Lysogene

Lysogene Enters into a Loan Agreement of €15 million with the European Investment Bank (EIB)

Retrieved on: 
Friday, December 24, 2021
Biotechnology, Genetics, Health, Kepler, Sarepta Therapeutics, European Investment Bank, Fragile, Sale, Autism, Lists of diseases, MPS, Exercise, CNS, European Agricultural Guarantee Fund, Financial Services and Markets Authority (Belgium), Investment, BPI, Achievement, Forward-looking statement, COVID-19, Central nervous system, Fragile X syndrome, EIB, Union, History, Climate, Company, LYS, Therapy, Research, Adaptive clinical trial, GM1, Clinical trial, Parity, Vaccine, Partnership, Pharmaceutical industry, EU, GM1 gangliosidoses, the European Investment Bank (EIB), Lysogene, THE EUROPEAN INVESTMENT BANK (EIB), LYSOGENE

Lysogene (FR0013233475 LYS), a phase 3 gene therapy platform Company targeting central nervous system (CNS) diseases, announced today that it has entered into a 15 million loan agreement with the European Investment Bank to accelerate the development of its gene therapy platform.

Key Points: 
  • Lysogene (FR0013233475 LYS), a phase 3 gene therapy platform Company targeting central nervous system (CNS) diseases, announced today that it has entered into a 15 million loan agreement with the European Investment Bank to accelerate the development of its gene therapy platform.
  • Lysogene will receive the EIB loan in three tranches including a first tranche of 3 million that can be unconditionally drawn down and two other tranches of respectively 5 million and 7 million available upon completion of pre-defined milestones.
  • With the 4.3 million BPI non-dilutive announced in November, this brings total funding agreements to nearly 20 million.
  • The loan is supplemented by an agreement to issue warrants to the EIB, whose number varies according to the tranche and Lysogenes share price.

Lysogene Receives MHRA and Research Ethics Committee Approvals to Initiate the Gene Therapy Clinical Trial in the UK with LYS-GM101 for the Treatment of GM1 Gangliosidosis

Retrieved on: 
Monday, January 11, 2021
Health, Hospitals, Genetics, Clinical trials, Pharmaceutical, Biotechnology, Branches of biology, Biology, Life sciences, Gene delivery, Medical genetics, Genetic engineering, Applied genetics, Emerging technologies, Gene therapy, Viral vector, Oncolytic AAV, Adeno-associated virus, Lysogene, Manchester University NHS Foundation Trust

LYS-GM101 builds on Lysogenes extensive experience in direct to CNS adeno-associated viral vector (AAV)-based gene therapy clinical development.

Key Points: 
  • LYS-GM101 builds on Lysogenes extensive experience in direct to CNS adeno-associated viral vector (AAV)-based gene therapy clinical development.
  • This trial builds on Lysogenes considerable expertise for AAV gene therapy and clinical development.
  • Lysogene is a gene therapy Company focused on the treatment of orphan diseases of the central nervous system (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.

Lysogene Receives FDA Fast Track Designation for LYS-SAF302 Gene Therapy in MPS IIIA

Retrieved on: 
Tuesday, February 25, 2020
Health, FDA, Genetics, Other Health, Clinical trials, Pharmaceutical, Biotechnology, Branches of biology, Biology, Life sciences, Food and Drug Administration, Emerging technologies, Gene delivery, Medical genetics, Molecular biology, Gene therapy, Fast track, Priority review, MPS IIIA, LYS-SAF302, Lysogene

Lysogene (Paris:LYS) (FR0013233475 LYS), a pioneering Phase 3 gene therapy platform company targeting central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its LYS-SAF302 program for the treatment of mucopolysaccharidosis Type IIIA (MPS IIIA).

Key Points: 
  • Lysogene (Paris:LYS) (FR0013233475 LYS), a pioneering Phase 3 gene therapy platform company targeting central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its LYS-SAF302 program for the treatment of mucopolysaccharidosis Type IIIA (MPS IIIA).
  • A product that receives Fast Track designation is eligible for more frequent interactions with FDA, potential eligibility for accelerated approval, priority review, and rolling Biologics License Application (BLA) review.
  • This Fast Track designation demonstrates the regulators sustained interest in Lysogenes cutting edge in vivo gene therapy program.
  • LYS-SAF302 is an AAV-mediated gene therapy, the goal of which is to replace the faulty SGSH gene with a healthy copy of the gene.