MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announces that the research partnership framework agreement signed in 2019 with the Institut Pasteur1 (Paris, France) granting Sensorion an option for exclusive licenses to develop and market gene therapy drug candidates from collaborative projects to address unmet medical needs in the hearing field has been extended for a period of five years. The agreement has been amended to be extended up to December 31, 2028, to promote additional development gene therapy programs.
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. A Clinical Trial Application (Audiogene, Phase 1/2 clinical study) has been submitted in July 2023 in the UK and in the EU to evaluate the safety, tolerability, and efficacy of intra-cochlear injection of SENS-501 in patients suffering from otoferlin gene-mediated hearing loss.
The research partnership successfully led to a second gene therapy program with GJB2-GT, announced in 2021, for which a drug candidate, selected in April 2023, is currently in preclinical development. GJB2-GT targets deafness linked to mutations in the GJB2 gene, the most common form of childhood deafness. Three indications, all linked to GJB2 mutations, are currently being evaluated: early presbycusis, progressive hearing loss during childhood, and congenital hearing loss.
Over the past 25 years, the Institut Pasteur, has developed world-renowned expertise in the physiology and molecular pathophysiology of the auditory system with work carried out within the Institut Pasteur 's Genetics and Physiology of Hearing Unit, headed by Professor Christine Petit, and continuing within the Hearing Institute, a research center of the Institut Pasteur.
Sensorion has a preferential right on other Institut Pasteur preclinical research programs in the field of genetic diseases of the inner ear, with a view to establishing potential new collaborations.
Professor Christine Petit, Professor at the Institut Pasteur and Professor Emeritus at the Collège de France, France, Winner of the Kavli Prize in 2018, comments: "I am very satisfied with the progress of the partnership between the Institut Pasteur and Sensorion, and I am delighted that it has been extended. Over the past four years, our teams have achieved major milestones, enabling us to reach the clinical stage with our first gene therapy drug candidate in the field of deafness. We still have many challenges ahead of us to transform these scientific advances into innovations for the benefit of patients, whether in terms of advancing diagnosis and patient care, or developing curative treatments for hearing impairment."
Nawal Ouzren, Sensorion's Chief Executive Officer, adds: "By building on our partnership with the Institut Pasteur and its world-renowned scientific teams, and on the excellence of our development and production know-how, we have achieved, in just four years, a strategic turning point which today positions Sensorion among the leading players in gene therapy applied to hearing disorders. We are convinced that the continuation of the fruitful collaboration between the Institut Pasteur and Sensorion will contribute to the emergence of revolutionary new therapies for thousands of patients suffering from congenital deafness today."
About Sensorion
Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat, and prevent hearing loss disorders, a significant global unmet medical need.
Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and mechanisms of action for drug candidates. It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness, developed in the framework of its broad strategic collaboration focused on the genetics of hearing with the Institut Pasteur. SENS-501 (OTOF-GT) targets deafness caused by mutations of the gene encoding for otoferlin and GJB2-GT targets hearing loss related to mutations in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses.
Sensorion’s portfolio also comprises clinical-stage small molecule programs for the treatment and prevention of hearing loss disorders. Sensorion’s clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a planned Phase 2 proof of concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, in a study of SENS-401 in patients scheduled for cochlear implantation. A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022.
www.sensorion.com
About Institut Pasteur
The Institut Pasteur, a non-profit foundation with recognized charitable status set up by Louis Pasteur in 1887, is today an internationally renowned center for biomedical research. In the pursuit of its mission to tackle diseases in France and throughout the world, the Institut Pasteur operates in four main areas: research, public health, training, and development of research applications. The Institut Pasteur is a globally recognized leader in infectious diseases, microbiology, and immunology, with research focusing on the biology of living systems. Among its areas of investigation are emerging infectious diseases, antimicrobial resistance, certain cancers, neurodegenerative diseases, and brain connectivity disorders. The Institut Pasteur's outstanding research is facilitated by the development of a technological environment of the highest standard, with core facilities for nanoimaging, computational biology and artificial intelligence. Since its inception, 10 Institut Pasteur scientists have been awarded the Nobel Prize for Medicine, including two in 2008 for the 1983 discovery of the human immunodeficiency virus (HIV) that causes AIDS.
The Institut Pasteur is part of the Pasteur Network, a worldwide network of more than 30 members on five continents, united by Pasteurian values, that contribute to global health.
Since July 1, 2021, the Institut Pasteur is a research partner organization of Université Paris Cité.
www.pasteur.fr
Label: SENSORION
ISIN: FR0012596468
Mnemonic: ALSEN
Disclaimer
This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2022 full year financial report published on March 30, 2023, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance, or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.
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1 https://www.sensorion.com/en/category/press-releases/