MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:

法国蒙彼利埃——（商业新闻短讯）——监管新闻：

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.

Sension（FR0012596468–ALSEN）是一家开创性的临床阶段生物技术公司，专门开发新疗法，以恢复、治疗和预防听力损失疾病，今天宣布，2019年与巴斯德研究所（法国巴黎）签署的研究伙伴关系框架协议授予Sension独家许可的选择权，以开发和销售合作项目中的基因治疗候选药物，以解决听力领域未满足的医疗需求，该协议已延长五年。

The agreement has been amended to be extended up to December 31, 2028, to promote additional development gene therapy programs..

该协议已被修订，延长至2028年12月31日，以促进额外的开发基因治疗计划。。

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.

SENS-501是该合作伙伴关系中最先进的计划，该计划针对由编码otoferlin的基因突变引起的耳聋，于2019年被确定为优先事项，已达到其目标。在Sension和巴斯德研究所（Institut Pasteur）合作的框架下，成功完成了疗效临床前包，将OTOF-GT产品（SENS-501）的开发推向了临床阶段。

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..

2023年7月，英国和欧盟提交了一项临床试验申请（Audiogene，1/2期临床研究），以评估耳蜗内注射SENS-501对耳蜗素基因介导的听力损失患者的安全性，耐受性和有效性。。

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.

该研究伙伴关系成功地导致了2021年宣布的与GJB2-GT的第二个基因治疗计划，2023年4月选择的候选药物目前正在临床前开发中。GJB2-GT靶向与GJB2基因突变相关的耳聋，GJB2基因是儿童耳聋的最常见形式。

Three indications, all linked to GJB2 mutations, are currently being evaluated: early presbycusis, progressive hearing loss during childhood, and congenital hearing loss..

目前正在评估三种与GJB2突变有关的适应症：早期老年性耳聋，儿童期进行性听力损失和先天性听力损失。。

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..

在过去的25年中，巴斯德研究所在听觉系统的生理学和分子病理生理学方面发展了世界知名的专业知识，在巴斯德研究所的遗传学和听觉生理学部门开展了工作，由克里斯蒂娜·佩蒂教授领导，并继续在巴斯德研究所的研究中心听力研究所开展工作。。

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.

Sension在巴斯德研究所内耳遗传疾病领域的其他临床前研究项目中享有优先权，以期建立潜在的新合作。

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.

巴斯德研究所（Institute Pasteur）教授、法国法兰西学院（Collège de France）荣誉退休教授克里斯蒂娜·佩蒂（Christine Petit）教授评论道：“我对巴斯德研究所（Institute Pasteur）与传感（Sensorion）之间的合作进展感到非常满意，我很高兴它得到了扩展。

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.'.

在过去的四年中，我们的团队取得了重大的里程碑，使我们能够凭借耳聋领域的第一个基因治疗候选药物进入临床阶段。无论是在推进诊断和患者护理方面，还是在开发听力障碍的治疗方法方面，我们仍然面临着许多挑战，如何将这些科学进步转化为创新，以造福患者。”。

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.

Sension首席执行官纳瓦尔·乌兹伦（Nawal Ouzren）补充道：“通过与巴斯德研究所及其世界知名的科学团队建立合作关系，以及凭借我们卓越的开发和生产技能，我们在短短四年内实现了一个战略转折点，今天，Sension在应用于听力障碍的基因治疗领域处于领先地位。

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.'.

我们相信，巴斯德研究所和Sension之间继续进行富有成效的合作，将有助于为今天数千名先天性耳聋患者提供革命性的新疗法。”。

About Sensorion

关于Sension

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.

Sension是一家开创性的临床阶段生物技术公司，专门开发新疗法，以恢复，治疗和预防听力损失障碍，这是一项重大的全球未满足的医疗需求。

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.

Sension建立了一个独特的研发技术平台，以扩大其对内耳相关疾病的病理生理学和病因学的理解，使其能够为候选药物选择最佳的靶标和作用机制。它有两个基因治疗计划，旨在纠正遗传性单基因形式的耳聋，这是在其与巴斯德研究所（InstitutPasteur）的广泛战略合作框架内开发的，重点是听力遗传学。

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..

