News Release
Sunday, February 25, 2024
Drug can help protect kids with multiple food allergies during accidental exposure.
A 16-week course of a monoclonal antibody, omalizumab, increased the amount of peanut, tree nuts, egg, milk and wheat that multi-food allergic children as young as 1 year could consume without an allergic reaction in a late-stage clinical trial. Nearly 67% of participants who completed the antibody treatment could consume a single dose of 600 milligrams (mg) or more of peanut protein, equivalent to 2.5 peanuts, without a moderate or severe allergic reaction, in contrast with less than 7% of participants who received placebo. The treatment yielded similar outcomes for egg, milk, wheat, cashew, walnut and hazelnut at a threshold dose of 1,000 mg protein or more. This suggests the antibody therapy has the potential to protect children and adolescents if they accidentally eat a food to which they are allergic despite efforts to avoid it, according to the investigators. The findings were presented today at the American Academy of Allergy, Asthma & Immunology Annual Meeting in Washington, D.C., and published in The New England Journal of Medicine.
People with food allergies and their caregivers need to maintain constant vigilance to avoid foods that could cause a potentially life-threatening allergic reaction. This is extremely stressful, especially for parents of young children, said Jeanne Marrazzo, M.D., M.P.H., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health and the trials regulatory sponsor. Although food avoidance remains critical, the findings reported today show that a medicine can help reduce the risk of allergic reactions to common foods and may provide protection from accidental exposure emergencies.
NIAID funds the ongoing trial with additional support from and collaboration with Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation. The two companies collaborate to develop and promote omalizumab, marketed as Xolair, and are supplying it for the trial. The National Center for Advancing Translational Sciences, also part of NIH, supports some of the staff, space and services used to conduct the trial.
An estimated 7.6% of children in the United State roughly 5.5 million kids have food allergies. On February 16, 2024, the Food and Drug Administration approved omalizumab for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adults and children aged 1 year and older with food allergy. The FDA approval was based on data from a planned interim analysis of the Phase 3 NIAID trial. People taking omalizumab still need to avoid foods they are allergic to. Omalizumab is not approved for the emergency treatment of allergic reactions, including anaphylaxis.
Previously, the only available treatment for food allergy was oral immunotherapy, or OIT, which involves daily ingestion of a specific food allergen in gradually increasing doses up to a maintenance amount.
The multi-stage trial is called Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Children and Adults, or OUtMATCH. The first stage of the study was designed to see if taking omalizumab increased the threshold for the amount of food that caused allergic reactions, thereby reducing the likelihood of reactions to small amounts of food allergens during accidental exposure.
Omalizumab works by binding to the allergy-causing antibody called immunoglobulin E in the blood and preventing it from arming key immune cells responsible for allergic reactions. This renders these cells much less sensitive to stimulation by any allergen.
The NIAID-funded Consortium for Food Allergy Research (CoFAR) is conducting OUtMATCH at 10 locations across the United States. The CoFAR has enrolled 177 children and adolescents ages 1 to 17 years and three adults ages 18 to 55 years, all with confirmed allergy to peanut and at least two other common foods among milk, egg, cashew, wheat, hazelnut or walnut.
In the first stage of the trial, people who reacted to small amounts of food allergens during oral food challenges were assigned at random to receive injections of either omalizumab or placebo. Neither the participants nor the investigators knew which food was used in a challenge nor who was in which group. After 16 to 20 weeks of injections, the participants were challenged again in a carefully controlled setting to see if they could tolerate a greater amount of food than they did at the outset. The goal was to find out if omalizumab injections led to a statistically significant increase in the proportion of participants who could consume roughly the equivalent of 2.5 peanuts without a moderate or severe allergic reaction, up from less than half a peanut at the outset, and similarly greater quantities of milk, egg or cashew among people allergic to those foods.
Investigators found that omalizumab was superior to placebo in increasing the reaction threshold for peanut, milk, egg and cashew as well as wheat, walnut and hazelnut to levels that likely would protect against allergic reactions upon accidental exposure. Seventy-nine of 118 omalizumab-treated children and adolescents, or 66.9%, could consume at least a single dose of 600 mg or more of peanut protein without a moderate or severe allergic reaction during the post-treatment challenge, in contrast with four out of 59 children and adolescents, or 6.8%, who received placebo. The researchers observed similar results for milk, egg, cashew, wheat, walnut and hazelnut at a threshold dose of 1,000 mg protein or more.
Many omalizumab-treated participants ate more than 600 mg of peanut protein without a moderate or severe allergic reaction. Sixty-seven percent consumed a cumulative dose of 1,044 mg of peanut protein, or about four peanuts, and 44% ate a cumulative dose of 6,044 mg of peanut protein, or about 25 peanuts. In addition, substantial proportions of treated participants consumed a cumulative dose of 1,044 mg of more than one food without a moderate or severe allergic reaction. Sixty-nine percent ate this amount of two foods, and 47%, three foods.
