CombiGene AB

Plus, news about Novartis, CombiGene, ProQR and Aardvark Therapeutics: Biogen presents full Phase 2 data for felzartamab: The drug, which was acquired in Biogen’s $1.15 billion buyout of HI-Bio earlier this year, showed patients with IgA nephropathy maintaining a 50% average reduction in a measurement of kidney stabilization after two years. Biogen expects to take the drug into a Phase 3 study but exact details have not yet been disclosed. — Max Gelman Sanofi snags equity in Resalis Therapeutics for undisclosed amount: The new tranche of cash will help the biotech pay for a Phase 2 proof-of-concept study of its lead obesity medicine, called RES-010. Resalis raised €10 million ($10.8 million) in early 2024 to afford the drug’s first obesity trial. — Max Bayer Novartis shares one-year data for Fabhalta in ultra-rare kidney disease: For patients with C3 glomerulopathy, Fabhalta at 12 months sustained reductions in proteinuria that had been seen at six months, when the study reported a 35.1% reduction in protein buildup in the urine compared to placebo. At six months, patients who received placebo in the Phase 3 study were switched over to iptacopan, which Novartis markets as Fabhalta for a rare blood disorder and an autoimmune kidney disease. Novartis submitted the drug for approval in C3G in the EU, China and Japan, and it expects to be in the US by the end of this year. — Lei Lei Wu CombiGene trims pipeline, headcount: The Swedish drugmaker is ending work on its gene therapy candidate for epilepsy, called CG01, and instead prioritizing its chronic pain program, dubbed COZY. CombiGene is also reducing the number of its employees and external consultants by 45% in a bid to extend its cash runway through the second quarter of 2026. It had 11 employees, as of December 2023. — Ayisha Sharma Eli Lilly invests in ProQR as it nabs $75.3M: The company is selling shares for $3.50 apiece, getting $63 million. In addition, the funding includes a private placement from Eli Lilly that totals $12.3 million. — Max Gelman Aardvark Therapeutics buys MEI Pharma’s solid tumor drug: The San Diego-based biotech paid $500,000 upfront for the rights to MEI’s ME-344, an inhibitor of mitochondrial oxidative phosphorylation. MEI is eligible for up to $62 million in milestones. — Ayisha Sharma