SENS-501（OTOF-GT）靶向由编码otoferlin的基因突变引起的耳聋，GJB2-GT靶向与GJB2基因突变相关的听力损失，以潜在地解决成人和儿童的重要听力损失部分。该公司还致力于鉴定生物标志物，以改善对这些服务不足疾病的诊断。。

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.

Sension的投资组合还包括用于治疗和预防听力损失障碍的临床阶段小分子计划。Sension的临床阶段产品组合包括一个第二阶段产品：SENS-401（Arazasetron），正在计划的第二阶段SENS-401在顺铂诱导的耳毒性（CIO）中的概念验证临床研究中取得进展，并且与合作伙伴Cochlear Limited合作，在计划进行人工耳蜗植入的患者中进行SENS-401的研究。

A Phase 2 study of SENS-401 was also completed in Sudden Sensorineural Hearing Loss (SSNHL) in January 2022..

SENS-401的第二阶段研究也于2022年1月在突发性感音神经性听力损失（SSNHL）中完成。。

www.sensorion.com

www.sensorion.com

About Institut Pasteur

巴斯德研究所简介

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.

巴斯德研究所（InstitutPasteur）是路易·巴斯德（LouisPasteur）于1887年成立的一家具有公认慈善地位的非营利性基金会，如今已成为国际知名的生物医学研究中心。巴斯德研究所（Institut Pasteur）致力于在法国和全世界应对疾病，主要在四个领域开展业务：研究、公共卫生、培训和研究应用开发。

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.

巴斯德研究所（InstitutPasteur）是全球公认的传染病、微生物学和免疫学领域的领导者，其研究重点是生命系统的生物学。其研究领域包括新兴传染病，抗菌素耐药性，某些癌症，神经退行性疾病和大脑连接障碍。

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..

巴斯德研究所（InstitutPasteur）的杰出研究得益于最高标准技术环境的发展，其核心设施包括纳米成像、计算生物学和人工智能。自成立以来，巴斯德研究所（InstitutPasteur）已有10位科学家获得诺贝尔医学奖，其中两位于2008年因1983年发现导致艾滋病的人类免疫缺陷病毒（HIV）而获奖。。

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.

巴斯德研究所是巴斯德网络的一部分，巴斯德网络是由五大洲的30多个成员组成的全球网络，由巴斯德的价值观团结在一起，为全球健康做出贡献。

Since July 1, 2021, the Institut Pasteur is a research partner organization of Université Paris Cité.

自2021年7月1日以来，巴斯德研究所是巴黎城市大学的研究合作伙伴组织。

www.pasteur.fr

www.pasteur.fr

Label: SENSORION

标签：SENSORION

ISIN: FR0012596468

ISIN:FR0012596468

Mnemonic: ALSEN

助记符：ALSEN

Disclaimer

免责声明

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.

本新闻稿包含有关Sension及其业务的某些前瞻性声明。此类前瞻性陈述基于Sension认为合理的假设。然而，无法保证此类前瞻性报表会得到验证，这些报表会面临许多风险，包括2023年3月30日发布的2022年全年财务报告中规定的风险，这些风险可在我们的网站上查阅，也无法保证经济状况、金融市场和Sension运营所在市场的发展。

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.

本新闻稿中包含的前瞻性声明也会面临Sension尚不知道或Sension目前认为不重要的风险。所有或部分此类风险的发生可能导致实际结果、财务状况、业绩或感知成就与此类前瞻性报表存在重大差异。

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.

本新闻稿及其包含的信息不构成任何国家出售或认购Sension股份的要约，也不构成任何国家购买或认购Sension股份的要约。在某些国家传播本新闻稿可能违反当地法律法规。

Any recipient of this press release must inform oneself of any such local restrictions and comply therewith..

本新闻稿的任何接收者必须告知自己任何此类当地限制并遵守。。

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1 https://www.sensorion.com/en/category/press-releases/

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