-H1299 xenograft indicated that doxorubicin could upregulate PD-L1 expression,allowing timely interventional *** conclusion,this tracer could sensitively and dynamically monitor changes in PD-L1 expression levels in different cancers and help screen patients who can benefit from anti-PD-L1 immunotherapy.

关键词： Single-domain antibody Site-specific labeling Immuno-PET imaging PD-L1

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Targeted drug approvals in 2023:breakthroughs by the FDA and NMPA

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Signal Transduction and Targeted Therapy 2024年第3期9卷 813-821页

作者： Lang Zheng Wenjing Wang Qiu Sun department of Biotherapy Cancer Center and State Key Laboratory of BiotherapyWest China HospitalSichuan UniversityChengdu 610041China West China Medical Publishers West China HospitalSichuan UniversityChengdu 610041China

According to the official website of China’s National Medicines and Pharmaceutical Administration(NMPA),a total of 87 novel drugs were approved in China in 2023,with targeted drugs accounting for 67.8%of the total,amounting to 59 drugs(Fig.1a;Table 1)[https://***/yaopin/ypjgdt/***].Notably,domestic innovation is flourishing,with five first-in-class drugs,including Glumetinib,a c-Met inhibitor from Haihe biopharma;Leritrelvir,a 3CL protease inhibitor from Raynovent;Anaprazole,a proton pump inhibitor from Xuanzhu Biopharm;Pegol-Sihematide,an EPO drug from Hansoh Pharma;and Zuberitamab from BioRay biopharmaceutical Co.,***,the world’s first allosteric inhibitor targeting TYK2,Sotyktu(deucravacitinib),has been approved for the treatment of psoriasis and Selumetinib,a MEK inhibitor co-developed by AstraZeneca and Merck Sharp&Dohme(MSD),became the first approved drug in China for the treatment of neurofibromatosis type I(NF1).Beyond these drugs,the approval of novel drug types such as CAR-T cell products,siRNA,monoclonal antibodies,dual antibodies,and ADCs in China is a significant development in the country’s pharmaceutical industry(Fig.1a).

关键词： drugs Merck approval

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Characterization of a Liquid Crystal Stabilized Pharmaceutical Oil-in-Water Emulsion Optimized for Skin Delivery

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Journal of Cosmetics, Dermatological Sciences and Applications 2018年第4期8卷 207-217页

作者： Melinda J. Sutton David W. Osborne Kevin Dahl Victoria Bax G. Alan Schick department of Chemistry Missouri State University Springfield MO USA Dow Development Institute Petaluma CA USA KBI biopharma Boulder CO USA

A moisturizing cream containing 25 wt% of an organic solvent, diethylene glycol monoethyl ether (DEGEE), is observed to be stabilized by an emulsifying wax blend of cetearyl alcohol, dicetyl phosphate, and ceteth-10 phosphate (tradename Crodafos CES). Polarized light microscopy indicates that the Crodafos CES helps to produce a liquid-crystal stabilized oil-in-water emulsion, which is physically stable for months under accelerated aging conditions and chemically stable over the full topical pH range of 3.5 to 9. Emulsion globule size in the cream is observed to be dependent on the degree of emulsifying wax neutralization, with the globule size decreasing with increasing cream pH. The superior solubilizing properties of DEGEE combined with the full pH range and liquid-crystal stabilizing properties of the Crodafos CES give this formulation the potential for a wide range of applications in the topical delivery of active pharmaceutical ingredients.

关键词： Pharmaceutical Emulsion Skin Delivery Liquid Crystal Stabilized Emulsion Polarized Light Microscopy Topical Formulation

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How to Write a Medical Research Paper for an International Journal

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中国真菌学杂志 2010年第6期5卷 370-375页

作者： Glenn S.Bulmer Robert A.Fromtling department of Dermatology/Research Center of Medical Mycology Peking University First Hospital department of biopharma University of Medicine and Dentistry of New JerseyNewarkNJUSA and MerckSharp & DohmeRahway

Western-raised scientists are taught with the traditional concepts of:purpose,method,observation and *** is not true for Chinese educated *** all international journals publish papers following these,or similar parameters,the Chinese scientist who wishes to publish in such a journal,must adjust his thinking to fit within this *** this presentation we wish to assist our Chinese colleagues on how this thought process can be followed.

关键词：医学教育书写格式期刊出版工作中国

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