IGNX001 / IgGenix - LARVOL DELTA

IGNX-T1: Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001 (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: IgGenix Australia Pty Ltd | Active, not recruiting ➔ Completed

Trial completion • Allergy • Food Hypersensitivity • Immunology

IGNX-T1: Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001 (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: IgGenix Australia Pty Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Allergy • Food Hypersensitivity • Immunology

Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics of IGNX001 in Peanut-Allergic (PA) Adults and Older Adolescents - Day 8 Safety Data for Cohort 1 of the ACCELERATE Peanut Study (EAACI 2025) - P1 | "Conclusion A single dose of IGNX001 had acceptable short-term safety in this population. Based on these results, Cohort 2, dosed with 300 mg IGNX001, was initiated."

Clinical • PK/PD data • Food Hypersensitivity • Immunology

IGNX-T1: Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001 (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: IgGenix Australia Pty Ltd | N=24 ➔ 32

Enrollment change • Allergy • Food Hypersensitivity • Immunology

New approaches in childhood IgE-mediated food allergy treatment. (PubMed, Curr Opin Allergy Clin Immunol) - "The portfolio of available treatment options for food allergies is increasing but several relevant unmet needs remain. This review aims to provide a brief overview of the existing and future treatment options for IgE-mediated food allergies."

Journal • Allergy • Food Hypersensitivity • Immunology • Transplantation

IgGenix Announces First Patient Dosed in Phase 1 Clinical Trial 'ACCELERATE Peanut' Evaluating IGNX001 in Peanut Allergy (PRNewswire) - "IgGenix, Inc...announced today the first patient dosed in its ACCELERATE Peanut Phase 1 clinical trial. The trial aims to evaluate IGNX001, a novel therapeutic candidate developed using IgGenix's proprietary SEQ SIFTER platform, in patients with peanut allergy. Designed to neutralize the most clinically important peanut allergens and epitopes, IGNX001 represents a novel approach to combat peanut allergies by blocking the allergic cascade....'We look forward to reporting topline data in mid-2025 and progressing IGNX001 through the clinic.'"

P1 data • Trial status • Allergy • Immunology

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001 (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: IgGenix Australia Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Allergy • Food Hypersensitivity • Immunology

Preclinical efficacy of peanut-specific IgG4 antibody therapeutic IGNX001. (PubMed, J Allergy Clin Immunol) - "We developed a peanut-specific IgG4 antibody therapeutic with convincing preclinical efficacy starting from a large repertoire of human monoclonal IgE antibodies from demographically and geographically diverse individuals. These results warrant further clinical investigation of IGNX001 and underscore the opportunity for the application of this therapeutic development strategy in other food and environmental allergies."

Journal • Preclinical • Allergy • Food Hypersensitivity • Immunology

IgGenix Demonstrates Potential of IGNX001 as a Targeted Therapeutic for Peanut Allergy at the 2024 EAACI Annual Meeting Ahead of Clinical Trial Launch (PRNewswire) - "IgGenix, Inc...presented data on the company's lead candidate, IGNX001....The company also presented data in Atopic Dermatitis (AD), showcasing the widespread utility of its proprietary SEQ SIFTER™ antibody discovery platform in IgE-mediated disease beyond allergies. These data were presented during the 2024 European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting, which took place in Valencia, Spain on May 31 – June 3, 2024....Peanut-specific therapeutic candidate, IGNX001, demonstrated potent inhibition of peanut-mediated mast cell degranulation, providing a case study of how this assay could serve as a valuable pharmacodynamic marker in clinical trials. IgGenix's proprietary SEQ SIFTER platform enables discovery of IgE antibodies involved in atopic diseases including AD."

Preclinical • Atopic Dermatitis • Food Hypersensitivity • Immunology

IGNX001 Inhibits Peanut-Mediated Mast Cell Activation in a Translational Spike-In Assay (EAACI 2024) - "Conclusion A preclinical translational spike-in MAT was developed to recapitulate the time dependent concentration of an IgG4-based antibody therapeutic in circulation. IGNX001, which competitively inhibits IgE interaction with allergen, demonstrated potent inhibition of cellular activation and provided a case study of how this assay could serve as a valuable pharmacodynamic marker in clinical trials."

Allergy • Food Hypersensitivity • Immunology

IGNX001 Inhibits Peanut-Mediated Mast Cell Activation in a Translational Spike-In Assay (EAACI 2024) - "Conclusion A preclinical translational spike-in MAT was developed to recapitulate the time dependent concentration of an IgG4-based antibody therapeutic in circulation. IGNX001, which competitively inhibits IgE interaction with allergen, demonstrated potent inhibition of cellular activation and provided a case study of how this assay could serve as a valuable pharmacodynamic marker in clinical trials."

Allergy • Food Hypersensitivity • Immunology

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001 (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: IgGenix Australia Pty Ltd

New P1 trial • Allergy • Food Hypersensitivity • Immunology