Cell Therapeutics plans to form a spin-off company, Aequus BioPharma, to further develop its Genetic Polymer™ technology that it predicts will speed the manufacture, development, and commercialization of biopharmaceuticals, including follow-on biologics or so-called biosimilars.
“A key pitfall of protein therapeutics has been the relatively short plasma life of these types of drugs, which leads to the need for frequent injections and higher associated costs for therapies,” points out CTI’s president and CEO, James A. Bianco, M.D. “Aequus BioPharma will utilize the Genetic Polymer technology, discovered at CTI, which we expect to extend the plasma half-life of therapeutic proteins and provide a potentially less expensive, streamlined development pathway for next-generation biologics like Neulasta or Aranesp,” adds Dr. Bianco.
“In addition to its application in producing lower cost follow-on biologics, we believe this recombinant technology might be utilized to develop novel biologics and also deliver small inhibitors of RNA to their cellular targets in a wide array of malignant, inflammatory, or infectious diseases.”
The Genetic Polymer technology can be used with multiple molecules, which may eliminate the need to develop individualized technology for extending the plasma half-life of each biopharmaceutical, explains Dr. Bianco. The technology itself is a recombinant DNA process that ligates a secretion sequence with a biologically active protein sequence and a poly-amino acid sequence resulting in a novel, unique and patentable gene, according to CTI.
The company believes that expression in traditional mammalian cell systems will allow for the production of a biologic protein with prolonged plasma half-life but without the requirement for further chemical modifications subsequent to protein expression, thus potentially speeding the manufacturing process and lowering the cost of goods.