Cure8 regulatory brief
If successful, this approach could lower costs and simplify storage/transport of an established IBD antibody (adalimumab) and enable oral delivery, which would be relevant to people with Crohn’s disease or ulcerative colitis who use biologic therapies.
Researchers in biologics and plant-based expression systems, clinicians treating IBD with biologics, and patients who use or cannot access injectable anti-TNF therapies.
This is a funded NIH project record describing efforts to produce adalimumab in maize as a low-cost, heat-stable, orally deliverable therapeutic for IBD.
The proposal plans to express adalimumab in recombinant maize (either full IgG or secretory IgG/IgA forms), administer maize-produced antibody orally in feed or as a purified parenteral preparation in mice, and test protective effects in a human-TNF–dependent mouse model.
This entry is a project record (funded research) describing planned experiments in mice and production methods; it does not report clinical trial results in humans. Plant-produced, orally delivered antibodies face challenges including dose control, regulatory pathway, and clinical efficacy/safety testing in humans.
Review the original publication for the complete reporting, methods, and context.
Funding disclosed by the source: National Institute of Allergy and Infectious Diseases - R43AI186801 - $299,936
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
The article summarizes recent drug approvals and Phase 3 trial results that could affect which biologic treatments are available and how the Crohn's disease treatment market may change. It also gives epidemiology and...
This trial is testing whether adding vedolizumab after autologous stem cell transplant can improve remission rates for people with severe Crohn's disease that has failed multiple therapies.
Patients on anti-TNF biologics often seek safe ways to support gut microbial health. This trial tests a prebiotic supplement (2'-FL) for safety and whether it increases beneficial bacteria and butyrate in young people...
