Lysogene selects Brammer Bio to produce GM1 Gangliosidosis gene therapy product.
Lysogene has entered into a strategic manufacturing agreement with Brammer Bio, a best-in-class viral gene and cell therapy manufacturer.
Brammer Bio will produce LYS-GM101, an AAVrh10-based gene therapy, for clinical testing of the therapeutic candidate in patients with GM1 Gangliosidosis, a rare neuronopathic lysosomal storage disorder.
“We are pleased to have secured Brammer Bio, a leading manufacturer with proven expertise in the development of robust industrial-scale manufacturing of AAV-based products, to provide the highest quality LYS-GM101 product for clinical testing,” said Mark Plavsic, Chief Technical Officer at Lysogene. “This agreement ensures Lysogene has established commercial-ready gene therapy manufacturing in line with our need for the product”.
Pre-clinical data in animal models of GM1 show that LYS-GM101 treatment delivers a functional gene encoding the βgal enzyme resulting in a reduction of GM1 gangliosides and transforms the animal phenotype. These studies will support an Investigational New Drug application and the launch of the Phase I clinical trial, expected to launch in 2019.
“We are delighted to partner with Lysogene to manufacture this commercial-ready AAVrh10 gene therapy product,” stated, Mark Bamforth, President and CEO of Brammer Bio. “We embrace this opportunity to help patients in need and re-affirm Brammer Bio’s leadership position as the manufacturer of choice in the gene therapy space.”
Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!
Filed Under: Drug Discovery