India Pharma Outlook Team | Monday, 08 January 2024
Sensorion announces that the research partnership framework agreement signed in 2019 with the Institut Pasteur (Paris, France), which granted Sensorion an option for exclusive licenses to develop and market gene therapy drug candidates derived from collaborative projects to address unmet medical needs in the hearing field, has been extended for five years. The agreement has been revised to extend it until December 31, 2028, in order to encourage further development of gene therapy projects.
SENS-501, the most advanced program within the partnership that targets deafness caused by mutations in the gene coding for otoferlin, defined as a priority in 2019, has met its objectives. The successful completion of the efficacy preclinical package in the frame of the collaboration between Sensorion and the Institut Pasteur advanced the program with the development of the OTOF-GT product (SENS-501) towards clinical stage, as per pharmabiz.
A Clinical Trial Application (Audiogene, phase 1/2 clinical study) was submitted in July 2023 in the UK and EU to assess the safety, tolerability, and efficacy of SENS-501 intra-cochlear injection in individuals with otoferlin gene-mediated hearing loss.
The research collaboration resulted in a second gene therapy study with GJB2-GT, which was launched in 2021 and had a therapeutic candidate in preclinical development as of April 2023. GJB2-GT targets deafness caused by mutations in the GJB2 gene, which is the most frequent form of childhood deafness. Three indications, all associated with GJB2 mutations, are currently being investigated: early presbycusis, progressive hearing loss during childhood, and congenital hearing loss.
Over the last 25 years, the Institut Pasteur has developed world-renowned expertise in the physiology and molecular pathophysiology of the auditory system, beginning with work at the Institut Pasteur's Genetics and Physiology of Hearing Unit, led by Professor Christine Petit, and continuing at the Hearing Institute, a research center of the Institut Pasteur.