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First-in-human study of two anti-SARS CoV-2 antibodies in health volunteers

对健康志愿者中的两种抗 SARS CoV-2 抗体进行的首次人体研究

基本信息

批准号：
10291661
负责人：
Luis J Montaner
金额：
$ 157.16万
依托单位：
WISTAR INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-02-23 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10291661
关键词：
2019-nCoV Amino Acid Substitution Amino Acids Animal Model Animals Antibodies Antibody Therapy Antigens Antiviral Agents Asparagine Binding Biological COVID-19 COVID-19 pandemic Clinical Data Disease Dose Drug Kinetics Economics Elderly Exhibits FDA Emergency Use Authorization Fc domain Grant Half-Life Hamsters Health Healthcare Human Activities Immune Immune response Immunocompromised Host In Vitro Individual Infection Intravenous Intravenous infusion procedures Leucine Methionine Modernization Monoclonal Antibodies Mus Mutation Outcome Participant Pathology Pattern Phase Play Population Populations at Risk Positioning Attribute Prevention Prophylactic treatment Randomized Controlled Trials Recombinants Resistance Resolution Role SARS-CoV-2 antibody SARS-CoV-2 infection SARS-CoV-2 spike protein Safety Sanitation Serine Site Sterility Subcutaneous Injections Therapeutic Universities Vaccination Vaccines Variant Viral World Health clinical candidate clinical development convalescent plasma design experimental study first-in-human healthy volunteer high risk human monoclonal antibodies human study in vitro activity in vivo neutralizing monoclonal antibodies nonhuman primate open label pandemic disease phase 1 study phase I trial pre-clinical pressure prevent receptor binding research clinical testing severe COVID-19 subcutaneous volunteer

项目摘要

Project Summary The Coronavirus Disease 2019 (COVID-19) pandemic is currently gripping the world without a known cure or prevention. Aside from the health consequences, the necessary decrease in human activity has resulted in economic losses without modern precedent, especially in the developing world where health care and sanitation were not sufficient even prior to the pandemic. Innumerable efforts are being undertaken to develop vaccines to SARS-CoV-2 and it is likely that antibodies will be essential for protection. COVID-19 antibody therapy in the form of polyclonal plasma from convalescent individuals is currently being explored as a therapeutic option and has been granted an emergency use authorization (EUA) by the FDA. Monoclonal antibodies may prove to be particularly useful in preventing SARS-CoV-2 infection in populations who may not mount protective immune responses to vaccination (e.g. advanced age, immunocompromise) and for post-exposure prophylaxis in individuals at high risk to develop severe COVID-19. C135 and C144 are recombinant, fully human mAbs that specifically bind SARS-CoV-2 spike protein receptor binding domain (RBD) and exhibit exceptional neutralizing activity in vitro against SARS-CoV-2. Two one-amino acid mutations have been introduced to prolong half-life and allow dose sparing. The C135-LS and C144-LS combination has shown remarkable activity in both prophylaxis and therapy experiments in several relevant animal models in both prophylaxis and treatment experiments. These preclinical data support the clinical evahe from SARS-CoV-2 and accelerate viral clearance and disease resolution in SARS-CoV-2-infected individuals. The proposed study is a first-in-human, open label, single dose, dose-escalation phase 1 trial to evaluate the safety and pharmacokinetics of the C135-LS and C144-LS combination in healthy volunteers.

项目总结

项目成果

期刊论文数量（24）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Host Immune Responses in HIV-1 Infection: The Emerging Pathogenic Role of Siglecs and Their Clinical Correlates.

DOI：
10.3389/fimmu.2017.00314
发表时间：
2017
期刊：
Frontiers in immunology
影响因子：
7.3
作者：
Mikulak J;Di Vito C;Zaghi E;Mavilio D
通讯作者：
Mavilio D

Measuring replication competent HIV-1: advances and challenges in defining the latent reservoir.

DOI：
10.1186/s12977-018-0404-7
发表时间：
2018-02-13
期刊：
Retrovirology
影响因子：
3.3
作者：
Wang Z;Simonetti FR;Siliciano RF;Laird GM
通讯作者：
Laird GM

Cell-Mediated Immunity to Target the Persistent Human Immunodeficiency Virus Reservoir.

针对持续性人类免疫缺陷病毒库的细胞介导的免疫。

DOI：
10.1093/infdis/jix002
发表时间：
2017
期刊：
The Journal of infectious diseases
影响因子：
0
作者：
Riley,JamesL;Montaner,LuisJ
通讯作者：
Montaner,LuisJ

Ultrasensitive antigen density discrimination by synNotch.

通过 synNotch 进行超灵敏抗原密度辨别。

DOI：
10.1038/s41422-021-00511-y
发表时间：
2021
期刊：
Cell research
影响因子：
44.1
作者：
Shukla,Divanshu;Riley,JamesL
通讯作者：
Riley,JamesL

Susceptibility to 3BNC117 and 10-1074 in ART suppressed chronically infected persons.

ART 中对 3BNC117 和 10-1074 的敏感性抑制了慢性感染者。

DOI：
10.1097/qad.0000000000003575
发表时间：
2023
期刊：
AIDS (London, England)
影响因子：
0
作者：
Tebas,Pablo;Lynn,Kenn;Azzoni,Livio;Cocchella,Giorgio;Papasavvas,Emmanouil;Fair,Matthew;Karanam,Brijesh;Sharma,Paridhima;Reeves,JacquelineD;Petropoulos,ChristosJ;Lalley-Chareczko,Linden;Kostman,JayR;Short,William;Mounzer,Karam
通讯作者：
Mounzer,Karam