[Translation] Phase I clinical trial of tolerability/safety and pharmacokinetics of recombinant anti-Ebola virus monoclonal antibody combined injection in healthy subjects

评价单次给予重组抗埃博拉病毒单克隆抗体联合注射液在健康成人的耐受性/安全性及药代动力学特征，为其II期和III期临床试验给药剂量和给药方案的确定提供科学依据。

[Translation]

To evaluate the tolerability/safety and pharmacokinetic characteristics of a single dose of recombinant anti-Ebola virus monoclonal antibody combination injection in healthy adults, and to provide a scientific basis for determining the dosage and dosing regimen for its Phase II and Phase III clinical trials.

Start Date22 Nov 2019

Sponsor / Collaborator

Zhejiang Hisun Pharmaceutical Co., Ltd.

[+2]

100 Clinical Results associated with MIL-77

100 Translational Medicine associated with MIL-77

100 Patents (Medical) associated with MIL-77

Literatures (Medical) associated with MIL-77

01 Apr 2017·Antimicrobial Agents and ChemotherapyQ2 · MEDICINE

Chemically Modified Human Serum Albumin Potently Blocks Entry of Ebola Pseudoviruses and Viruslike Particles

Q2 · MEDICINE

Article

Author: Yu, Yufeng ; Lv, Ming ; Jiang, Shibo ; Xia, Shuai ; Wang, Qian ; Wang, Yan ; Yu, Fei ; Lu, Lu ; Li, Haoyang

ABSTRACT Ebola virus (EBOV), the causative pathogen of the deadly Ebola virus disease (EVD), can be transmitted via contact with EVD patients, including sexual contact with EVD survivors. At present, no licensed vaccine or therapeutic is available. In this study, we compared eight anhydride-modified proteins for their entry-inhibitory activity against the pseudovirus (PsV) carrying the envelope glycoprotein (GP) of the EBOV Zaire or Sudan species (Zaire PsV and Sudan PsV, respectively). We found that 3-hydroxyphthalic anhydride-modified human serum albumin (HP-HSA) was the most effective in inhibiting the entry of both Zaire PsV and Sudan PsV, with the 50% effective concentration being at the nanomolar level and with HP-HSA being more potent than EBOV-neutralizing antibody MIL77-2 (4G7, a component antibody of the ZMapp drug cocktail). The combination of HP-HSA and MIL77-2 exhibited a synergistic effect. HP-HSA had no obvious in vitro or in vivo toxicity. The EBOV PsV entry-inhibitory activity of HP-HSA remained intact after storage at 45°C for 8 weeks, suggesting that HP-HSA has the potential for worldwide use, including tropical regions in African countries, as either a therapeutic to treat EBOV infection or a prophylactic microbicide to prevent the sexual transmission of EBOV.

Nature CommunicationsQ1 · CROSS-FIELD

Prior vaccination with rVSV-ZEBOV does not interfere with but improves efficacy of postexposure antibody treatment

Q1 · CROSS-FIELD

ArticleOA

Author: Prasad, Abhishek N ; Agans, Krystle N ; Zeitlin, Larry ; Geisbert, Thomas W ; Melody, Kevin ; Deer, Daniel J ; Feldmann, Heinz ; Fenton, Karla A ; Sprecher, Armand ; Borisevich, Viktoriya ; Bornholdt, Zachary A ; Geisbert, Joan B ; Cross, Robert W

AbstractA replication-competent vesicular stomatitis virus vaccine expressing the Ebola virus (EBOV) glycoprotein (GP) (rVSV-ZEBOV) was successfully used during the 2013-16 EBOV epidemic. Additionally, chimeric and human monoclonal antibodies (mAb) against the EBOV GP have shown promise in animals and humans when administered therapeutically. Uncertainty exists regarding the efficacy of postexposure antibody treatments in the event of a known exposure of a recent rVSV-ZEBOV vaccinee. Here, we model a worst-case scenario using rhesus monkeys vaccinated or unvaccinated with the rVSV-ZEBOV vaccine. We demonstrate that animals challenged with a uniformly lethal dose of EBOV one day following vaccination, and then treated with the anti-EBOV GP mAb MIL77 starting 3 days postexposure show no evidence of clinical illness and survive challenge. In contrast, animals receiving only vaccination or only mAb-based therapy become ill, with decreased survival compared to animals vaccinated and subsequently treated with MIL77. These results suggest that rVSV-ZEBOV augments immunotherapy.

Scientific ReportsQ3 · CROSS-FIELD

Treatment with hyperimmune equine immunoglobulin or immunoglobulin fragments completely protects rodents from Ebola virus infection

Q3 · CROSS-FIELD

ArticleOA

Author: Gai, Weiwei ; Zheng, Ying ; Wong, Gary ; Li, Yuetao ; Yan, Feihu ; Wang, Tiecheng ; Chi, Hang ; Yang, Songtao ; Gao, Yuwei ; Huang, Geng ; Wang, Chong ; Cao, Zengguo ; Xia, Xianzhu ; Qian, Jun ; He, Shihua ; Fan, Quanshui ; Kobinger, Gary ; Wang, Hualei ; Zou, Yong ; Li, Nan ; Jin, Hongli ; Gao, George Fu ; Feng, Na ; Chen, Weijin ; Zhao, Yongkun ; Qiu, Xiangguo ; Zheng, Xuexing ; Chu, Di ; Bi, Yuhai

AbstractRecent successes with monoclonal antibody cocktails ZMappTM and MIL77 against Ebola virus (EBOV) infections have reignited interest in antibody-based therapeutics. Since the production process for monoclonal antibodies can be prolonged and costly, alternative treatments should be investigated. We produced purified equine antisera from horses hyperimmunized with EBOV virus-like particles, and tested the post-exposure efficacy of the antisera in a mouse model of infection. BALB/c mice were given up to 2 mg of purified equine antisera per animal, at 30 minutes, 1 or 2 days post-infection (dpi), in which all animals survived. To decrease the possibility of serum sickness, the equine antisera was digested with pepsin to generate F(ab′)2 fragments, with in vitro neutralizing activity comparable to whole immunoglobulin. Full protection was achieved with when treatment was initiated at 1 dpi, but the suboptimal protection observed with the 30 minute and 2 dpi groups demonstrate that in addition to virus neutralization, other Fc-dependent antibody mechanisms may also contribute to survival. Guinea pigs given 20 mg of antisera or F(ab′)2 at or starting at 1 or 2 dpi were also fully protected from EBOV infection. These results justify future efficacy studies for purified equine products in NHPs.

100 Deals associated with MIL-77

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhagic Fever, Ebola	Phase 1	CN	Beijing Mabworks Biotech Co., Ltd.	22 Nov 2019
Hemorrhagic Fever, Ebola	Phase 1	CN	Chinese PLA Academy of Military Medical Sciences	22 Nov 2019
Hemorrhagic Fever, Ebola	Phase 1	CN	Zhejiang Hisun Pharmaceutical Co., Ltd.	22 Nov 2019

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