AzarGen Biotechnologies Granted European Patent for Plant-Made Production of Recombinant Human Surfactant Protein-B

PRNewswire: July 25, 2017 – STELLENBOSCH, South Africa – AzarGen Biotechnologies (Pty) Ltd. (Stellenbosch, South Africa) announced that it has received grant status for the patent application Production of Human Pulmonary Surfactant Protein-B in Plants (EP3013963) from the European Patent Office.

Exogenous pulmonary surfactant is routinely being used in surfactant replacement therapy applications to treat neonatal respiratory distress syndrome (nRDS). Animal-derived surfactant contains very low amounts of surfactant protein-B (SP-B), one of the key proteins that, combined with phospholipids, are essential to lower surface tension and increase lung compliance during breathing.

“With the focus on developing a new surfactant preparation, we believe that by combining a high concentration of functional recombinant human SP-B and analogs thereof with a synthetic lipid mixture we may significantly improve pulmonary surfactant dynamics with potential use in various inhalation drug delivery platforms,” said Dr. Cobus Zwiegelaar, COO of AzarGen. “Using proprietary technology by iBio, Inc. (NYSE MKT: IBIO), a leader in developing plant-based biopharmaceuticals, the plant-made production platform offers new hope to produce recombinant human SP-B proteins in sufficient amounts and purity, at a significantly lower cost.”

The biological complexity of native human SP-B structure presents a major obstacle to obtain significant amounts of active/functional SP-B and different methodologies ranging from the extraction from animal (bovine or porcine) minced lungs to solid-phase synthetic peptide synthesis may be expensive and labor intensive.

“We are optimistic about the commercial and public health benefits of combining the inventive work of AzarGen with iBio’s proprietary technologies and capabilities,” said Robert Erwin, president of iBio. “We are committed to working closely with AzarGen to reduce the time usually required with traditional technologies to move product development and testing from one stage to the next, for both good business reasons and to provide the best possible outcome for patients.”

AzarGen aims to develop novel synthetic pulmonary surfactant formulations comprising functional recombinant human SP-B and/or analogs thereof. This could extend the application of an exogenous surfactant, used alone for surfactant replacement therapy or in combination with other therapeutics, to treat a wider range of respiratory conditions.”

iBio, a leader in developing plant-based biopharmaceuticals, provides a range of product and process development, analytical, and manufacturing services at the large-scale development and manufacturing facility of its subsidiary iBio CMO LLC in Bryan, Texas. The facility houses laboratory and pilot-scale operations, as well as large-scale automated hydroponic systems capable of growing over four million plants as “in process inventory” and delivering over 300 kilograms of therapeutic protein pharmaceutical active ingredient per year. Facility capacity can be doubled by adding additional plant growth equipment in a space already reserved for that purpose.

iBio applies its technology for the benefit of its clients and the advancement of its own product interests. The company’s pipeline is comprised of proprietary candidates for the treatment of a range of fibrotic diseases including idiopathic pulmonary fibrosis, systemic sclerosis, and scleroderma. IBIO-CFB03, based on the company’s proprietary gene expression technology, is the company’s lead therapeutic candidate being advanced for IND development. Further information is available at www.ibioinc.com.

AzarGen is a biotechnology company focused on developing human therapeutic proteins using advanced genetic engineering and synthetic biology techniques in plants. The company’s lead therapeutic candidate is a recombinant human surfactant protein (based on rh-SPB) targeted for various respiratory disease conditions. AzarGen has developed proprietary synthetic DNA promoters for various expression platform applications in plant-made pharmaceuticals, synthetic biology, and GMO-crop improvement.

The AzarGen management team is supported by an experienced advisory board for strategic guidance and intellectual property management. Based in Stellenbosch, South Africa, AzarGen has made great progress to move a portfolio of proprietary biopharmaceutical products forward with support from South Africa’s Industrial Development Corporation (IDC).