Zylberman Vanesa, Sanguineti Santiago, Pontoriero Andrea V, Higa Sandra V, Cerutti María L, Morrone Seijo Susana M, Pardo Romina, Muñoz Luciana, Acuña Intrieri María E, Alzogaray Vanina A, Avaro Martín M, Benedetti Estefanía, Berguer Paula M, Bocanera Laura, Bukata Lucas, Bustelo Marina S, Campos Ana M, Colonna Mariana, Correa Elisa, Cragnaz Lucía, Dattero María E, Dellafiore María, Foscaldi Sabrina, González Joaquín V, Guerra Luciano L, Klinke Sebastián, Labanda María S, Lauché Constanza, López Juan C, Martínez Anabela M, Otero Lisandro H, Peyric Elías H, Ponziani Pablo F, Ramondino Romina, Rinaldi Jimena, Rodríguez Santiago, Russo Javier E, Russo Mara L, Saavedra Soledad L, Seigelchifer Mauricio, Sosa Santiago, Vilariño Claudio, López Biscayart Patricia, Corley Esteban, Spatz Linus, Baumeister Elsa G, Goldbaum Fernando A
Inmunova S.A., San Martín, Provincia de Buenos Aires, Argentina.
Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Argentina.
Medicina (B Aires). 2020;80 Suppl 3:1-6.
The disease named COVID-19, caused by the SARS-CoV-2 coronavirus, is currently generating a global pandemic. Vaccine development is no doubt the best long-term immunological approach, but in the current epidemiologic and health emergency there is a need for rapid and effective solutions. Convalescent plasma is the only antibody-based therapy available for COVID-19 patients to date. Equine polyclonal antibodies (EpAbs) put forward a sound alternative. The new generation of processed and purified EpAbs containing highly purified F(ab')2 fragments demonstrated to be safe and well tolerated. EpAbs are easy to manufacture allowing a fast development and scaling up for a treatment. Based on these ideas, we present a new therapeutic product obtained after immunization of horses with the receptor-binding domain of the viral Spike glycoprotein. Our product shows around 50 times more potency in in vitro seroneutralization assays than the average of convalescent plasma. This result may allow us to test the safety and efficacy of this product in a phase 2/3 clinical trial to be conducted in July 2020 in the metropolitan area of Buenos Aires, Argentina.
由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引起的2019冠状病毒病（COVID-19）目前正在全球范围内大流行。疫苗研发无疑是最佳的长期免疫方法，但在当前的流行病学和卫生紧急情况下，需要快速有效的解决方案。恢复期血浆是迄今为止唯一可用于COVID-19患者的基于抗体的疗法。马源多克隆抗体（EpAbs）提供了一个合理的替代方案。新一代经过加工和纯化的EpAbs含有高度纯化的F(ab')2片段，已证明是安全且耐受性良好的。EpAbs易于生产，能够快速开发并扩大规模用于治疗。基于这些想法，我们展示了一种新的治疗产品，该产品是用病毒刺突糖蛋白的受体结合域对马进行免疫后获得的。我们的产品在体外血清中和试验中的效力比恢复期血浆的平均效力高约50倍。这一结果可能使我们能够在2020年7月于阿根廷布宜诺斯艾利斯大都市区进行的2/3期临床试验中测试该产品的安全性和有效性。
