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CD147 antibody specifically and effectively inhibits infection and cytokine storm of SARS-coV-2 and its variants delta,alpha,beta,and gamma

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Signal Transduction and Targeted Therapy 2021年第10期6卷 3142-3154页

作者： Jiejie Geng Liang Chen Yufeng Yuan Ke Wang Youchun Wang Chuan Qin Guizhen Wu Ruo Chen Zheng Zhang Ding Wei Peng Du Jun Zhang Peng Lin Kui Zhang Yongqiang Deng Ke Xu Jiangning Liu Xiuxuan Sun Ting Guo Xu Yang Jiao Wu Jianli Jiang Ling Li Kun Zhang Zhe Wang Jing Zhang Qingguo Yan Hua Zhu Zhaohui Zheng Jinlin Miao Xianghui Fu Fengfan Yang Xiaochun Chen Hao Tang Yang Zhang Ying Shi Yumeng Zhu Zhuo Pei Fei Huo Xue Liang Yatao Wang Qingyi Wang Wen Xie Yirong Li Mingyan Shi Huijie Bian Ping Zhu Zhi-Nan Chen National Translational Science Center for Molecular Medicine&Department of Cell Biology Fourth Military Medical UniversityXi'an 710032China School of Medicine Shanghai UniversityShanghai 200444China Zhongnan Hospital of Wuhan University Wuhan 430071China Division of HIV/AIDS and Sex-transmitted Virus Vaccines Institute for Biological Product ControlNational Institutes for Food and Drug Control(NIFDC)and WHO Collaborating Center for Standardization and Evaluation of BiologicalsBeijing 102629China Institute of Laboratory Animals Science Chinese Academy of Medical SciencesBeijing 100071China NHC Key Laboratory of Biosafety National Institute for Viral Disease Control and PreventionChinese Center for Disease Control and PreventionBeijing 100871China Beijing Institute of Biotechnology Beijing 100871China Department of Clinical Immunology Xijing HospitalFourth Military Medical UniversityXi'an 710032China Beijing Institute of Microbiology and Epidemiology Beijing 100071China School of Basic Medicine Fourth Military Medical UniversityXi'an 710032China jiangsu pacific meinuoke biopharmceutical co.ltd Changzhou 213022China

SARS-coV-2 mutations contribute to increased viral transmissibility and immune escape,compromising the effectiveness of existing vaccines and neutralizing *** in-depth investigation on coVID-19 pathogenesis is urgently needed to develop a strategy against SARS-coV-2 ***,we identified CD147 as a universal receptor for SARS-coV-2 and its ***,Meplazeumab,a humanized anti-CD147 antibody,could block cellular entry of SARS-coV-2 and its variants-alpha,beta,gamma,and delta,with inhibition rates of 68.7,75.7,52.1,52.1,and 62.3%at 60μg/ml,***,humanized CD147 transgenic mice were susceptible to SARS-coV-2 and its two variants,alpha and *** infected,these mice developed exudative alveolar pneumonia,featured by immune responses involving alveoli-infiltrated macrophages,neutrophils,and lymphocytes and activation of IL-17 signaling ***,we proposed that severe coVID-19-related cytokine storm is induced by a"spike protein-CD147-CyPA signaling axis":Infection of SARS-coV-2 through CD147 initiated the JAK-STAT pathway,which further induced expression of cyclophilin A(CyPA);CyPA reciprocally bound to CD147 and triggered MAPK ***,the MAPK pathway regulated the expression of cytokines and chemokines,which promoted the development of cytokine ***,Meplazumab could effectively inhibit viral entry and inflammation caused by SARS-coV-2 and its ***,our findings provided a new perspective for severe coVID-19-related ***,the validated universal receptor for SARS-coV-2 and its variants can be targeted for coVID-19 treatment.

