IgGenix has announced the dosing of the first patient in its Phase 1 ACCELERATE Peanut clinical trial, marking a significant step in the development of IGNX001, a monoclonal antibody-based therapeutic for peanut allergy. The trial aims to evaluate the safety, tolerability, and mechanism of action of IGNX001 in patients aged 15 years and older.
IGNX001: A Novel Approach to Peanut Allergy
IGNX001 is designed to neutralize peanut proteins by attaching to them, preventing them from interacting with allergy cells in the body. According to Jessica Grossman, MD, CEO of IgGenix, IGNX001 is an IgG4 antibody that binds to specific proteins in peanuts. "If a person is allergic to peanut and ingests peanut, the antibody should act like a heat-seeking missile to find that peanut, attach to that peanut and neutralize it so that peanut can’t interact with the allergy cells that are in a peanut-allergic patient’s body," Grossman explained.
This mechanism differs from existing treatments like Palforzia, an oral immunotherapy that desensitizes patients by administering small doses of peanut allergen, and Xolair, an antibody therapeutic that targets IgE antibodies to reduce overall allergic response.
ACCELERATE Peanut Phase 1 Trial Details
The ACCELERATE Peanut trial is a randomized, multi-center, double-blind, placebo-controlled study with a single ascending dose design. The primary endpoint is safety, measured by adverse events and abnormalities in lab results or clinical signs. Secondary endpoints include pharmacokinetics and the development of anti-drug antibodies. The trial also incorporates pharmacodynamic markers, including patient reactions to an oral peanut challenge at a 4-week time point.
The trial involves three dose levels, with patients receiving a single dose of IGNX001 and being monitored weekly for 12 weeks. The study is being conducted at four centers in Australia, chosen for their efficient research and development tax incentives and high-quality immunologists.
Timeline and Recruitment
Recruitment for the trial is ongoing, with topline data expected in June or July 2025. The trial focuses on individuals aged 15 to 55, an age group often overlooked in allergy trials. IgGenix emphasizes the importance of addressing the needs of adult patients who may face severe reactions and have limited treatment options.
Addressing an Unmet Need
IgGenix aims to provide a protective solution for individuals with peanut allergies, moving beyond avoidance strategies and epinephrine autoinjectors. "One of the big challenges with peanut allergy is peanuts are a low-cost source of protein," Grossman noted, highlighting the presence of hidden peanut allergens in various food products. The company envisions IGNX001 as a preventative measure, offering immediate protection against accidental peanut exposure. Animal studies have shown complete protection within days of injection, a result IgGenix hopes to replicate in humans.