The first 60 participants who completed the first stage entered a 24-week open-label extension of omalizumab injections followed by additional oral food challenges. Most participants who had received omalizumab in the first stage maintained or increased the amount of food protein they could consume without an allergic reaction during the extension.
Robert Wood, M.D., and Sharon Chinthrajah, M.D. are leading the trial. Dr. Wood is the Julie and Neil Reinhard Professor of Pediatric Allergy and Immunology and director of the Pediatric Clinical Research Unit at the Johns Hopkins University School of Medicine. Dr. Chinthrajah is an associate professor of medicine and of pediatric allergy and clinical immunology at Stanford University School of Medicine.
Further information about the ongoing OUtMATCH trial is available at ClinicalTrials.gov under study identifier NCT03881696. The outcomes of later stages of the trial will be published in the future.
NIAID conducts and supports researchat NIH, throughout the United States, and worldwideto study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
NIHTurning Discovery Into Health
RA Wood, et al. Omalizumab for the treatment of multiple food allergy. The New England Journal of Medicine DOI: 10.1056/NEJMoa2312382. (2024).
###
Read the rest here:
Antibody reduces allergic reactions to multiple foods in NIH clinical trial - National Institutes of Health (NIH) (.gov)
- Innate Pharma Announces Publication in Science Immunology Highlighting Innovative Next-generation ANKET - Business Wire - November 20th, 2024 [November 20th, 2024]
- TRexBio Announces $84 Million Series B Financing to Advance Pipeline of First-in-Class Immunology Programs into Clinical Development - Business Wire - November 20th, 2024 [November 20th, 2024]
- Discovering Solutions for Long COVID: A T-Cell Immunology Breakthrough - Infection Control Today - November 20th, 2024 [November 20th, 2024]
- Innate Pharma Announces Publication in Science Immunology Highlighting Innovative Next-generation ANKET IPH6501 - The Bakersfield Californian - November 20th, 2024 [November 20th, 2024]
- Immunology Data Shows INOVIO's INO-3107 Induced Expansion of New Clonal T Cells That Infiltrate Airway Tissue and Correspond With Reduction of... - November 20th, 2024 [November 20th, 2024]
- What it's like in allergy and immunology: Shadowing Dr. Fraser - American Medical Association - November 12th, 2024 [November 12th, 2024]
- Dr. Naba Sharif Elected President of the New Jersey Allergy Asthma and Immunology Society - Newswire - November 12th, 2024 [November 12th, 2024]
- Department of Microbiology and Immunology Named a National Milestones Program - Stony Brook News - October 26th, 2024 [October 26th, 2024]
- Astria Therapeutics to Present at Upcoming American College of Allergy, Asthma, and Immunology Annual Scientific Meeting - businesswire.com - October 26th, 2024 [October 26th, 2024]
- Remembering immunology educator, researcher Tom McDonald, PhD - University of Nebraska Medical Center - October 13th, 2024 [October 13th, 2024]
- Systems immunology approaches to study T cells in health and disease - Nature.com - October 13th, 2024 [October 13th, 2024]
- Leading the charge to discover answers in immunology - The University of Arizona - October 2nd, 2024 [October 2nd, 2024]
- New mouse models offer valuable window into COVID-19 infection - La Jolla Institute for Immunology - October 2nd, 2024 [October 2nd, 2024]
- Wide-Moat AbbVie Poised for Growth, Driven by Innovation in Immunology Beyond Humira - Morningstar - October 2nd, 2024 [October 2nd, 2024]
- Lilly's immunology unit scores another FDA nod with eczema treatment Ebglyss - FiercePharma - September 23rd, 2024 [September 23rd, 2024]
- Huang Named Head Of Pathology And Immunology - Mirage News - September 15th, 2024 [September 15th, 2024]
- Huang named head of pathology & immunology - Washington University School of Medicine in St. Louis - September 15th, 2024 [September 15th, 2024]
- Apogee Therapeutics to Participate at the Stifel 2024 Immunology and Inflammation Summit - Yahoo Finance - September 15th, 2024 [September 15th, 2024]
- Eliem Therapeutics to Participate at the Stifel 2024 Virtual Immunology and Inflammation Summit - StockTitan - September 15th, 2024 [September 15th, 2024]