关键词： CD147 cytokine storm

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Safety and efficacy of meplazumab in healthy volunteers and coVID-19 patients: a randomized phase 1 and an exploratory phase 2 trial

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Signal Transduction and Targeted Therapy 2021年第6期6卷 1845-1855页

作者： Huijie Bian Zhao-Hui Zheng Ding Wei Aidong Wen Zheng Zhang Jian-Qi Lian Wen-Zhen Kang Chun-Qiu Hao Jing Wang Rong-Hua Xie Ke Dong Jie-Lai Xia Jin-Lin Miao Wen Kang Guoquan Li Di Zhang Mingru Zhang Xiu-Xuan Sun Likun Ding Kui Zhang Junfeng Jia Jin Ding Zhiqin Li Yanyan Jia Lin-Na Liu Zhe Zhang Zhao-Wei Gao Hong Du Na Yao Qing Wang Ke Wang Jie-Jie Geng Bin Wang Ting Guo Ruo Chen Yu-Meng Zhu Li-Juan Wang Qian He Rui-Rui Yao Ying Shi Xiang-Min Yang Jian-Sheng Zhou Yi-Nan Ma Ya-Tao Wang Xue Liang Fei Huo Zhe Wang Yang Zhang Xu Yang Ye Zhang Lu-Hua Gao Ling Wang Xiao-Chun Chen Hao Tang Shuang-Shuang Liu Qing-Yi Wang Zhi-Nan Chen Ping Zhu National Translational Science Center for Molecular Medicine and Department of Cell Biology Fourth Military Medical UniversityXi'anChina Department of Clinical Immunology Xijing HospitalFourth Military Medical UniversityXi'anChina Department of Pharmacy Xijing HospitalFourth Military Medical UniversityXi'anChina Center for Infectious Diseases Tangdu HospitalFourth Military Medical UniversityXi'anChina Department of Nuclear Medicine Xijing HospitalFourth Military Medical UniversityXi'anChina department of Clinical Diagnosis Tangdu HospitalFourth Military Medical UniversityXKanChina college of Military Preventive Medicine Fourth Military Medical UniversityXi'anChina Department of Pharmaceutics Tangdu HospitalFourth Military Medical UniversityXi'anChina Department of Pathology Fourth Military Medical UniversityXi'anChina jiangsu pacific meinuoke Biopharmaceutical co.ltd ChangzhouChina Department of Foreign Languages Fourth Military Medical UniversityXi'anChina

Recent evidence suggests that CD147 serves as a novel receptor for severe acute respiratory syndrome coronavirus 2(SARS-coV-2)*** CD147 via anti-CD147 antibody could suppress the in vitro SARS-coV-2 *** is a humanized anti-CD147 IgG_(2) monoclonal antibody,which may effectively prevent SARS-coV-2 infection in coronavirus disease 2019(coVID-19)***,we conducted a randomized,double-blinded,placebo-controlled phase 1 trial to evaluate the safety,tolerability,and pharmacokinetics of meplazumab in healthy subjects,and an open-labeled,concurrent controlled add-on exploratory phase 2 study to determine the efficacy in coVID-19 *** phase 1 study,59 subjects were enrolled and assigned to eight cohorts,and no serious treatment-emergent adverse event(TEAE)or TEAE grade≥3 was *** serum and peripheral blood Cmax and area under the curve showed non-linear pharmacokinetic *** obvious relation between the incidence or titer of positive anti-drug antibody and dosage was observed in each *** biodistribution study indicated that meplazumab reached lung tissue and maintained>14 days stable with the lung tissue/cardiac blood-pool ratio ranging from 0.41 to *** the exploratory phase 2 study,17 coVID-19 patients were enrolled,and 11 hospitalized patients were involved as concurrent *** meplazumab treatment significantly improved the discharged(P=0.005)and case severity(P=0.021),and reduced the time to virus negative(P=0.045)in comparison to the control *** results show a sound safety and tolerance of meplazumab in healthy volunteers and suggest that meplazumab could accelerate the recovery of patients from coVID-19 pneumonia with a favorable safety profile.

