Maleki’s and Cheng’s complementary expertise and contributions were integral to this pioneer breakthrough in oral immunotherapy for food allergies, ushering in a new era of possibility.

In partnership with Allergen Research Corp. (later Aimmune Therapeutics), Soheila J. Maleki, PhD, and Hsiaopo Cheng developed an oral immunotherapy treatment for peanut allergy sufferers. Their collaboration led to the pharmaceutical Palforzia®, an oral immunotherapy treatment for peanut allergy sufferers — and the first food-allergy treatment approved by the Food and Drug Administration (FDA). Before FDA approval in 2020, most people with peanut allergies had only one option to prevent reactions: avoid peanuts. In 2012, the CEO of then-startup Allergen Research Corporation recruited Maleki and Cheng to help produce a standardized pharmaceutical-grade peanut flour for the treatment. Technology transfer officers worked with the small research team at the Agricultural Research Service (ARS) to create a material transfer and research agreement with Aimmune Therapeutics, who also assisted in funding the research and providing the materials and financial support to advance the research. The scientist team at ARS specializes in the effects of heat treatments such as roasting on individual peanut allergens. 

Maleki, lead scientist of food allergy research at the U.S. Department of Agriculture’s ARS-Southern Regional Research Center, is known worldwide as an expert on the effects of processing on peanut allergens; her research involves developing methods for purification, characterization and detection of allergic proteins in differently processed food, particularly peanut and tree nuts. Maleki was responsible for understanding how peanut and tree nut allergens are structured, how they function and why they trigger an allergic reaction in some people and not others. Cheng, a support scientist in the Food Processing and Sensory Quality Research Unit, is an expert in developing methods to improve detection, diagnostics and therapeutics for peanut and tree nut allergy. With their work, the team developed a pharmaceutical grade roasted peanut flour that patients take orally in increasing doses to desensitize their peanut allergy.  

Maleki and Cheng developed methods to purify peanut allergens and use them to produce specific antibodies to detect these allergens. They then developed methods to detect, quantify, and characterize peanut allergens in peanut flour products under various conditions. Their methods and reagents were validated by Aimmune Therapeutics and adopted as standards in their pharmaceutical product, Palforzia®, the peanut allergy treatment. Palforzia® is the only food that has been FDA-approved for marketing and prescription by physicians. Furthermore, the protocols and methods the ARS team developed open the door for similar oral treatments for food allergies.