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Out of Nowhere
Published in Rae-Ellen W. Kavey, Allison B. Kavey, Viral Pandemics, 2020
Rae-Ellen W. Kavey, Allison B. Kavey
On a more focused level, development of effective treatment methods is a very high priority. In September 2014, the World Health Organization launched a fast-track process to identify potential anti-Ebola drugs with four potential classes of products: immunomodulators, immunoglobulins, small inhibitory RNA, and antivirals.154 Three criteria were established for a drug to be acceptable as a candidate for clinical trials: available safety data in humans, evidence for in-vivo efficacy against Ebola virus from preclinical studies, and sufficient drug supply.155 Five potential drugs were identified: Favipiravir, an RNA polymerase inhibitor, originally developed and approved in Japan for the treatment of severe influenza; mAb114, a chimeric monoclonal antibody cocktail; Remdesivir, a novel nucleotide analog prodrug developed for treatment of filovirus infections that blocks replication; REGN3470-3471–3479, a co-formulated cocktail of three human monoclonal antibodies targeting the EBOV glycoprotein; and ZMapp, a triple monoclonal antibody cocktail, already tried in selected cases during the 2014–2015 epidemic that targets three Ebola glycoprotein epitopes.
Review of Ebola virus disease in children – how far have we come?
Published in Paediatrics and International Child Health, 2021
Devika Dixit, Kasereka Masumbuko Claude, Lindsey Kjaldgaard, Michael T. Hawkes
MAb114. The single-dose therapy MAb114 is derived from a single antibody recovered from the blood of a survivor of EVD in the Kikwit, DRC outbreak in 1995 [86,95]. In a phase I dose escalation study in 18 healthy adults, MAb114 showed favourable safety and tolerability [95]. It was easy to administer by IV infusion and had a pharmacokinetic profile allowing it to be given as a single dose [94,95]. In the PALM study, Mab114 was administered to 174 EVD patients, including 26 children <5 and 29 children and youths aged 5–18 years. Mortality in the MAb114 group was 35% which was statistically lower than in the ZMapp control group (aOR 0.24, 95% CI 0.10–0.61). There were no infusion reactions and mild systemic symptoms were reported in only four of 18 (22%) patients [95]. In a multivariable model, the effect of Mab114 remained significant after adjustment for age (aOR 0.52, 95%CI 0.33–0.82) [68].
Potent neutralizing monoclonal antibodies against Ebola virus isolated from vaccinated donors
Published in mAbs, 2020
Pengfei Fan, Xiangyang Chi, Guodong Liu, Guanying Zhang, Zhengshan Chen, Yujiao Liu, Ting Fang, Jianmin Li, Logan Banadyga, Shihua He, Changming Yu, Xiangguo Qiu, Wei Chen
EBOV has caused dozens of outbreaks, but the scale of the last two outbreaks has far exceeded the previous ones. Indeed, EBOV, and related viruses, continue to pose a threat to global public health, and they continue to be prime candidates for the development of biological weapons.36 Meanwhile, new EBOV-like filoviruses are still being discovered.2,37 All these factors underscore the importance of developing preventive and therapeutic agents. Although the vaccine Ervebo (Merck) was recently approved by the FDA to prevent EVD caused by EBOV in adults,38 there remains no clinically approved post-exposure therapeutic. Antibodies have good pharmacokinetics, specificity, and tolerability, and represent promising potential therapeutics for a number of viral diseases, including those caused by filoviruses. Indeed, two antibody treatments, REGN-EB3 and mAb114, have recently been shown to significantly improve patient survival in a clinical trial undertaken during the ongoing EBOV outbreak in the Democratic Republic of the Congo,39 highlighting the potential for antibodies to be effective treatments against filoviruses.