关键词： patients dosage phase

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Meplazumab in hospitalized adults with severe coVID-19(DEFLECT):a multicenter,seamless phase 2/3,randomized,third-party double-blind clinical trial

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Signal Transduction and Targeted Therapy 2023年第2期8卷 842-850页

作者： Huijie Bian Liang Chen Zhao-Hui Zheng Xiu-Xuan Sun Jie-Jie Geng Ruo Chen Ke Wang Xu Yang Shi-Rui Chen Si-Yu Chen Rong-Hua Xie Kui Zhang Jin-Lin Miao Jun-Feng Jia Hao Tang Shuang-Shuang Liu Hong-Wei Shi Yong Yang Xiao-Chun Chen Vinay Malhotra Nosheen Nasir Iffat Khanum Faisal Mahmood Saeed Hamid Claudio Marcel Berdun Stadnik Kengi Itinose Caroline Cândida Carvalho de Oliveira Cesar Dusilek Lucas Rivabem Adilson Joaquim Westheimer Cavalcante Suzara Souto Lopes Wladmir Faustino Saporito Fábio Joséconcilio Fucci Jesus Abraham Simon-Campos Ling Wang Lin-Na Liu Qing-Yi Wang Ding Wei Zheng Zhang Zhi-Nan Chen Ping Zhu Department of Cell Biology of National Translational Science Center for Molecular Medicine and Department of Clinical Immunology of Xijing Hospital Fourth Military Medical UniversityXi’anChina Shanghai Engineering Research Center of Organ Repair School of MedicineShanghai UniversityShanghaiChina jiangsu pacific meinuoke Biopharmaceutical co.ltd ChangzhouChina Pulse Heart Institute Cardiology Services MultiCare Institute for Research&InnovationTacomaWAUSA Department of Medicine The Aga Khan UniversityKarachiPakistan Infection control Service Irmandade Santa Casa de Misericord de Porto AlegrePorto AlegreBrazil Clinical Research Department Hospital do RocioCampo LargoBrazil CEMEC-Centro Multidisciplinar de Estudos Clínicos São Bernardo do CampoBrazil Chronos Pesquisa Clinica BrasíliaBrazil Pesquisare Saúde Santo AndréBrazil Instituto de Moléstias Cardiovasculares Tatuí TatuíBrazil Kohler&Milstein Research/Hospital Agustín O’Horán MéridaMexico college of Military Preventive Medicine Fourth Military Medical UniversityXi’anChina Department of Pharmaceutics Tangdu HospitalFourth Military Medical UniversityXi’anChina Department of Foreign Languages Fourth Military Medical UniversityXi’anChina

Meplazumab,a humanized CD147 antibody,has shown favourable safety and efficacy in our previous clinical *** DEFLECT(NCT04586153),167 patients with severe coVID-19 were enroled and randomized to receive three dosages of meplazumab and a *** at 0.12 mg/kg,compared to the placebo group,showed clinical benefits in significantly reducing mortality by 83.6%(2.4%vs.14.6%,p=0.0150),increasing the proportion of patients alive and discharged without supplemental oxygen(82.9%vs.70.7%,p=0.0337)and increasing the proportion of patients who achieved sustained clinical improvement(41.5%vs.31.7%).The response rate in the 0.2 mg/kg group was relatively increased by 16.0%compared with the placebo group(53.7%vs.46.3%).Meplazumab also reduced the viral loads and multiple cytokine *** with the placebo group,the 0.3 mg/kg significantly increased the virus negative rate by 40.6%(p=0.0363)and reduced IL-8 level(p=0.0460);the 0.2 mg/kg increased the negative conversion rate by 36.9%,and reduced IL-4(p=0.0365)and IL-8 levels(p=0.0484).In this study,the adverse events occurred at a comparable rate across the four groups,with no unexpected safety findings *** conclusion,meplazumab promoted coVID-19 convalescence and reduced mortality,viral load,and cytokine levels in severe coVID-19 population with good safety profile.

关键词： clinical mortality dosage

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