Lysogene collaborates with Brammer Bio to produce LYS-GM101

Lysogene and Brammer Bio has entered into manufacturing agreement. Brammer Bio will produce an AAVrh10-based gene therapy, LYS-GM101 for clinical testing of the therapeutic candidate in patients with GM1 Gangliosidosis.

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.

Lysogene Chief Technical Officer, Mark Plavsic said that they 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. This agreement ensures Lysogene has established commercial-ready gene therapy manufacturing in line with our need for the product.

Brammer Bio President and CEO, Mark Bamforth said that they are delighted to partner with Lysogene to manufacture this commercial-ready AAVrh10 gene therapy product. They 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.