Albumin Fusion and Next Generation Fusion Technologies

CoGenesys’ albumin fusion technology provides a unique opportunity to develop improved versions of proteins, peptides, or enzyme therapeutics, by modifying the molecules of interest with a stable fusion partner to generate long-acting products. The genetic fusion results in expression of a single recombinant polypeptide. CoGenesys has established the infrastructure and know-how necessary to produce fusion proteins at clinical scale in both microbial and mammalian expression systems. The clinically validated albumin fusion technology benefits from an efficient, scalable and adaptable manufacturing platform for cGMP production and is well suited for rapid development. CoGenesys is interested in seeking collaborations with companies to improve proprietary proteins, peptides or enzymes that would benefit from combination with the albumin fusion technology. In addition to the albumin fusion technology, CoGenesys is developing next generation fusion technologies that employ new fusion partners and expression systems that can be tailored to the structural and expression constraints that may be associated with individual proteins, peptides and enzymes.

Extended Duration Albumin Fusion Product Opportunities

Albutropin

Albutropin™ is a protein derived from a direct fusion of the gene for human growth hormone (hGH) gene and the gene for human serum albumin. This fusion produces a single polypeptide molecule that combines physiological properties of hGH with the long half-life of serum albumin. Albutropin™ is being developed to address the unmet need in growth hormone deficiency (GHD) for an agent that offers a convenient administration schedule while preserving safety and efficacy of the short-acting preparations. The potential convenience benefits derive from the improvements in growth hormone pharmacokinetics conferred by its albumin component. A forty two patient Phase 1 clinical study has been completed in adult GHD patients. The data from the Phase 1 trial indicates that Albutropin™ could be developed for once-weekly subcutaneous administration.

Albupoietin

Albupoietin™ is a protein derived from a direct fusion of the gene for human erythropoietin (EPO) and the gene for human serum albumin. The fusion produces a single polypeptide that combines the therapeutic activity of erythropoietin (EPO) with the long half-life characteristics of human serum albumin. Albupoietin™ has demonstrated activity in numerous in vitro and in vivo models with data suggesting an enhanced PK/PD profile relative to other long acting EPO products presently on the market. A completed investigational new drug package is available for Albupoietin.

Albuferon Beta

Albuferon Beta is a protein derived from a direct fusion of the gene for human interferon-beta (IFN-beta) and the gene for human serum albumin. The fusion produces a single polypeptide that combines the therapeutic activity of interferon-beta (IFN-beta) with the long half-life characteristics of human serum albumin. Albuferon Beta has demonstrated activity in numerous in vitro and in vivo models with data suggesting a competitive PK/PD profile relative to other long acting interferon-beta products presently on the market. A completed investigational new drug package is available for Albuferon Beta.