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Technology Validation

The Albumin fusion platform is a clinically validated technology with a proven track record for enabling rapid development of biopharmaceutical products that demonstrate safety, efficacy and clear market value. CoGenesys can use this HSA-fusion technology to improve both clinically validated and other well-characterized bioactive proteins and peptides with the goal of rapid clinical evaluation. Currently, there are more than 40 marketed peptides worldwide, approximately 270 peptides in clinical testing, and about 400 in advanced preclinical phases.

Albumin fusion technology also exhibits a powerful demonstration of prolonging the half-life of small bioactive peptides. In general, peptide drugs have to be administered to patients frequently (or by continuous infusion) due to their rapid clearance from circulation. Many bioactive peptides long known for their potential beneficial pharmacologic action have not been further developed due to their very short serum half-life. HSA-fusion technology has been used successfully to produce long-acting versions of numerous peptides including GLP-1, GLP-2, BNP, PTH and others.

Long-acting peptide agonists of blockbuster drugs such as erythropoietin and GCSF are also attractive opportunities. CoGenesys is currently considering a variety of HSA-fusion peptides and proteins for a number of disease indications, including but not limited to the following: cancer, cardiovascular diseases, metabolic diseases, infectious diseases, autoimmune diseases, CNS diseases.

Albumin fusion products:

• The most advanced albumin fusion product, Albuferon^TM, completed large phase 2 trials, where it demonstrated strong proof of efficacy and safety compared with Pegasys (pegylated interferon); this product is currently in pivotal Phase 3 trials and is being developed in a partnership between Human Genome Sciences and Novartis.

• A second albumin fusion product, Syncria^TM (formerly GSK716155 and Albugon), is being developed by GlaxoSmithKline. Syncria^TM is an albumin fusion protein based on the anti-diabetic peptide GLP-1 and is currently in Phase 2b trials in type 2 diabetes.

• Albumin fusion technology has also been used to produce long-acting versions of human growth hormone (Albutropin^TM), B-type naturietic peptide (Cardeva^TM) G-CSF (Neugranin^TM), erythropoietin (Albupoietin^TM), insulin (Albulin-G^TM), IGF-1, and interferon-beta. Each of these proteins has shown promising activity profiles in preclinical and/or clinical testing and an extended half life.