IgGenix, a clinical-stage biotechnology company, announced the completion of enrollment for its Phase 1 clinical study of IGNX001, marking a significant milestone in the development of novel therapeutics for peanut allergy. The final participant in the ACCELERATE Peanut study was dosed on August 12, 2025, representing the world's first clinical trial of an antibody therapeutic specifically designed for peanut allergic individuals.
Novel Mechanism of Action
IGNX001 is a first-in-class, high-affinity, human IgG4 monoclonal antibody therapeutic engineered to prevent allergic reactions caused by accidental allergen exposure. The therapy works by blocking the binding of peanut allergens to IgE antibodies, potentially offering a safe, efficacious, and fast-acting treatment approach for peanut allergy management.
The antibody was developed using IgGenix's proprietary SEQ SIFTER™ discovery platform, which emerged from foundational research conducted by co-founders Stephen Quake, Kari Nadeau, and Derek Croote at Stanford University. This platform enables the isolation and re-engineering of fully human, high-affinity, allergen-specific antibodies designed to block and prevent the allergic cascade.
Clinical Trial Design
The ACCELERATE Peanut study is structured as a randomized, double-blind, placebo-controlled, single-ascending dose trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IGNX001 in peanut allergic individuals. This Phase 1 safety data will serve as the foundation for positioning the company for further clinical studies of this novel therapy.
"Completing enrollment in our first-in-human study is a pivotal moment for IgGenix and a significant step forward for the millions of individuals living with the daily threat of severe allergic reactions," said Jessica Grossman, M.D., Chief Executive Officer of IgGenix. "We are deeply grateful to the participants and clinical investigators whose contributions have been instrumental in advancing this important program."
Broader Therapeutic Vision
IgGenix's approach extends beyond peanut allergy treatment, targeting common immunodominant allergens and their most important epitopes across patient populations. The company's strategy aims to treat allergic pediatric and adult patients across both food and environmental allergies, potentially preventing life-threatening allergic reactions and reducing the constant fear affecting millions of people living with severe allergies.
Derek Croote, Ph.D., Chief Technical Officer of IgGenix, expressed optimism about the study's progress: "It has been an amazing team effort, and we look forward to analyzing the ACCELERATE Peanut data. We anticipate sharing topline data from this study in the coming months."
The completion of enrollment represents a critical step toward developing what could become a transformative therapeutic option for individuals with peanut allergies, addressing an unmet medical need in a population that currently relies primarily on avoidance strategies and emergency interventions.