OXFORD, United Kingdom, April 29, 2024 (GLOBE NEWSWIRE) -- Evox Therapeutics Ltd (‘Evox’ or the ‘Company’), a leading exosome therapeutics company, announces that Dr. Per Lundin, Co-Founder and Chief Business Officer, has been appointed as Chief Executive Officer (CEO) of the Company and will be appointed to its Board of Directors. Following more than six years with the Company, Dr. Antonin “Tony” de Fougerolles has decided to step down as CEO and Director of Evox. Tony will continue to support the Company as a strategic adviser. Per has more than 15 years’ experience founding, leading, and advising biotech companies developing advanced therapies, including co-founding Evox in 2016. Prior to Evox, he founded and led IsletOne Therapeutics, a cell therapy company developing allogeneic cell therapies for autoimmune and inflammatory diseases, and prior to that worked in business development and as an IP attorney in a leading European law firm. Per serves as non-executive director of publicly listed gene therapy company Combigene and research committee member and board director of JDRF International and JDRF UK, respectively. He is a qualified European Patent Attorney with extensive leadership, business development and operational experience; he earned his PhD from the Karolinska Institute, his Master of Science in Biotechnology Engineering from the Royal Institute of Technology, and his Master of Business Administration from Stockholm University School of Business. Per takes on the role of CEO having founded the Company in 2016 and worked closely with Tony over the last six and a half years to significantly progress the business. Evox is backed by leading venture capital investors and has since inception developed a proprietary exosome therapeutics platform technology, entered into a number of collaborations with renowned institutions and pharma companies, developed a dominant IP estate and advanced the Company’s proprietary pipeline towards the clinic. “On behalf of the Board and the whole Evox team, I would like to thank Tony for his leadership and commitment to driving the Company and its innovative technology forward, and wish him all the best in the next phase of his career,” said Paul Carter, Non-Executive Chairman of Evox Therapeutics. “Per’s strategic insight and wide-ranging experience will be invaluable as he leads Evox through its next phase of growth. Furthermore, as Co-Founder of the business, he has a deep understanding of Evox and its exosome platform.” “Over the past six and a half years as CEO, I am extremely proud of the progress we have made to uncover the enormous potential of exosome therapeutics,” said