Screen Shot 2018 05 28 at 7.57.20 AMAzarGen is an early stage company in South Africa that is developing a portfolio of products for global and African markets. AzarGen is developing a biosimilar Rituximab targeted for non-Hodgkins lymphoma in South Africa. Monoclonal antibody therapies are largely unavailable in South Africa. Less than 3% of the population has access to these therapies, primarily due to the cost of importing the appropriate drugs. A recent symposium sponsored by iBio and the University of Cape Town focused on the need for biologics in South Africa and the African continent in general. Large technical funding bodies were represented as well as academic institutions, and privately held companies. The symposium participants agreed that the capital costs of a CHO based facility and the COGS of a rituximab or Herceptin®-type product were prohibitively expensive and that the PMP solution was the best way forward. The Department of Science and Technology pledged to start a feasibility project to build a PMP pilot production facility in South Africa. The members of the symposium also agreed that products should be brought forward in the PMP production system and made by companies like iBio with the eventual plan to transfer the products and technology to South Africa in the future. There are at least 5 government funded laboratories developing biotherapeutics in plant made expression systems. 

AzarGen is moving forward with a “biosimilar” Rituxan-like product that iBio has developed in plants. The product shows equivalent ADCC and binding as the “founder” product made in CHO.  The product is produced at high expression levels in the iBio system. AzarGen has made use of all of the tools in the iBio system as described above including: 1. Rapid “down-select” of several candidates, 2. Rapid process development, and 3. Early stage risk assessment and developing a regulatory path. The company is now ready to produce materials for pre-clinical animal testing and preparing a Pre-IND package for FDA. 

In this case the plant-made system provides the only economically suitable platform for eventual production of mAb based biologics in South Africa.