- The framework extension agreement underlines the successful
collaboration between Sensorion and the Institut Pasteur, involving
the Hearing Institute, a research center of the Institut Pasteur,
focused on the development of gene therapy programs
- Two gene therapy development programs are currently being
conducted under this agreement, including SENS-501 (OTOF-GT) and
GJB2-GT. Sensorion submitted a Clinical Trial Application in July
2023 for SENS-501 to initiate a Phase 1/2 clinical trial in the
United Kingdom (UK) and in the European Union (EU)
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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Investor Relations Noemie Djokovic, Investor Relations
and Communications Associate ir.contact@sensorion-pharma.com
International Media Relations Ulysse Communication
Pierre-Louis Germain / 00 33 (0)6 64 79 97 51
plgermain@ulysse-communication.com
Bruno Arabian / 00 (0)6 87 88 47 26
barabian@ulysse-communication.com
Institut Pasteur: Margaux Puech Pays d’Alissac Myriam
Rebeyrotte Aurélie Perthuison presse@pasteur.fr
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