Dr. Antonin de Fougerolles, outgoing CEO. “The Company has a very promising future ahead and I look forward to continuing to support Evox’s journey in an advisory role.” Per Lundin, PhD, Chief Executive Officer and Co-Founder of Evox Therapeutics, added: “I have enjoyed working closely with Tony over the years and I look forward to leading the Company as we advance our cutting-edge technology, DeliverEX®, to accelerate the development of exosome-enabled genetic medicines.” About Evox Therapeutics Evox Therapeutics is a privately held, Oxford-based biotechnology company that is a leader in harnessing and engineering the natural delivery capabilities of exosomes to create and enable the next generation of genetic medicines. Evox uses its DeliverEX® platform to engineer exosomes to facilitate safe and precise drug delivery to hard-to-reach organs and tissues. The Company holds an unrivalled intellectual property estate across non-viral genetic medicines and is backed by leading life sciences venture capital groups, including Oxford Science Enterprises, Redmile, OrbiMed and GV. For media enquiries, please contact: Media:Simon Conway / Natalie Garland-CollinsEvoxTherapeutics@fticonsulting.com +44 (0) 203 727 1000 For further information visit: www.evoxtherapeutics.com

中国脑计划项目作为一个十五年计划（2016—2030年），在“十四五”规划中已上升至国家战略地位。其中，脑疾病的诊断与治疗是“中国脑计划”的重要应用方向之一，针对的是诸如孤独症、抑郁、阿尔兹海默症、帕金森等重大脑功能障碍与神经衰退性疾病的早期诊断、干预手段研发、药物研发等。与此同时，中国康复医疗发展也驶入快车道，康复专科化建设、互联网+居家康复医疗服务体系建设等得到国家重视。据不完全统计，我国几大功能性神经疾病患者群体总数已突破5000万且发病率在逐年增高，脑功能疾病诊断、治疗的市场可达千亿规模。同时，疾病超高的致残率、致畸率、致死率给家庭和国家带来了巨大的社会负担。早诊断、早干预、早康复成为重中之重。但在临床治疗中，此类药物开发及药物治疗效果并不理想。因此，引入多场景用非侵入型经颅电磁技术进行疾病干预成为目前的优选方案。洛阳康贝生物工程有限公司（简称“康贝生物”）成立于2001年，是国内最早研发且把非侵入性电磁治疗技术应用于脑功能疾病治疗的生产企业。相关产品经颅电磁康复治疗仪早在2006年就获得国家发明专利。目前，该产品已经在全国二十多个省份、近千家医院做临床应用，反馈良好，并且已形成商品化、系列化生产，广泛应用于不同规模的医院和社区门诊开展对脑疾病的康复治疗。新掌门带来新活力2018年5月，康贝生物迎来新任总经理王金伟，也自此开启了升级转型之路。王金伟毕业于郑州大学临床医学系。过去20几年，他曾先后在美国礼来、强生、巴德等跨国医疗企业历经锤炼，直至担任重要管理职位。接手康贝生物，无论是对公司还是对王金伟本人来说，都是一次蜕变。康贝生物总经理王金伟“从统领销售部门转向生产企业经营管理的跨度其实很大。销售只是生产企业的一个环节。但对于生产企业来说，质量、技术、研发、生产、销售、售后等环节需要做到有机结合。还有更繁琐、复杂、系统的管理工作要处理。所以接管公司后，我经历了半年左右的沉淀期，去了解公司内外情况。”王金伟说道。作为一家研发生产型企业，技术才是企业持续具有生命力的基石。王金伟发现，公司在技术方面有很深的积淀，但是苦于找不到突破点，且公司的发明专利数量有待提升，于是在2019年新增了企业规划——依托现有技术，找到创新点。在常创常新的思路指引下，康贝生物成功申请两项发明专利以及其他20多项实用新型专利，并获得国家高新技术企业称号。在此基础上，公司与河南科技大学进行产学研结合，联合参加了河南省科技攻关项目《经颅磁联合脑电的临床项目评价》，目前该项目已结题并获得证书。与此同时，公司在中国（洛阳）工业设计产业技术发展大会上和郑州沐客也正式签约，对产品进行“美颜”升级。那段时间，王金伟还带领公司厘清了新的战略定位和发展方向。经历20年的蛰伏积淀后，康贝生物自此迎来了新定位——立志成为脑功能诊断和治疗领域具有重要影响力的多元化医疗产业集团，并从三大维度开启了升级转型之旅。第一：产品小型化，为康复黄金期助力。