Polyplus-transfection has announced that it has obtained a EUR 80,000 grant from AFM (Association Française contre les Myopathies), France's Muscular Dystrophy Association.
The grant will finance the cGMP (current good manufacturing practices) compliant production process of its in vivo-jetPEI™ reagent, thus enabling its use in gene therapy.
Polyplus-transfection believes this upgrade to the cGMP production process will accelerate the use of in vivo-jetPEI™ in gene therapy clinical trials in humans. The funding also covers the development of new quality control procedures as well as stability studies.
In vivo-jetPEI™ is a synthetic molecule, polyethylenimine (PEI). PEI is a cationic linear polymer recognized as being the most effective reagent on the market for in vivo delivery of nucleic acids. With in vivo-jetPEI™, Polyplus-transfection offers clinicians an alternative technology for gene therapy to the commonly used viral approach using deactivated viruses.
In vivo-jetPEI™ is easy to use and does not trigger an immune response, a huge advantage compared to viruses which are very immunogenic and do not allow repeated use.
"Today Polyplus-transfection offers the only solution on the market to deliver genetic material using a synthetic molecule instead of a virus," said Joelle Bloch, CEO of Polyplus-transfection.
"With the help of the AFM funding for the development of a cGMP production process, in vivo-jetPEI™ will be available to customers for use in clinical trials. This new gene/drug delivery tool represents a new hope for patients.
"At Polyplus-transfection we believe that this new process will accelerate our growth as well as demonstrate our expertise in the field of gene delivery, offering a serious alterative to viral approaches and emphasizing the strength of our reagents for in vivo assays," Mr. Bloch continued.