- UCLA receives $120 million from Alya and Gary Michelson for new California Institute for Immunology and Immunotherapy - UCLA Newsroom - September 2nd, 2024 [September 2nd, 2024]
- Boosting vaccines for the elderly with 'hyperactivators' - Boston Children's Answers - Boston Children's Discoveries - June 27th, 2024 [June 27th, 2024]
- Immunologists Want You to Know These Dust Mite Allergy Facts - Yahoo Lifestyle UK - June 27th, 2024 [June 27th, 2024]
- How Ragon Institute's new building aids its mission Harvard Gazette - Harvard Gazette - June 27th, 2024 [June 27th, 2024]
- Insights into CRS and NPs: Visual and Bibliometric Analysis - Physician's Weekly - June 27th, 2024 [June 27th, 2024]
- Biogen joins immunology wave with $1.15 billion acquisition of HI-Bio - STAT - May 24th, 2024 [May 24th, 2024]
- Biogen Buys Desired Growth In Immunology With $1.15bn Hi-Bio Deal - Scrip - May 24th, 2024 [May 24th, 2024]
- Biogen Boosts Immunology Portfolio with $1.8 Billion Acquisition of HI-Bio - BioPharm International - May 24th, 2024 [May 24th, 2024]
- Owkin Unveils AI-Driven Oncology and Immunology Pipeline, In-Licenses Best-in-Class Asset OKN4395 - Yahoo Finance - May 24th, 2024 [May 24th, 2024]
- Biogen to expand immunology and rare disease portfolio with $1.8bn HI-Bio acquisition - PMLiVE - May 24th, 2024 [May 24th, 2024]
- Astria Therapeutics to Present at Upcoming European Academy of Allergy and Clinical Immunology Congress - Business Wire - May 24th, 2024 [May 24th, 2024]
- Biogen to buy Human Immunology Biosciences in deal worth up to $1.8B - MM+M Online - May 24th, 2024 [May 24th, 2024]
- COVID-19 Re-Vaccinations Elicit Neutralizing Antibodies Against Future Variants - Technology Networks - May 24th, 2024 [May 24th, 2024]
- HIV Vaccine Candidate Induces Broadly Neutralizing Antibodies in Humans - Technology Networks - May 24th, 2024 [May 24th, 2024]
- Pasteur Fiocruz Center on Immunology and Immunotherapy is inaugurated in Cear - Fiocruz - May 24th, 2024 [May 24th, 2024]
- Biogen to buy Human Immunology Biosciences in up to $1.8 billion deal - Marketscreener.com - May 24th, 2024 [May 24th, 2024]
- Fellow Focus in Four: Marat Kribis, MD, Rheumatology, Allergy and Immunology - Yale School of Medicine - April 15th, 2024 [April 15th, 2024]
- Long COVID Can Now Be Detected in the Blood - Technology Networks - April 15th, 2024 [April 15th, 2024]
- Rimjhim Agarwal selected as Major Symposium speaker at the American Association of Immunologists ... - La Jolla Institute for Immunology - March 29th, 2024 [March 29th, 2024]
- Seeking new horizons: Where innovators find opportunities in a fast-changing immunology landscape - IQVIA - March 29th, 2024 [March 29th, 2024]
- Researchers identify new way to inhibit immune cells that drive allergic asthma - EurekAlert - March 29th, 2024 [March 29th, 2024]
- Innovation in Oncology and Cancer Immunology Research - Boehringer Ingelheim - March 29th, 2024 [March 29th, 2024]
- Measles outbreaks show the risk of under-vaccination | News | Harvard T.H. Chan School of Public Health - HSPH News - March 29th, 2024 [March 29th, 2024]
- Immunology-oncology ELISA Kits Market to Witness a Healthy Growth by 2030 - WhaTech - March 29th, 2024 [March 29th, 2024]
- Spring Allergy Season Is Getting Worse. Here's What to Know. - The New York Times - March 29th, 2024 [March 29th, 2024]
- Multiple sclerosis has distinct subtypes, study finds, pointing to different treatments - STAT - March 29th, 2024 [March 29th, 2024]
- Researchers identify viable vaccine targets for hepatitis C infections - News-Medical.Net - March 29th, 2024 [March 29th, 2024]
- Three research projects awarded funding from the Immunology Institute Pilot Project program - University of Alabama at Birmingham - February 29th, 2024 [February 29th, 2024]
- Deal Watch: AbbVie Adds To Immunology Pipeline Through Deal With OSE - Scrip - February 29th, 2024 [February 29th, 2024]
- AbbVie and Tentarix Announce Collaboration to Develop Conditionally-Active, Multi-Specific Biologics for Oncology ... - PR Newswire - February 29th, 2024 [February 29th, 2024]
- Integrating single-cell multi-omics and prior biological knowledge for a functional characterization of the immune system - Nature.com - February 29th, 2024 [February 29th, 2024]
- Renowned immunologist and four-decade UAB researcher Max Cooper, M.D., will deliver this year's Marx Lecture - University of Alabama at Birmingham - February 29th, 2024 [February 29th, 2024]
