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

Award Number: R43AI186801
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/14/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2028

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $299,936 )
2026	2026	APPLIED BIOTECHNOLOGY INSTITUTE INC	1 GRAND AVE BLDG 83-1D	SAN LUIS OBISPO	CA	93407	SAN LUIS OBISPO	USA	Allergy and Infectious Diseases Research	000	1	8/14/2026	NEW	$299,936
														Subtotal = $299,936

Grand Total All Awards = $299,936

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

Award Number: R43AI186801

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/14/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2028

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