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Construction of paclitaxel-based antibody–drug conjugates with a PEGylated linker to achieve superior therapeutic index

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Signal Transduction and Targeted Therapy 2020年第1期5卷 1258-1260页

作者： Ting Shao Tianzhi Chen Yuning Chen Xiaoyue Liu Yi-Li Chen Qi Wang Tong Zhu Maojun Guo Hui Li Dianwen Ju Chunhe Wang Biotherapeutics Discovery Research Center Shanghai Institute of Materia MedicaChinese Academy of SciencesShanghai 200126China dartsbio pharmaceuticals 528400 ZhongshanGuangdongChina Levena Biopharma B8-301218 Xinghu StreetSIPSuzhouJiangsu 215123China Department of Biological Medicines&Shanghai Engineering Research Center of Immunotherapeutics Fudan University School of Pharmacy201203 ShanghaiChina

Dear Editor,The selection of linkers and payloads plays a crucial role in determining the therapeutic indices of antibody–drug conjugates(ADCs).1 Valine–citrulline(Val–Cit)coupled with a self-immolativeρ-aminobenzyl(PAB)spacer as a cleavable dipeptide linker,designated as“VC linker”in this letter,has been popularly used in ADC conjugation.1 However,VC linker is highly hydrophobic2 and,together with hydrophobic payloads at high DARs(drug-toantibody ratios),may turn ADC molecules that have hydrophilic parts in their antibody portions,into aggregation-prone“surfactant-like”structures.

关键词： hydrophobic letter surfactant

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Enzyme-linked immunosorbent assays for quantification of MMAE-conjugated ADCs and total antibodies in cynomolgus monkey sera

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Journal of Pharmaceutical Analysis 2022年第4期12卷 645-652页

作者： Min Pei Tingting Liu Lu Ouyang Jianhua Sun Xiaojie Deng Xiaomin Sun Wei Wu Peng Huang Yi-Li Chen Xiaorong Tan Xiaoyue Liu Peng Zhu Yongzhen Liu Deheng Wang Junliang Wu Qi Wang Guifeng Wang Likun Gong Qiuping Qin Chunhe Wang Biotherapeutics Discovery Research Center Shanghai Institute of Materia MedicaChinese Academy of SciencesShanghai201203China School of Pharmacy University of Chinese Academy of SciencesBeijing100049China Center for Drug Safety Evaluation and Research Shanghai Institute of Materia MedicaChinese Academy of SciencesShanghai201203China Research and Development Center Dartsbio Pharmaceuticals Ltd.ZhongshanGuangdong528400China Zhongshan Institute for Drug Discovery Shanghai Institute of Materia MedicaChinese Academy of SciencesZhongshanGuangdong528400China School of Pharmacy Shanghai Engineering Research Center of ImmunotherapeuticsFudan UniversityShanghai201203China

Antibody-drug conjugates(ADCs)are commonly heterogeneous and require extensive assessment of exposure-efficacy and exposure-safety relationships in preclinical and clinical *** this study,we report the generation of a monoclonal antibody against monomethyl auristatin E(MMAE)and the development,validation,and application of sensitive and high-throughput enzyme-linked immunosorbent assays(ELISA)to measure the concentrations of MMAE-conjugated ADCs and total antibodies(tAb,antibodies in ADC plus unconjugated antibodies)in cynomolgus monkey *** assays were successfully applied to in vitro plasma stability and pharmacokinetic(PK)studies of SMADC001,an MMAE-conjugated ADC against trophoblast cell surface antigen 2(TROP-2).The plasma stability of SMADC001 was better than that of similar ADCs coupled with PEG4-Val-Cit,Lys(m-dPEG24)-Cit,and Val-Cit *** developed ELISA methods for the calibration standards of ADC and tAb revealed a correlation between serum concentrations and the OD450 values,with R2 at 1.000,and the dynamic range was 0.3-35.0 ng/mL and 0.2-22.0 ng/mL,respectively;the intra-and inter-assay accuracy bias%ranged from -12.2% to -5.2%,precision ranged from -12.4% to -1.4%,and the relative standard deviation(RSD)was less than 6.6% and 8.7%,*** total error was less than 20.4%.The development and validation steps of these two assays met the acceptance criteria for all addressed validation parameters,which suggested that these can be applied to quantify MMAE-conjugated ADCs,as well as in PK ***,these assays can be easily adopted for development of other similar immunoassays.

关键词： Monomethyl auristatin E Antibody-drug conjugates Pharmacokinetics Trophoblast cell surface antigen 2

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ACE2-targeting monoclonal antibody as potent and broad-spectrum coronavirus blocker

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Signal Transduction and Targeted Therapy 2021年第9期6卷 2897-2905页

作者： Yuning Chen Ya-Nan Zhang Renhong Yan Guifeng Wang Yuanyuan Zhang Zhe-Rui Zhang Yaning Li Jianxia Ou Wendi Chu Zhijuan Liang Yongmei Wang Yi-Li Chen Ganjun Chen Qi Wang Qiang Zhou Bo Zhang Chunhe Wang Biotherapeutics Discovery Research Center Shanghai Institute of Materia MedicaChinese Academy of SciencesShanghaiChina University of Chinese Academy of Sciences BeijingChina Key Laboratory of Special Pathogens and Biosafety Wuhan Institute of VirologyCenter for Biosafety Mega-ScienceChinese Academy of SciencesWuhanHubeiChina Center for Infectious Disease Research Westlake Laboratory of Life Sciences and BiomedicineKey Laboratory of Structural Biology of Zhejiang ProvinceSchool of Life SciencesWestlake Universityand Institute of BiologyWestlake Institute for Advanced StudyHangzhouZhejiangChina Beijing Advanced Innovation Center for Structural Biology Tsinghua-Peking Joint Center for Life SciencesSchool of Life SciencesTsinghua UniversityBeijingChina School of Chinese Materia Medica Nanjing University of Chinese MedicineNanjingJiangsuChina dartsbio pharmaceuticals ZhongshanGuangdongChina Drug Discovery Center for Infectious Disease Nankai UniversityTianjinChina Fudan University School of PharmacyShanghaiChina

The evolution of coronaviruses,such as SARS-CoV-2,makes broad-spectrum coronavirus preventional or therapeutical strategies highly sought *** we report a human angiotensin-converting enzyme 2(ACE2)-targeting monoclonal antibody,3E8,blocked the S1-subunits and pseudo-typed virus constructs from multiple coronaviruses including SARS-CoV-2,SARS-CoV-2 mutant variants(SARS-CoV-2-D614G,B.1.1.7,B.1.351,B.1.617.1,and P.1).

关键词： ACE2 monoclonal prevention

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