- Inactivation of TGF- signaling in CAR-T cells | Cellular & Molecular Immunology - Nature.com - February 29th, 2024 [February 29th, 2024]
- Babies use their immune system differently but efficiently | Cornell Chronicle - Cornell Chronicle - February 29th, 2024 [February 29th, 2024]
- Mestag Therapeutics Enlists Leading Cancer Biology and Immunology Advisors to Support Clinical Development of its ... - GlobeNewswire - February 21st, 2024 [February 21st, 2024]
- Theratechnologies announces publication in Frontiers in Immunology on TH1902 - TipRanks.com - TipRanks - February 21st, 2024 [February 21st, 2024]
- Smoking has long-term effects on the immune system - Institut Pasteur - February 21st, 2024 [February 21st, 2024]
- Spring Allergies Attack More Than Just Your Nose - ACAAI Public Website - American College of Allergy Asthma and Immunology - February 21st, 2024 [February 21st, 2024]
- Theratechnologies Announces Publication in Frontiers in Immunology that Deepens Understanding of Sudocetaxel ... - GlobeNewswire - February 21st, 2024 [February 21st, 2024]
- Shikhar Mehrotra named co-leader of Cancer Biology and Immunology research program at MUSC Hollings - The Cancer Letter - January 27th, 2024 [January 27th, 2024]
- Gut Microbiome Benefits of Breast Milk Revealed in Mouse Study - Technology Networks - January 27th, 2024 [January 27th, 2024]
- Research on Immunological Diseases Launches with Hungarian Participation - Hungary Today - January 27th, 2024 [January 27th, 2024]
- UCLA to turn former shopping mall into centers for research on immunology and quantum science - The Associated Press - January 8th, 2024 [January 8th, 2024]
- TRexBio Announces a First Option Was Exercised by Partner under Immunology Discovery Collaboration - Business Wire - January 8th, 2024 [January 8th, 2024]
- UCLA to turn former Westside Pavilion into centers for research on immunology and quantum science - KABC-TV - January 8th, 2024 [January 8th, 2024]
- HI-Bio Announces $95 Million Series B Financing to Advance Targeted Therapies for Immune-Mediated Diseases - PR Newswire - January 8th, 2024 [January 8th, 2024]
- Beyond Cytotoxicity: The Importance of T Cell Memory - The Scientist - January 8th, 2024 [January 8th, 2024]
- IKAROS: Unlocking the secrets of the immune system's key player - News-Medical.Net - January 8th, 2024 [January 8th, 2024]
- UCLA to turn former shopping mall into centers for research on immunology and quantum science - The Caledonian-Record - January 8th, 2024 [January 8th, 2024]
- Revolutionizing Vaccine Research: The Power of a New Algorithm - SciTechDaily - December 31st, 2023 [December 31st, 2023]
- Impact of the gut microbiome on immunological responses to COVID-19 vaccination in healthy controls and people ... - Nature.com - December 22nd, 2023 [December 22nd, 2023]
- Two new practice parameters offer recommendations for treating anaphylaxis and atopic dermatitis - News-Medical.Net - December 22nd, 2023 [December 22nd, 2023]
- Physician and Patient (Un)Wellness in Allergy and Immunology During COVID-19 and Beyond: Lessons for the Future - Physician's Weekly - December 22nd, 2023 [December 22nd, 2023]
- Researchers Identify Why Some Cancers Do Not Respond to Immunotherapy - NYU Langone Health - December 22nd, 2023 [December 22nd, 2023]
- MU's Haval Shirwan recognized for achievements in immunology - Columbia Daily Tribune - December 22nd, 2023 [December 22nd, 2023]
- Parker Institute for Cancer Immunotherapy (PICI) Welcomes Weill Cornell Medicine to Cancer Research Consortium - Weill Cornell Medicine Newsroom - December 14th, 2023 [December 14th, 2023]
- Annals of Allergy, Asthma and Immunology Examines Effects of Climate Change on Allergic Conditions - Newswise - December 14th, 2023 [December 14th, 2023]
- British Society for Immunology response to the NHS vaccination strategy - British Society for Immunology | - December 14th, 2023 [December 14th, 2023]
- NYU Langone Health in the NewsFriday, December 8, 2023 - NYU Langone Health - December 14th, 2023 [December 14th, 2023]
- Arturo Casadevall Named Distinguished Fellow by the American Association of Immunologists - Johns Hopkins Bloomberg School of Public Health - December 14th, 2023 [December 14th, 2023]
- ImmunoScape Appoints Systems Immunology and Computational Biology Expert Dr. John Tsang to its Scien - PharmiWeb.com - December 14th, 2023 [December 14th, 2023]