NOVASEP and LYSOGENE Announce their New Collaboration for Development and Production of GM1 Gangliosidosis Gene Therapy Product

This agreement covers the manufacturing of the Adeno-Associated Virus (AAV)

LYON, France & PARIS--(BUSINESS WIRE)--Regulatory News:

Novasep, a leading supplier of services and technologies for the life sciences industry, and Lysogene (Paris:LYS)(FR0013233475 – LYS), a phase 3 gene therapy platform company targeting central nervous system (CNS) diseases, today announced the signature of an agreement for the development and manufacturing of LYS-GM101, an AAVrh10-based gene therapy drug candidate for the treatment of GM1 Gangliosidosis, a rare neuronopathic lysosomal storage disorder.

With this collaboration, the two companies consolidate their long-lasting partnership initiated with the development and manufacturing of Lysogene’s lead gene therapy product, LYS-SAF302, currently in clinical phase 2/3.

Mark Plavsic, Lysogene’s Chief Technical Officer said: “Following the successful relationship developed during the past 4 years, I am very pleased to continue working with Novasep, which is emerging as a true leader in gene therapy development and manufacturing. By extending our collaboration, we secure the clinical production of our experimental treatment for GM1 gangliosidosis and take an option for a smooth and effective technical transfer to a future commercial process.”

Cedric Volanti, Novasep’s President of Biopharma Solutions said: "We, at Novasep, are delighted to pursue and extend our partnership with Lysogene. Novasep will bring its expertise and mobilize its production capacities to first help Lysogene in the clinical development of its innovative gene therapy treatment for GM1 gangliosidosis; and secondly, to shorten the transition to a commercial product manufacturing by ensuring a smooth process transfer to our commercial manufacturing facility."

About Lysogene

Lysogene is a gene therapy company focused on the treatment of orphan diseases of the central nervous system (CNS). The company has built a unique capability to enable a safe and effective delivery of gene therapies to the CNS to treat lysosomal diseases and other genetic disorders of the CNS. A phase 2/3 clinical trial in MPS IIIA in partnership with Sarepta Therapeutics, Inc. is ongoing and a phase 1/3 clinical trial in GM1 gangliosidosis is in preparation. In accordance with the agreements signed between Lysogene and Sarepta Therapeutics, Inc., Sarepta Therapeutics, Inc. will hold exclusive commercial rights to LYS-SAF302 in the United States and markets outside Europe; and Lysogene will maintain commercial exclusivity of LYS-SAF302 in Europe. Lysogene is also collaborating with an academic partner to define the strategy of development for the treatment of Fragile X syndrome, a genetic disease related to autism. www.lysogene.com.

About Novasep

Novasep provides cost-effective and sustainable manufacturing solutions for the life sciences industries.

With 20 years’ experience in the development and manufacturing of biomolecules, Novasep offers a full range of CDMO services for:

- Viral vectors (AAV, Adenovirus, Lentivirus, HSV, VSV, VEEV…) for cell and gene therapy, immunotherapy and vaccination, from process development to cGMP production

- Fill & Finish services for viral vectors, attenuated and live viruses, mAbs, plasmids and other biologics, from formulation to packaging

As part of its growth strategy Rise-2, Novasep recently unveiled a new facility, Senrise-IV, dedicated to the commercial production of viral vectors which has been completed last year by Senefill, a new Fill & Finish commercial facility for aseptic operations. Both facilities located in Seneffe, Belgium, will contribute to the success of biopharmaceuticals’ projects.