anti-shiga toxin hyperimmune equine immunoglobulin F(ab')2 fragment (INM004) / Inmunova - LARVOL DELTA

Cryo-EM structures of engineered Shiga toxin-based immunogens capable of eliciting neutralizing antibodies with therapeutic potential against hemolytic uremic syndrome. (PubMed, Protein Sci) - "Additionally, we present structural evidence of the interaction between the chimeras and polyclonal Fab (pFab) fragments derived from INM004, demonstrating that the elicited neutralizing antibodies block most of the interaction surface of the toxins with their cellular receptors. These findings further validate this promising antibody-based therapy for mitigating STEC-HUS and demonstrate that the BLS-Stx1B and BLS-Stx2B chimeras are potential candidates for developing a human vaccine."

Journal • Atypical Hemolytic Uremic Syndrome • Nephrology • Renal Disease

Role of INM004 Shiga-toxin antibodies in treatment of STEC-HUS. (PubMed, Pediatr Nephrol) - No abstract available

Journal

Open-label, controlled, phase 2 clinical trial assessing the safety, efficacy, and pharmacokinetics of INM004 in pediatric patients with Shiga toxin-producing Escherichia coli-associated hemolytic uremic syndrome. (PubMed, Pediatr Nephrol) - "INM004 showed an adequate safety profile. Efficacy non-statistically significant trends suggesting a beneficial effect in the amelioration of kidney injury were observed. These results encourage the conduction of a phase 3 study of INM004 in pediatric patients with STEC-HUS."

Journal • P2 data • PK/PD data • Acute Kidney Injury • Atypical Hemolytic Uremic Syndrome • Nephrology • Pediatrics • Renal Disease

Innovative inmunotherapy: INM004 background. Past clinical trials, results (phase II trials) (ESPN 2024) - "Sponsored by CHEMO-INMUNOVA"

Clinical • P2 data

Efficacy of INM004 in Children With STEC-HUS (clinicaltrials.gov) - P3 | N=220 | Recruiting | Sponsor: Inmunova S.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Atypical Hemolytic Uremic Syndrome • Nephrology • Pediatrics

A Phase III Study to Evaluate the Efficacy of INM004 in Children With STEC-HUS (clinicaltrials.gov) - P3 | N=220 | Not yet recruiting | Sponsor: Inmunova S.A.

New P3 trial • Atypical Hemolytic Uremic Syndrome • Nephrology • Pediatrics

A phase I study to evaluate the safety, tolerance and pharmacokinetics of anti-Shiga toxin hyperimmune equine F (ab') fragments in healthy volunteers. (PubMed, Br J Clin Pharmacol) - "The results obtained in this first-in-human study support progression into the phase 2 trial in children with HUS."

Clinical • Journal • P1 data • PK/PD data • Atypical Hemolytic Uremic Syndrome • Inflammation • Pain

A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS (clinicaltrials.gov) - P2 | N=57 | Completed | Sponsor: Inmunova S.A. | Active, not recruiting ➔ Completed | N=100 ➔ 57

Enrollment change • Trial completion • Atypical Hemolytic Uremic Syndrome • Infectious Disease • Nephrology • Pediatrics • Renal Disease

Phase 2/3 Study to Evaluate PK, Safety & Efficacy of INM004 in STEC Positive Pediatric Patients for Prevention of HUS (clinicaltrials.gov) - P2/3 | N=11 | Terminated | Sponsor: Inmunova S.A. | N=396 ➔ 11 | Suspended ➔ Terminated; Due to COVID pandemia enrolment was stopped on 20March2020

Enrollment change • Trial termination • Atypical Hemolytic Uremic Syndrome • Nephrology • Pediatrics • Renal Disease

A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Inmunova S.A. | Recruiting ➔ Active, not recruiting

Enrollment closed • Atypical Hemolytic Uremic Syndrome • Infectious Disease • Nephrology • Pediatrics • Renal Disease

A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Inmunova S.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Atypical Hemolytic Uremic Syndrome • Infectious Disease • Nephrology • Pediatrics • Renal Disease

A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Inmunova S.A.

New P2 trial • Atypical Hemolytic Uremic Syndrome • Infectious Disease • Nephrology • Pediatrics • Renal Disease

Phase 2/3 Study to Evaluate PK, Safety & Efficacy of INM004 in STEC Positive Pediatric Patients for Prevention of HUS (clinicaltrials.gov) - P2/3 | N=396 | Suspended | Sponsor: Inmunova S.A. | Trial completion date: Sep 2022 ➔ Sep 2025 | Trial primary completion date: Mar 2022 ➔ Mar 2025

Trial completion date • Trial primary completion date • Atypical Hemolytic Uremic Syndrome • Nephrology • Pediatrics • Renal Disease

Phase 2/3 Study to Evaluate PK, Safety & Efficacy of INM004 in STEC Positive Pediatric Patients for Prevention of HUS (clinicaltrials.gov) - P2/3; N=396; Suspended; Sponsor: Inmunova S.A.; Recruiting ➔ Suspended

Clinical • Trial suspension • Atypical Hemolytic Uremic Syndrome • Nephrology • Pediatrics • Renal Disease

Generation of a human iPSC line, INMi004-A, with a point mutation in CRX associated with autosomal dominant Leber congenital amaurosis. (PubMed, Stem Cell Res) - "The generated iPSC line contained the congenital deletion c.695delC in exon 4 of CRX, had a normal karyotype, and was capable of differentiation into all three germ layers. This cell line represents an important tool to study the pathophysiology of CRX-associated LCA."

Journal • Gene Therapies • Genetic Disorders • Ophthalmology