iBio, Inc. has entered into the initial Statement of Work (SOW1) under its Memorandum of Understanding (MOU) with AzarGen Biotechnologies.

Following the successful use of iBio’s technologies and manufacturing capabilities to advance the development of AzarGen’s surfactant protein therapeutic through an initial assessment of production feasibility, 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.

Pursuant to the SOW1, iBio will manufacture research quantities of a plant-made rituximab for AzarGen using its 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. “We look forward to helping AzarGen develop a plant-based, bio-similar 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. “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 by the U.S. FDA in 1997 for treatment of 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 was one of the world’s top-10 selling pharmaceuticals in 2018.