The strategic agreement to manufacture relates to the product of gene therapy of Lysogene, which uses the vector AAVrh10
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PARIS, France and CAMBRIDGE, Mass., USA – may 24, 2017 – Lysogene, (the “Company” FR0013233475 – LYS) is a biopharmaceutical company specializing in gene therapy targeting diseases of the central nervous system (CNS), today announced the signing of a strategic agreement to manufacture with Brammer Bio, one of the leading manufacturers of cell therapy products and gene by viral vector.
Brammer Bio will manufacture LYS-GM101, the second drug candidate of Lysogene using the vector AAVrh10, for clinical trials in the indication of Gangliosidosis GM1, neuropathy rare, characterized by a lysosomal storage, which results in the premature death of the patients.
“We are very pleased to have signed this agreement with Brammer Bio, one of the main actors with competence demonstrated in the industrial-scale manufacture of products based on the technology of AAV, to provide the best quality product for the clinical trials of LYS-GM101,” said Mark Plavsic, Chief Technical officer of Lysogene. “This agreement ensures that we include a supply of drugs for gene therapy in marketable condition by the following and in accordance with the needs that we have. ”
Preclinical data from animal models have shown that the LYS-GM101 reduced substrates toxic (gangliosides to GM1) and transforms the phenotype of the animal, by introducing a functional copy of the gene coding for the missing enzyme (ß-galactosidase). These studies support also the request of the status of” Investigational New Drug ” and the launch of the Phase I clinical trial, which is expected to occur in 2019.
“We are delighted to partner with Lysogene for the manufacture of the product of gene therapy for their future studies and then to the commercialization phase where the same process will be used,” said Mark Bamforth, President and ceo of Brammer Bio. “We are very happy for this opportunity that is given to us to help patients in need, and to reaffirm the status of the leader of Brammer Bio manufacturing in the choice of drugs for gene therapy. ”
About GM1
Gangliosidosis GM1 is a rare neurodegenerative disorder characterized by delays in cognitive and motor development severe leading to early death. The disease is caused by mutations in the gene GLB1, which encodes beta-galactosidase, an enzyme necessary for the recycling of the molecule GM1-gangliosidosis in neurons. This lipid of the brain is essential for normal operation, but its accumulation leads to a neurodégénerescence and severe neurological symptoms. To the knowledge of the Company, there is to date no treatment to stabilize or slow down the clinical status of patients with GM1.
About Brammer Bio
Brammer Bio provides the large laboratories of pharmaceutical and biotechnology companies, the vectors of gene therapy in vivo and cell-based ex vivo to meet their needs clinical and commercial, as well as development services on a formal and analytical, and support in contacts with the authorities in charge of regulations, to accelerate the placing on the market of innovative medicines that improve patient health. Brammer Bio is owned by Ampersand Capital Partners, the sole institutional investor in this capital, and by its founders. For more information, visit the website www.brammerbio.com
About Lysogene
Lysogene is a biotechnology corporation clinical stage pioneer in the basic research and the clinical development of gene therapies using vectors derived from adeno-associated viruses to treat rare diseases and life-threatening CNS of the child, for which there is today, to the knowledge of the Company, no treatment. Since 2009, Lysogene has put in place a strong platform and a large network, with innovative products in the MPS-IIIA and in the gangliosidosis GM1. Each of the products developed by Lysogene, LYS-SAF302 and LYS-GM101, has orphan drug designations by the FDA and the EMA, and the designation of rare disease pediatric by the FDA.
Lysogene is listed on the regulated market of Euronext Paris of Euronext Paris (ISIN code : FR0013233475). More information : www.lysogene.com.
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