王金伟告诉动脉网，90%的脑功能疾病患者治疗离院后最大的康复场景是居家。但在居家的前六个月康复黄金期，他们往往受限于科学有效的康复措施和治疗方式。因此，秉承“错过了预防，不要再错过治疗黄金期”的理念，康贝生物于2019年启动经颅电磁治疗设备的小型化研发，并于2020年完成产品下线，2021年获得二类医疗器械注册证。此举为康贝生物实现居家脑功能康复奠定了基础，扩大了产品的应用场景，让患者能够实现序贯治疗，在黄金期内“疗”有所依。康贝生物经颅电磁康复治疗仪便携机第二：销售模式转型，让更多的伙伴助力患者康复。过去的20年，康贝生物一直是一家以直销为主的企业，这个过程消耗了大量的人力和精力。随着市场环境及外部政策的变化，只有进行商业渠道分销模式转型，释放活力，得到有能力合作伙伴的协助，才能把企业做大做强，实现合作共赢，树立康贝中磁的品牌形象。为此，王金伟在2019年跑遍了中国20个省份，找到近百家经销商谈合作，奠定了康贝生物发展转型的基础。迄今为止，合作的经销商已经有800多家，更多的客户在认识康贝，了解康贝，选择康贝。第三：产线扩大化，为康复患者提供更多质优产品。站在未来看现在，康贝生物若想成长为一家集团型企业，还要在现有业务基础和技术积淀之上，提前布局新赛道，避免单一产品带来的商业风险。据悉，康贝生物除掌握经颅磁、经颅电技术外，还增加了睡眠诊断技术、经颅电治疗技术的升级、院内院外序贯治疗平台、认知障碍诊疗工作站、孤独症、睡眠障碍、偏头痛、脑供血不足等常见病治疗产品的技术储备均已完成。  定位中高磁技术，打造多功能智能化康复一体机经颅电磁治疗设备适用的脑功能疾病涉及儿童、成人、老人三大群体以及儿童科、儿童精神心理科、神经内科、神经外科、精神科、睡眠中心、老年科、康复科等七大科室。常见的有多动症、孤独症、脑卒中、抑郁症、焦虑症、睡眠障碍、阿尔兹海默症等。这些疾病的康复治疗手段目前最常用的方式是药物治疗、物理治疗或行为疗法。从本质上看，物理治疗或行为疗法更多的是对症治疗。而疾病实际病区是在大脑，直接针对大脑进行干预的对因治疗方式则相对有所缺失。近十年来，随着脑科学研究的深入发展，随着科学技术的进步，对因治疗的手段也逐渐成熟，其中最为常见的为侵入式和非侵入式两种。侵入式治疗需要将神经刺激器植入脑内，常用于癫痫、帕金森等疾病的干预。但该治疗方式风险性相对较高，且只能通过外科手术植入，使用具有局限性。非侵入式的经颅磁、电刺激，通过外加电场改变神经元的生物活性，也被验证对于一些脑疾病的治疗大有裨益，技术与应用日渐成熟。康贝生物作为国内最早研发且把非侵入性电磁治疗技术应用于脑功能疾病治疗的生产企业，依据磁电特性、市场需求、NMPA规定（磁疗产品注册技术审查申报产品磁场强度安全值为200mT），成功研发出了能同时刺激大脑和小脑区域的磁电联合中枢干预技术。而且通过特殊的技术方式，将康贝经颅电磁场最大调整到160mT，实现了经颅中高磁技术，让产品在治疗中更有效、更安全。康贝生物经颅电磁多功能康复治疗仪以中高磁为基础设计的康贝生物经颅电磁多功能康复治疗仪，可以对患者的额叶、顶叶、枕叶和颞叶等大脑皮层及小脑等功能区进行全脑刺激，形成了中枢-外周-中枢的一个闭环康复治疗体系。磁电联合治疗效果更有保障，治疗过程更为安全、使用范围及适用人群更为广泛。多年来，康贝经颅磁一直进行技术更新与产品迭代升级，将经颅电磁康复治疗仪由原来笨重的按键式升级为当前智能四功能合一设备，打造出集经颅磁治疗仪、经颅电治疗、神经肌电治疗（中低频治疗仪）、颈部肌电治疗（吞咽治疗仪）四种功能为一体的自动识别智能型经颅电磁康复治疗仪。康贝生物经颅电磁多功能康复治疗仪同时，与强磁治疗产品相比，康贝生物经颅电磁多功能康复治疗仪通过技术改良，可以自然冷却线圈，避免了线圈发热对患者造成的安全隐患，也省去了强磁设备降温装置的固有成本，在产品定价上具有明显优势。目前，康贝生物经颅电磁多功能康复治疗仪产品已在市场上服务于全国一千多家医疗机构，每天为近万名患者提供治疗服务，全国合作经销商八百余家。院内市场一直是康贝生物的根基，下一步则是积极拓展院外市场。 谋定而后动：做技术融合，打产品组合“作为一个生产企业，我们的定位就是——研发技术创新性的产品、打造康贝生物良好的行业品牌、为各级客户提供完善细致及时的售后服务，这三点始终坚定不移。”王金伟说道。他表示，既然立志要成为脑功能诊断和治疗领域具有重要影响力的多元化医疗产业集团，产品就要围绕为脑功能疾病的诊断和治疗做深度和广度开发，做技术融合、产品融合、产品组合。在市场方面，康贝将更加关注脑功能疾病的医用市场及家用市场，让更多需要脑功能康复的患者能够实现院内院外的序贯治疗。此外，在睡眠障碍人群已经突破3亿的大环境下，康贝生物也正为睡眠中心打造一款睡眠诊疗一体化的产品，并进行信息化升级，构建医用和家用产品连接平台。经颅电磁多功能康复治疗仪产品也可以和认知功能数字疗法产品做技术融合，增强干预效果。同时针对脑供血不足、偏头痛等疾病的诊断和治疗，康贝生物也在做技术升级以及新产品注册。康贝生物始终朝着“专精特新小巨人”方向努力，已符合基本认定条件。公司还成功入围“第七届清华校友三创大赛晋级赛”总决赛，与河南科技大学第一附属医院、郑州大学第一附属医院、郑州大学第二附属医院、郑州大学第五附属医院、河南省中医一附院、河南省中医二附院、陕西省人民医院、江苏省人民医院、山西医科大学第二医院等标杆医院达成了深度合作。据了解，康贝生物已正式启动首轮融资计划，用于产品研发注册及市场运营投入。“康贝生物始终把技术性工作做得很扎实，一切就绪后，可以立即启动信息化建设、技术落地及产品落地，三年之内有望拿到五个注册证。”王金伟说道。想要联系动脉网报道的企业，请点击文末左下方“阅读原文”填写表单，我们的工作人员将征求企业意见后，尽快为您服务。左右滑动查看更多近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台