Production of low-cost heat stable forms of adalimumab in maize for treatment of inflammatory bowel disease

The National Institute of Allergy and Infectious Diseases awarded Applied Biotechnology Institute Inc. $299,936 on August 14, 2026, under the Allergy and Infectious Diseases Research program to develop heat-stable forms of adalimumab produced in maize for treatment of inflammatory bowel disease.

Applied Biotechnology Institute Inc. will produce large quantities of adalimumab, a TNF-targeting therapeutic antibody, using a proprietary recombinant maize expression system. The company will generate the antibody in either fully immunoglobulin G form or as a secretory hybrid IgG/IgA variant for enhanced stabilization. Bioencapsulation within the maize matrix enables direct oral administration through feed formulated from recombinant maize flour, eliminating the need for purification and injectable delivery. Applied Biotechnology Institute Inc. will administer the maize-produced antibody to mice both orally via recombinant maize flour-based feed and in purified form through parenteral injection, then evaluate protective immune response against challenge using a mouse adoptive transfer hypothermia model dependent on human TNF.

Performance extends through July 31, 2028, with work conducted in California. This Phase I SBIR grant supports the development of low-cost, heat-stable biologics for IBD treatment, addressing the NIH's priority for therapeutics targeting autoimmune disease.

Abstract

In keeping with the NIH's stated priority for the development of therapeutics for autoimmune disease, our goal is to develop an effective and conveniently delivered antibody therapeutic for inflammatory bowel disease (IBD). Inflammatory bowel disease (IBD) is comprised of two major subtypes (crohn's disease (CD) and ulcerative colitis (UC)) and is characterized by chronic inflammation of the gastrointestinal (GI) tract. The exact etiology of IBD is unknown, but sits at the intersection of genetics, immune dysregulation, microbiome, and environmental triggers. Therapeutic antibodies have become a first line treatment for IBD and new low-cost heat stable forms of these biologics would be highly preferred. Our chosen therapeutic candidate is adalimumab, a therapeutic antibody that targets tumor necrosis factor (TNF). In order to develop adequate amounts of antibody for an effective and adequate immune response, we have established a proprietary expression system using recombinant maize. An additional advantage of maize expression is that recombinant proteins can be directly administered through the oral route rather than purified for injection, as bioencapsulation in the maize matrix provides inherent stabilization in the digestive tract. In this proposal, our goal is to produce large amounts of adalimumab in maize. This will be in either the fully IGG form or as a secretory hybrid IGG/IGA for additional stabilization. The maize produced antibody will be administered to mice orally in feed formulated from recombinant maize flour or in a parentally administered purified form. We will demonstrate that the antibody elicits a protective response against challenge in a unique mouse adoptive transfer hypothermia model dependent on human TNF.