Products and developments

COVID-19

Anti-SARS-CoV-2 polyclonal hyperimmune serum (CoviFab®)  

It is an immunotherapy based on equine polyclonal antibodies (EpAbs) with high neutralizing capacity against the SARS-CoV-2 virus.

These EpAbs, which block the virus’ entry into the cells preventing viral replication, are obtained using as an antigen the recombinant receptor-binding domain of the viral Spike glycoprotein produced by biotechnology. The generated antibodies are processed to obtain highly purified F(ab')2 fragments with an excellent safety profile. EpAbs recognize and bind to different regions of the RBD domain of Spike protein blocking the sites of interaction with its human receptor, which reduces the risk of lack of efficacy against new antigenic variants. In addition, EpAbs are relatively quick to produce on large scale.

(1) “Development of a Hyperimmune Equine Serum Therapy for COVID-19 in Argentina”. Zylberman, V., et al. Medicina (Buenos Aires) 2020; Vol. 80 (Supl. III): 1-6.

(2) “RBD-specific polyclonal F(ab´)2 fragments of equine antibodies in patients with moderate to severe COVID-19 disease: A randomized, multicenter, double-blind, placebo-controlled, adaptive phase 2/3 clinical trial”. G. Lopardo et al. EClinicalMedicine, 34 (2021) 100843.

(3) “Safety and effectiveness of RBD-specific polyclonal equine F(ab´)2 fragments for the treatment of hospitalized patients with severe Covid-19 disease: A retrospective cohort study”. Farizano Salazar DH, Achinelli F, Colonna M, Pérez L, Giménez AA, et al. (2022). PLOS ONE 17(9): e0274796. https://doi.org/10.1371/journal.pone.0274796

CoviFab®

Download prospectus
Distribution: Laboratorio Elea

Hemolytic uremic syndrome

Hemolytic uremic syndrome (HUS) is caused by consuming food or water contaminated with Shiga toxin (Stx)-producing Escherichia coli bacteria (STEC). The accumulation of this toxin in children’s body causes serious effects. Initially, it may cause diarrhea with or without blood, severe abdominal pain, paleness and scant urine.

It is a rare disease and no licensed specific therapy is presently available for human use. The protocols recommend supportive therapy in a hospital setting.

icono de adulto mayor

Children are most likely to be affected but adults can get it as well.

icono de insuficiencia renal

It is the first cause of acute renal failure in children.

icono de transplante de riñones

It causes 20% of the kidney transplant in children.

It leaves sequels for life in 50% of the affected children: chronic kidney failure, hypertension and neurological disorders.

icono de niños

According to the OMS, Argentina has the highest global incidence of HUS in children under 5 years of age. Other countries in North America, Europe, or Asia have outbreaks of the disease.

icono de test de laboratorio

It can be diagnosed by a laboratory test that detects the toxin’s presence in few hours.

Investigational treatment for HUS

We developed an innovative biological drug (INM004) with the potential of becoming the first treatment to block Shiga toxin and avoid severe forms of hemolytic uremic syndrome. INM004 contains F(ab’)2 fragments of specific polyclonal antibodies against Stx. These antibodies have the advantage of being broad-spectrum: they recognize and neutralize different variants of Shiga toxin.

They were carried out at Centro de Medicina Comparada of the Instituto de Ciencias Veterinarias del Litoral (dependent on the Universidad Nacional del Litoral and the CONICET) and at specialized laboratories in the United States.

It evaluated the safety, tolerance and pharmacokinetics of INM004 in healthy volunteer adults and was conducted at Hospital Italiano de Buenos Aires. The results showed an adequate safety and pharmacokinetics profile.

It will evaluate the safety and efficacy of INM004 in pediatric patients developing HUS. The Phase 2 clinical trial is starting at 15 hospitals and clinics in Argentina.

Participating centers.

The clinical development program for INM004 was backed by the Argentine regulatory authority (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica - ANMAT), the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This investigational drug obtained the Orphan Drug Designation in both Europe (EMA) and United States (FDA), where it also received the Rare Pediatric Disease Designation.

Participating centers

Buenos Aires, CABA: Hospital Italiano de Buenos Aires; Hospital General de Niños “Pedro de Elizalde”; Hospital «Prof. Dr. Juan P. Garrahan”; Clínica Zabala; Sanatorio Güemes; Hospital de Niños “Dr. Ricardo Gutiérrez”. Florencio Varela: Hospital de Alta Complejidad en Red El Cruce “Dr. Néstor Carlos Kirchner”. La Plata: Hospital de Niños “Sor María Ludovica”. Mar del Plata: Hospital Interzonal Especializado Materno Infantil “Don Victorio Tetamanti”. Bahía Blanca: Hospital Interzonal General de Agudos “Dr. José Penna”. Córdoba: Sanatorio Allende; Hospital de Niños de la Santísima Trinidad. La Pampa: Establecimiento Asistencial “Dr. Lucio Molas”. Mendoza: Hospital Pediátrico «Dr. Humberto J. Notti». Neuquén: Hospital Provincial Neuquén “Dr. Eduardo Castro Rendón”. Rosario: Sanatorio de Niños.

Buenos Aires, CABA: Hospital Italiano de Buenos Aires; Hospital General de Niños “Pedro de Elizalde”; Clínica Zabala; Sanatorio Güemes; Hospital de Niños “Dr. Ricardo Gutiérrez”. Florencio Varela: Hospital de Alta Complejidad en Red El Cruce “Dr. Néstor Carlos Kirchner”. Mendoza: Hospital Pediátrico «Dr. Humberto J. Notti». Córdoba: Sanatorio Allende. Rosario: Sanatorio de Niños. Bahía Blanca: Hospital Interzonal General de Agudos “Dr. José Penna”. La Pampa: Establecimiento Asistencial “Dr. Lucio Molas”.

More information

If you are a health professional and would like more information about this drug candidate and/or the clinical development program, we invite you to contact us at infosalud@inmunova.com.

Hantavirus

Hantaviruses are the etiologic agents of hemorrhagic fever with renal failure (HFRS) and hantavirus’ cardiopulmonary syndrome (HCPS).

In Argentina, the viral types that trigger hantavirus cardiopulmonary syndrome prevail. HCPS is a severe acute viral disease with a mortality rate of around 30%.

It is another rare disease for which there is no vaccine or specific drugs and the only available treatment is supportive therapy at a hospital setting.

The virus is transmitted by wild mice (mainly longtails) and is spread by inhalation of aerosols with viral particles from the feces or urine of infected rodents or by direct contact with them. It can also be spread between humans by air, through close contact with an infected person. 

At Inmunova we are working on the development of an antiserum against hantavirus. Using modern protein engineering techniques, we are developing polyclonal antibodies capable of neutralizing the virus and avoiding the complications associated with the disease.

Pipeline

We work to translate advanced science and innovation into therapies that have a significant impact on improving health.

Therapeutic treatments

PROOF OF CONCEPT

PRECLINICAL PHASE

PHASE 1

PHASE 2

PHASE 3

DEVELOPMENT COMPLETED. APPROVED BY REGULATORY HEALTH AUTHORITY

CoviFab® - COVID-19
INM004 - SUH
INM007- HTNV

Vaccines

INM005 - SUH
INM008- HTNV
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