CEVEC Pharmaceuticals GmbH (CEVEC), the expert in the production of tailor-made recombinant glycoproteins and gene therapy vectors, and global biotechnology leader CSL Limited announced an exclusive licensing agreement for the development, manufacture and commercialisation of recombinant C1 Esterase Inhibitor (C1-INH) proteins for Hereditary Angioedema (HAE) and other potential indications using CEVEC's proprietary CAP Go technology.

Under the terms of the agreement, CEVEC grants an exclusive license for the development, manufacture and commercialisation of CAP Go-derived C1-INH proteins to CSL. In addition, CEVEC will provide its expertise in the development and use of CAP Go cell lines expressing C1-INH, and in optimising the expression of highly glycosylated and difficult to produce proteins. The licensing agreement was the result of an ongoing collaboration between CSL and CEVEC, which yielded initial data on the significant potential of the CAP Go technology to enable the development of a differentiated recombinant C1-INH product candidate. Financial details of the agreement have not been disclosed.

Under the agreement, CSL aims to develop CAP Go-derived C1-INH proteins with tailored glycosylation, leading to an improved half-life and more convenient application. CEVEC's proprietary CAP-technology may allow for the industrial manufacture of such a protein given the scalable production process established for CAP Go cells.

"The agreement with CSL is a further endorsement of our unique human expression system with the intention to take our CAP Go technology to the next level of implementation for the production of difficult to express recombinant proteins," said Dr. Nico Scheer, chief business officer of CEVEC Pharmaceuticals GmbH. "Its outstanding characteristics in terms of authentic and tailor-made glycosylation capabilities, high yield production of complex proteins and scalability, combined with its IP protection and the complete documentation of the CAP cells make the CAP Go technology the ideal choice for industrial scale production of glyco-optimised proteins. We are looking forward to supporting CSL with this exciting project."

"At CSL, we are patient focused and we are driven by our promise to patients. CEVEC's CAP Go technology provides us with the opportunity to develop an innovative and differentiated recombinant and glyco-optimised C1-INH protein for HAE and potential other indications. The potential increase in convenience and quality of life for patients will help us further expand our position in this very important market," Dr. Andrew Nash, senior vice president research, CSL, added.

HAE is a rare and potentially life-threatening genetic condition that occurs in about 1 in 10,000 to 1 in 50,000 people. HAE is caused by deficient or dysfunctional C1-INH, a protein in the blood that helps to control inflammation. Inadequate amounts of properly functioning C1-INH can lead to the accumulation of fluid in body tissues, causing considerable swelling referred to as angioedema. HAE attacks can affect many parts of the body and can spread to multiple sites, including the face, abdomen, larynx, and extremities. Patients who have abdominal attacks of HAE can experience extreme pain, diarrhoea, nausea, and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face or throat can result in airway closure, asphyxiation, and, if left untreated, death.

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza.