Compositions and Methods for Preventing Allergies Engineering Animal Tissues to Avoid the Alpha-Gal Trigger

This patent describes compositions and methods for preventing or reducing the risk and severity of allergic reactions to a carbohydrate epitope, focused particularly on alpha-gal syndrome (AGS), an emerging tick-borne food allergy that produces severe reactions to mammalian meat and to medical products derived from non-human mammals.

The Problem

In the United States alone, more than 50 million people live with at least one diagnosed allergy, and food allergies in particular have been rising. Among them, alpha-gal syndrome is a relatively new and rapidly expanding clinical entity. AGS is triggered in many patients by a bite from the Lone Star tick (Amblyomma americanum) and similar species, after which the patient develops an IgE response to galactose-alpha 1,3-galactose, a sugar carried on the cells of most non-primate mammals. Once sensitised, an AGS patient can have anaphylactic reactions to red meat, dairy, gelatin-containing medications, certain biologics, porcine and bovine implants, and even surgical materials. Avoidance is the standard of care but is impractical: alpha-gal hides in many products consumers and clinicians do not associate with mammalian origin. The clinical and quality-of-life burden has been growing in tick-endemic regions of Europe, Australia and the United States.

What This Invention Does

The invention provides compositions, derived from animals engineered to lack alpha-gal, and methods for using those compositions to prevent or reduce the risk of an allergic reaction to alpha-gal in sensitised subjects. By removing the alpha-gal epitope at its source, the resulting biological materials, whether food-grade tissues, surgical implants, biologic precursors, or other animal-derived products, no longer present the trigger that AGS patients react to. The patent also covers methods of producing such compositions, providing a path to scalable supply.

The disclosed work touches several adjacent application areas: tissue grafts and bioprosthetics that today are commonly sourced from porcine or bovine tissue and that can be intolerable for AGS patients; food-system applications where alpha-gal-free meat or dairy could become a defined allergy-safe category; and pharmaceutical excipients or biologic substrates where alpha-gal contamination is a known concern.

Key Features

• Alpha-gal-eliminated source material. Compositions derived from animals engineered to no longer present the alpha-gal epitope on their cells.
• Allergy-prevention indication. Designed to prevent or reduce the risk and severity of allergic reactions to alpha-gal in sensitised subjects, including those with diagnosed AGS.
• Multi-application scope. Applicable across food-grade tissues, surgical and tissue-engineering implants, and pharmaceutical materials of animal origin.
• Methods of production. Covers the methods of making the alpha-gal-eliminated compositions, supporting a defensible supply chain.
• Clinical relevance to a growing patient population. Directly addresses an allergy population that is expanding as the geographic range of trigger ticks expands.

Who Is Behind It?

The applicant is Revivicor, Inc., a US biotechnology company specialising in genetically modified pigs for biomedical applications. Revivicor is best known publicly for producing the alpha-gal-knockout pigs used in landmark xenotransplantation experiments, including the first pig-to-human heart transplants. The named inventors are John Bianchi, David Ayares, Anneke Walters and Amy Dandro, longstanding members of Revivicor’s technical leadership. The Australian application is a divisional of AU 2019359400, with US provisional priority from US 62/744,061 filed in October 2018.

Why It Matters

Alpha-gal syndrome is no longer a clinical curiosity. Australia is one of the regions where the syndrome is increasingly recognised, alongside the United States and Europe. Beyond the food side of the problem, alpha-gal contamination in animal-derived medical products is a quietly significant clinical issue: heart valves, soft-tissue patches, biologic materials, even some vaccine excipients are sourced from mammals. Owning the IP behind a verified alpha-gal-free production system gives Revivicor a defensible position across food, surgical materials, and the rapidly developing field of xenotransplantation. The Australian filing protects the technology in a market where AGS is recognised and where regulators have begun to engage with the wider implications of alpha-gal exposure.

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AU 2026201820 was published in the Australian Official Journal of Patents on 2 April 2026 and is open for public inspection. Patent applications represent inventions that are sought to be protected and do not necessarily reflect commercially available products.