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The companies have advanced their collaboration to the next stage and will continue to develop a plant-based biosimilar candidate to Roche’s Rituxan.
iBio, a plant-based biopharmaceutical contract development and manufacturing organization (CDMO), announced on Sept. 17, 2019 that it has entered into an initial statement of work (SOW1) under its memorandum of understanding (MOU) with AzarGen Biotechnologies, a biotechnology company specializing in advanced genetic engineering and synthetic biology techniques in plants to develop therapeutics.
iBio had successfully advanced the development of AzarGen’s surfactant protein therapeutic through an initial assessment of production feasibility. Then in May 2017, the two companies expanded their collaboration by initiating the development of a plant-made rituximab for the South African market under the MOU. Rituximab is the active ingredient in Rituxan/MabThera, one of Roche’s top-selling drugs with approximately CHF 5.2 billion (US$5.3 billion) in 2018 sales.
Pursuant to the SOW1, iBio will manufacture research quantities of a plant-made rituximab for AzarGen using iBio’s proprietary FastPharming system. Following batch production, the drug product candidate will undergo testing via iBio CDMO’s bioanalytical services.
“After demonstrating the success of our platform through our opening project with AzarGen, we are now advancing to the next stage of the two companies’ collaboration,” commented Robert B. Kay, iBio’s chairman and CEO, in a company press release. “We look forward to helping AzarGen develop a plant-based, biosimilar rituximab product for the South African market.”
“The early success in combining iBio’s and AzarGen's advanced genetic engineering and synthetic biology techniques in plants really empowered us to evolve our business plans and product priorities to initiate development of a biosimilar version of rituximab,” said Dr. Mauritz Venter, CEO of AzarGen, in a company press release. “As we continue to move toward the initiation of advanced pre-clinical activities, we are confident that iBio CDMO is ideally suited to provide us with the requisite long-term process development and cGMP manufacturing support. We are excited to take this important step forward in advancing this program. Focusing on accessibility and affordability of biological medicine for the African continent, we look forward to initiating additional projects with iBio as we progress.”
Rituximab was first approved in the United States by FDA in 1997 under the Rituxan brand name for treating certain B cell non-Hodgkin lymphomas. Since that time, its clinical uses have expanded to encompass treatment of chronic lymphocytic leukemia, as well as a range of autoimmune diseases, including certain types of rheumatoid arthritis. Rituximab has been placed on the World Health Organization’s List of Essential Medicines and was ranked as one of the world’s top-10 selling pharmaceuticals in 2018, iBio cited.