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.”
Filed Under: Drug Discovery