ArticlePlant biotechnology journal2021
Preclinical development of plant-based oral immune modulatory therapy for haemophilia B.
Article in Plant biotechnology journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
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Who cites it
23 citing papers in PubMed, 29 citations in OpenAlex.
- Trial
- Engineering Marker-Free Lettuce Chloroplast Genome to Express Functional Glucagon-Like Peptide-1 Receptor Agonists Exenatide and Lixisenatide.Plant biotechnology journal · 2026Article
- Expression of mannanase and glucanases in lettuce chloroplasts and functional evaluation of enzyme cocktail against Candida albicans in oral cancer patient samples.Plant biotechnology journal · 2025Article
- Plant molecular farming: a promising frontier for orphan drug production.Biotechnology letters · 2025Review
- Expression of endochitinase and exochitinase in lettuce chloroplasts increases plant biomass and kills fungal pathogen Candida albicans.Plant biotechnology journal · 2025Article
- Clinical studies in Myxomatous Mitral Valve Disease dogs: most prescribed ACEI inhibits ACE2 enzyme activity and ARB increases AngII pool in plasma.Hypertension research : official journal of the Japanese Society of Hypertension · 2025Article
- Debulking influenza and herpes simplex virus strains by a wide-spectrum anti-viral protein formulated in clinical grade chewing gum.Molecular therapy : the journal of the American Society of Gene Therapy · 2025Article
- Evaluation of Biologics ACE2/Ang(1-7) Encapsulated in Plant Cells for FDA Approval: Safety and Toxicology Studies.Pharmaceutics · 2024Article
- Factor IX administration in the skin primes inhibitor formation and sensitizes hemophilia B mice to systemic factor IX administration.Research and practice in thrombosis and haemostasis · 2023Article
- Delivery of biologics: Topical administration.Biomaterials · 2023Review
- Plant cell-based drug delivery enhances affordability of biologics.Nature biotechnology · 2023Article
- Affordable oral proinsulin bioencapsulated in plant cells regulates blood sugar levels similar to natural insulin.Biomaterials · 2023Article
- Abatement of microfibre pollution and detoxification of textile dye - Indigo by engineered plant enzymes.Plant biotechnology journal · 2023Article
- Distinct functions and transcriptional signatures in orally induced regulatory T cell populations.Frontiers in immunology · 2023Article
- Oral tolerance to prevent anti-drug antibody formation in protein replacement therapies.Cellular immunology · 2022Review
- Plants as Sources of Natural and Recombinant Antimalaria Agents.Molecular biotechnology · 2022Review
- Article
- Debulking SARS-CoV-2 in saliva using angiotensin converting enzyme 2 in chewing gum to decrease oral virus transmission and infection.Molecular therapy : the journal of the American Society of Gene Therapy · 2022Article
- Development of an efficient marker-free soybean transformation method using the novel bacterium Ochrobactrum haywardense H1.Plant biotechnology journal · 2022Article
- Article
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Authors and funding
7 authors at 3 institutions in 1 country.
Funding
Abstract
Anti-drug antibody (ADA) formation is a major complication in treatment of the X-linked bleeding disorder haemophilia B (deficiency in coagulation factor IX, FIX). Current clinical immune tolerance protocols are often not effective due to complications such as anaphylactic reactions against FIX. Plant-based oral tolerance induction may address this problem, as illustrated by the recent first regulatory approval of orally delivered plant cells to treat peanut allergy. Our previous studies showed that oral delivery of plant cells expressing FIX fused to the transmucosal carrier CTB (cholera toxin subunit B) in chloroplasts suppressed ADA in animals with haemophilia B. We report here creation of the first lettuce transplastomic lines expressing a coagulation factor, in the absence of antibiotic resistance gene. Stable integration of the CTB-FIX gene and homoplasmy (transformation of ˜10 000 copies in each cell) were maintained in both T1 and T2 generation marker-free plants. CTB-FIX expression in lyophilized leaves of T1 and T2 marker-free plants was 1.0-1.5 mg/g dry weight, confirming that the marker excision did not affect antigen levels. Oral administration of CTB-FIX to Sprague Dawley rats at 0.25, 1 or 2.5 mg/kg did not produce overt adverse effects or toxicity. The no-observed-adverse-effect level (NOAEL) is at least 2.5 mg/kg for a single oral administration in rats. Oral administration of CTB-FIX at 0.3 or 1.47 mg/kg either mixed in food or as an oral suspension to Beagle dogs did not produce any observable toxicity. These toxicology studies should facilitate filing of regulatory approval documents and evaluation in haemophilia B patients.
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Registered trials
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