A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study with Single Blind Sentinel Period to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IGNX001 in Peanut-Allergic Participants

The goal of this randomized, double-blind, placebo-controlled, single ascending dose clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IGNX001 in peanut-allergic adults and older Adolescents.

开始日期2024-09-01

申办/合作机构

IgGenix, Inc.初创企业

100 项与 IGNX-001 相关的临床结果

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100 项与 IGNX-001 相关的转化医学

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100 项与 IGNX-001 相关的专利（医药）

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项与 IGNX-001 相关的文献（医药）

2024-07-01·Journal of Allergy and Clinical Immunology

Preclinical efficacy of peanut-specific IgG4 antibody therapeutic IGNX001

Article

作者: O'Konek, Jessica J ; Lowman, Henry B ; Thomas, G Roger ; Wong, Joyce J W ; Creeks, Paige ; Landers, Jeffrey J ; Santos, Alexandra F ; Aruva, Venu ; Kwok, Matthew ; Jama, Zainab ; Hamilton, Robert G ; Croote, Derek ; Ferrini, Roger

BACKGROUNDExisting therapeutic strategies are challenged by long times to achieve effect and often require frequent administration. Peanut-allergic individuals would benefit from a therapeutic that provides rapid protection against accidental exposure within days of administration while carrying little risk of adverse reactions.OBJECTIVEGuided by the repertoire of human IgE mAbs from allergic individuals, we sought to develop a treatment approach leveraging the known protective effects of allergen-specific IgG4 antibodies.METHODSWe applied our single-cell RNA-sequencing SEQ SIFTER platform (IgGenix, Inc, South San Francisco, Calif) to whole blood samples from peanut-allergic individuals to discover IgE mAbs. These were then class-switched by replacing the IgE constant region with IgG4 while retaining the allergen-specific variable regions. In vitro mast cell activation tests, basophil activation tests, ELISAs, and an in vivo peanut allergy mouse model were used to evaluate the specificity, affinity, and activity of these recombinant IgG4 mAbs.RESULTSWe determined that human peanut-specific IgE mAbs predominantly target immunodominant epitopes on Ara h 2 and Ara h 6 and that recombinant IgG4 mAbs effectively block these epitopes. IGNX001, a mixture of 2 such high-affinity IgG4 mAbs, provided robust protection against peanut-mediated mast cell activation in vitro as well as against anaphylaxis upon intragastric peanut challenge in a peanut allergy mouse model.CONCLUSIONSWe developed a peanut-specific IgG4 antibody therapeutic with convincing preclinical efficacy starting from a large repertoire of human IgE mAbs 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.

项与 IGNX-001 相关的新闻（医药）

2024-09-02

·PRNewswire

IgGenix Presents Data Supporting Clinical Development of IGNX001 for Peanut Allergy at the 2024 ASCIA Annual Conference

SOUTH SAN FRANCISCO, Calif., Sept. 2, 2024 /PRNewswire/ -- IgGenix, Inc., a preclinical antibody discovery and development company taking a revolutionary approach to address IgE-mediated diseases, presented exciting data on the company's lead candidate, IGNX001, an IgG4 monoclonal antibody-based therapeutic for peanut allergy. These data were presented during the 2024 Annual Conference of the Australasian Society of Clinical Immunology and Allergy (ASCIA), taking place in Adelaide, Australia from September 3-6, 2024. Highlights from ASCIA Michael O'Sullivan, MBBS, FRACP, FRCPA, lead investigator, presented information on IgGenix's Phase 1 human clinical trial in peanut allergy "ACCELERATE Peanut." This study, which is active and screening, will evaluate the safety and tolerability of IGNX001, a therapeutic candidate which aims to offer the potential of rapid protection for peanut allergic patients. Derek Croote PhD, chief technology officer and co-founder of IgGenix, presented preclinical data on IGNX001 demonstrating robust protection against peanut-mediated mast cell activation, as well as against anaphylaxis in a murine model of peanut allergy. The complete preclinical findings were recently published in The Journal of Allergy and Clinical Immunology. "IGNX001 marks a potentially major step forward in treating peanut allergies," said Michael O'Sullivan, MBBS, FRACP, FRCPA, Consultant Clinical Immunologist at Fiona Stanley Hospital and Perth Children's Hospital, and Clinical Senior Lecturer at the University of Western Australia. "By using cutting edge research to re-engineer harmful IgE antibodies to IgG4 blocking antibodies that bind to allergens without causing reactions, this approach offers the potential for a faster, more effective alternative to current therapies. It has the potential to help change peanut allergy management, reducing severe reaction risks and improving quality of life for millions worldwide." Oral Presentation Title: Accelerating Towards Treatment Options for Adolescents and Adults With Peanut Allergy: Phase 1 Trial of Peanut-Specific Igg4 Antibody Therapeutic (IGNX001) Presenter: Michael O'Sullivan, MBBS, FRACP, FRCPA Poster Presentation Title: Preclinical Activity and GLP Safety Toxicology Data Ahead of Phase 1 Initiation of IGNX001 in Peanut Allergy Presenter: Derek Croote, PhD The abstracts can be accessed here. 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

免疫疗法临床1期ASCO会议AACR会议临床结果

2024-06-03

·PRNewswire

IgGenix Demonstrates Potential of IGNX001 as a Targeted Therapeutic for Peanut Allergy at the 2024 EAACI Annual Meeting Ahead of Clinical Trial Launch

Additional data presented showcased the expansive potential of the SEQ SIFTER™ platform in the discovery and characterization of IgE antibodies in Atopic Dermatitis SOUTH SAN FRANCISCO, Calif., June 3, 2024 /PRNewswire/ -- IgGenix, Inc., a preclinical antibody discovery and development company taking a revolutionary approach to address IgE-mediated diseases, presented data on the company's lead candidate, IGNX001, an IgG4 monoclonal antibody-based therapeutic candidate for peanut allergy. 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. Highlights from EAACI: 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. "At IgGenix, we're developing revolutionary treatments for peanut and other severe allergies. These therapeutics are designed to offer an appealing alternative for allergic patients that want protection against allergen exposure in a matter of days instead of months," said Derek Croote, Ph.D., Chief Technical Officer of IgGenix. "Our pioneering SEQ SIFTER discovery platform is also unlocking IgE biology in an unprecedented way and we are excited to be working with our fantastic European collaborators on this new direction." IgGenix will be launching its first human clinical trial in peanut allergy later this year. Oral Presentations: Title: IGNX001 Inhibits Peanut-Mediated Mast Cell Activation in a Translational Spike-In Assay Authors: Croote D., Bachmeier-Zbären N., Eggel A., Thomas GR., Lowman HB. Presenter: Derek Croote, Ph.D., IgGenix Title: Discovery of Monoclonal IgE Autoantibodies from Atopic Dermatitis Patients Authors: Croote D., Wen Wong JJ., Aruva V., Creeks P., Badloe F., Grossman J., Thomas GR., Lowman HB., Gutermuth J., Kortekaas-Krohn I. Presenter: Derek Croote, Ph.D., IgGenix The abstracts can be accessed here. 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

免疫疗法临床研究

100 项与 IGNX-001 相关的药物交易

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