De qué se trata el suero terapéutico argentino que neutraliza el coronavirus (SARS-Cov-2)

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Con una estrategia similar a la del plasma de convalecientes, apunta a dar una respuesta mientras el sistema inmune del paciente actúa. Una de sus responsables dialogó con Ámbito y detalló que su ventaja es la capacidad de ser producido a gran escala.

En tiempos en que laciencia  se propone actuar contrarreloj y necesita de aportes de diferentes actores para afrontar la pandemia de Covid -19, este miércoles se anunció un avance prometedor que espera aún probarse en humanos: 

un suero terapéutico 100% argentino para tratar pacientes infectados con coronavirus mostró, en pruebas in vitro, la capacidad de neutralizar el virus SARS-CoV-2.

Se trata de un suero anti-COVID-19 para inmunización pasiva – es decir, la estrategia de administrar anticuerpos contra el agente infeccioso para evitar que se propague- basado en anticuerpos policlonales equinos, que se obtienen mediante la inyección de una proteína recombinante del SARS-CoV-2 en caballos, inocua para ellos, pero que les permite la capacidad de generar gran cantidad de anticuerpos capaces de neutralizar el virus.

Nuevo avance contra el Covid-19

Mientras se espera la vacuna, que implica tiempos más extensos de desarrollos, en actualidad se evalúa otro método de inmunización pasiva: la aplicación de plasma de convalecientes, reservado a pacientes graves o con comorbilidades debido a que es escaso. De probarse la eficacia de este método, la principal ventaja sería producir una respuesta similar en quienes lo necesitan, solo que con la capacidad de poder ser producido a gran escala y así llegar a más personas.

Este avance, que espera ser probado en ensayos clínicos en breve, es fruto del trabajo de articulación público-privada encabezado por el laboratorio Inmunova (del Grupo Insud) y el Instituto Biológico Argentino (BIOL), la Administración Nacional de Laboratorios e Institutos de Salud “Dr. Carlos G. Malbrán” (ANLIS), con la colaboración de la Fundación Instituto Leloir (FIL), Mabxience, CONICET y la Universidad Nacional de San Martín (UNSAM).

El proyecto fue uno de los seleccionados por la convocatoria “Ideas Proyecto Covid-19” y está enmarcado dentro de las acciones que el Ministerio de Ciencia, Tecnología e Innovación (MINCyT), el CONICET y la Agencia Nacional de Promoción de la Investigación, el Desarrollo Tecnológico y la Innovación, llevan a cabo a través de la “Unidad Coronavirus Covid-19”.

Ámbito dialogó con la doctora Vanesa Zylverman, directora Técnica de Inmunova e invesgigadora del Conicet, quien brindó todos los detalles de esta prometedora estrategia que apunta a “darle un respiro y tiempo al sistema inmunológico de cada paciente para que comience a actuar”.

El equipo completo desarrollador de este avance, que bloqueó al coronavirus SARS-Cov-2 en pruebas in vitro.

El equipo completo desarrollador de este avance, que bloqueó al coronavirus SARS-Cov-2 en pruebas in vitro.Inmunova

Periodista: ¿Desde cuándo trabajan en este suero hiperinmune obtenido de anticuerpos equinos?

Vanesa Zylberman: Desde que comenzó la pandemia y empezamos a comprender que la tecnología que manejábamos en el laboratorio podía ser ampliamente utilizada para colaborar a que se resuelva la situación generada por la pandemia, mientras esperamos la llegada de una vacuna, que sería la solución ideal.

P.: ¿Qué se logró in vitro y cuándo arrancan los estudios clínicos en humanos?

