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Genetic Polymer™ Technology Extends Half-Life of Protein Pharmaceuticals

In the first half of 2007, we formed a spin-off company, Aequus BioPharma, Inc., to further develop a technology created by CTI scientists to extend the plasma half life of recombinant DNA (rDNA) derived protein pharmaceuticals by genetically ligating an amino acid polymer domain to a biologically active protein sequence resulting in a novel, unique and patentable gene.

Our studies suggest that this Genetic Polymer™ technology may simplify the manufacture of current protein pharmaceuticals that use chemical conjugation technology to extended plasma half-life, including follow-on biologics, or biosimilars, thus lowering their cost.

Strategy for Application of Genetic Polymer™ Technology to the Development of Follow-On Biologics

In addition to its potential for producing lower cost follow-on biologics, we believe this recombinant DNA technology might be used to develop novel biologics, in a wide array of malignant, inflammatory, or infectious diseases. The Genetic Polymer™ technology is a platform that should be applicable to many different protein pharmaceuticals. This, in turn, may eliminate the need to develop individualized technology for extending the plasma half-life of each protein pharmaceutical, allowing for more convenient dosing.

Our data also suggest that biosynthesis in traditional mammalian cell protein expression systems will allow for the production of a protein pharmaceutical with prolonged plasma half-life, but without the requirement for further chemical modifications subsequent to protein expression.

It is our opinion that this proprietary Genetic Polymer™ technology creates novel compositions of matter, allowing for the commercialization of protein pharmaceuticals without infringing on the patents of other companies with competing technologies.

We have preliminary proof of principle data demonstrating utility of the Genetic Polymer™ technology, and Aequus BioPharma’s mission will be to generate additional experimental data to further validate this initial product and the technology platform.

The first protein pharmaceutical the company plans to move into preclinical and chemical development studies is a novel, long-acting G-CSF biosimilar.

About Follow-On Biologics and Biosimilars

Biologics, especially recombinant DNA (rDNA) derived protein pharmaceuticals, represent the fastest growing segment of pharmaceutical sales, currently at $51 billion worldwide and expected to hit $87 billion by 2010. Industrial scale protein production technologies are currently being applied to the development of a wide variety of protein-based therapeutics, including hormones, growth factors, antibodies and cytokine modulators, to treat a vast range of human diseases.

Frequently, these drugs have a relatively short plasma half-life. As a result, several physical, genetic, and chemical approaches have been developed to extend the plasma half-life of the therapeutic proteins while not compromising efficacy or introducing safety issues (immunogenicity and other off-mechanism toxicities).

The most successful of these approaches has been chemical conjugation with monomethoxypolyethylene glycol (PEG), amino acid engineering leading to altered protein glycosylation and the addition of non-biologically active "carrier" domains.

Benefit Patients Sooner: Congress should create follow-on biologics pathway ASAP (66k PDF)
A statement by James A. Bianco, MD, CTI President & CEO

For more information, contact Dan Eramian, Executive Vice President Corporate Communications, 206-282-7100.