IgGenix Announces First Patient Dosed in Phase 1 Clinical Trial "ACCELERATE Peanut" Evaluating IGNX001 in Peanut Allergy

Novel SEQ SIFTER™ discovery platform used to re-engineer original human IgE antibodies into IgG antibodies to block binding and protect against peanut allergen

Topline data expected in mid-2025

SOUTH SAN FRANCISCO, Calif., Oct. 16, 2024 /PRNewswire/ -- IgGenix, Inc., a clinical-stage biotechnology company pioneering innovative treatments for immune mediated diseases, 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 are thrilled to announce the initiation of our ACCELERATE Peanut Phase 1 clinical trial and the dosing of our first participant," said Jessica Grossman MD, CEO of IgGenix. "IGNX001 embodies years of rigorous research and development, and this milestone marks an important step toward validating our mechanism of action in allergy treatment. Preclinical data have demonstrated the potential of IGNX001 to have greater impact for patients living with peanut allergy, particularly through its expected rapid onset of action, improved safety profile, and less frequent subcutaneous injection schedule. We look forward to reporting topline data in mid-2025 and progressing IGNX001 through the clinic."

The ACCELERATE Peanut Phase 1 trial is a randomized, multi-center, double-blind, placebo-controlled, single ascending dose study designed to assess the safety, tolerability, and potential proof of mechanism of IGNX001 in peanut-allergic individuals. Targeting both adults and older adolescents (ages 15 to 18), the study will enroll approximately 24 participants who have been diagnosed with peanut allergies. Details of the study can be found at https://clinicaltrials.gov/study/NCT06331728.

"For individuals with peanut allergies, there is a constant risk of severe, potentially life-threatening allergic reactions creating significant physical, social, and emotional burdens. The novel mechanism of action of IGNX001 is an exciting development, and I'm hopeful that IGNX001 has the potential to revolutionize how individuals manage their peanut allergy by reducing their risk of anaphylaxis," stated Dr. Andrew Carr, DSc MD MBBS FRACP FRCPA, Senior Staff Specialist, Immunology and HIV Unit, Senior Staff Specialist in Immunopathology, St Vincent's Hospital, Sydney and Professor of Medicine, UNSW Sydney.

This Phase 1 trial represents the inaugural program in IgGenix's pipeline. Should IGNX001 prove successful, it will not only provide a promising solution for peanut allergies but also pave the way for the application of IgGenix's technology to other types of food allergies and allergic diseases.

About IgGenix

IgGenix is a privately held antibody discovery and development company taking a revolutionary approach to directly address allergies and atopic diseases. Through our proprietary SEQ SIFTER™ discovery platform, developed from foundational research of co-founders Stephen Quake, Kari Nadeau, and Derek Croote of Stanford University, we isolate and re-engineer fully human, high-affinity, allergen-specific antibodies designed to block and prevent the allergic cascade. By targeting common immunodominant allergens and their most important epitopes across the patient population, we intend to treat allergic pediatric and adult patients alike across food and environmental allergies. This novel approach may prevent life-threatening allergic reactions, saving lives and reducing the constant fear that affects millions of people living with severe allergies.

SOURCE IgGenix