V.Z.: Hemos probado el suero en el sistema in vitro -es decir, fuera del cuerpo de un animal o de una persona – que son los primeros ensayos para comprobar si un suero es potente o no. Los resultados mostraron que hemos logrado inhibir la capacidad del virus de infectar una célula humana. En presencia de nuestro antisuero, el SARS-CoV-2 no fue capaz de ingresar dentro de ella y ese bloqueo nos da el indicio de que podría ser beneficioso probarlo en humanos. Pero antes de comenzar, debemos tener el aval de las entidades regulatorias. Estamos en el paso de la presentación de las documentación necesaria como para que la ANMAT comience a verificar los resultados que obtuvimos y le de curso a la primera fase de investigación clínica.

P.: ¿Qué significa inmunización pasiva y cómo se diferencia de la activa?

V.Z.: A la hora de defendernos de cualquier patógeno, dentro de la inmunidad hay varias opciones. La inmunidad activa es cuando a una persona le inyectan una sustancia que activa su sistema inmunológico para generar los anticuerpos suficientes como para que si hubiese algún segundo contacto con un patógeno, ya se cuente con una armadura. (Es decir, las vacunas preventivas). La inmunidad pasiva ocurre cuando a un paciente se le da directamente los anticuerpos y sirve cuando la persona está enferma, tiene una toxina en su cuerpo y necesita combatirla en el momento, sin necesidad de esperar que el sistema inmunológico monte su propia respuesta. Se llama pasiva porque no se activa la respuesta del paciente sino que se administran anticuerpos de una fuente exógena (persona o animal, después de purificarlos) para bloquear lo que pase al paciente en el momento en que se lo administra. Esta estrategia también se usa mucho cuando alguien presenta una toxina por picadura de alacrán o venenos de diferentes tipos y se necesita bloquear sus efectos con urgencia. También se usa en cáncer para reconocer y matar las células tumorales. Y puede usarse en enfermedades virales.

P: ¿Cuál fue el proceso de obtención de estos anticuerpos y por qué eligieron equinos?

V.Z.: Los anticuerpos equinos se usan hace muchísimo tiempo en la medicina y no son directamente del caballo al ser humano sino que pasan por un proceso muy complejo de purificación antes de ser aptos. Cabe aclarar que el caballo no recibe el virus, sino solamente recibe una pequeña molécula que está en la superficie del virus y así, monta una respuesta contra esa pequeña porción. Tras purificarse, esos anticuerpos están dirigidos contra esa región del virus, que es su área fundamental para que el SARS-CoV-2 pueda entrar a la célula. Y si ahí se produce el bloqueo, es fácil suponer que el virus no encuentre donde infectar.

P.: ¿Qué es la proteína Spike?

V.Z.: Como paso previo y a raíz de muchos datos bibliográficos, nosotros identificamos en el laboratorio, que hay una parte de la proteína que se encuentra en la membrana del virus y que se ve como corona. Esa es la proteína Spike, que a la vez tienen un pedacito. Ese pedacito de la proteína Spike tiene la función de unirse al receptor humano. Lo que nosotros hicimos en el laboratorio fue producir la parte del virus que está estrechamente relacionada con su unión al receptor humano y obtuvimos a través de la inmunización con esa proteína de los caballos muchos anticuerpos que bloquean a esa parte de la molécula, con la hipótesis de que se estaría bloqueando la capacidad del virus de entrar a la célula huésped,

Inmunova

P.: ¿Cuántos voluntarios planean reclutar en los ensayos clínicos y qué pasos faltan para que el suero esté disponible?

V.Z.: Aún nos falta empezar y culminar los ensayos clínicos que demuestren su capacidad de curar. Para ello, un grupo de entre 200 y 400 voluntarios va a recibir este suero. Y no necesariamente serán pacientes en estados muy avanzados de la enfermedad. Pueden tener una infección entre leve y severa. Y se verá cuánto tiempo pasa hasta que puedan revertir el cuadro clínico. Eventualmente se tiene que activar el sistema inmunológico de los pacientes, pero con estas estrategias lo que se da es un “respiro” para bloquear el virus y dar más tiempo a la respuesta inmunitaria de cada paciente se active.

Ambito

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