Amal Therapeutics SA

AC Immune Strengthens Management, Appoints Madiha Derouazi as CSO and Christopher Roberts as CFO Outstanding scientist and entrepreneur Dr. Madiha Derouazi appointed as new CSORetiring CSO Dr. Marie Kosco-Vilbois will remain as consultant to ensure smooth handoverChristopher Roberts, Interim Chief Financial Officer, confirmed in role on a permanent basis Lausanne, Switzerland, December 1, 2023 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced the appointment, as of January 1st, 2024, of Dr. Madiha Derouazi as Chief Scientific Officer and the promotion of Interim Chief Financial Officer Christopher Roberts to Chief Financial Officer. Dr. Derouazi succeeds the former CSO, Dr. Marie Kosco-Vilbois, who is retiring and will remain with AC Immune as an expert consultant in immunology to ensure continuity and a smooth transition. Dr. Madiha Derouazi, an accomplished immunologist, joins from Speransa Therapeutics where she had been CEO since inception in 2021, leading development of a novel platform of prophylactic vaccines. Previously, she founded AMAL Therapeutics in 2012, an immuno-oncology company developing a new generation of therapeutic cancer vaccines, and served as CEO and CSO of the company until 2022. Dr. Derouazi led AMAL’s acquisition by Boehringer Ingelheim for EUR 425 million in 2019. She holds a PhD in Cellular Biotechnology from the Swiss Federal Institute of Technology (EPFL) in Lausanne which was followed by postdoctoral work concentrating on tumor immunology and vaccine development. Christopher Roberts joined AC Immune in 2019 and has served as Vice President, Finance and Interim CFO of AC Immune since 2022. He has extensive experience of SEC reporting, initial and follow-on public offerings and financial controls. He is a UK Chartered Accountant and holds a Bachelor of Science in Accounting, Auditing and Finance from Lancaster University. Dr. Andrea Pfeifer, CEO of AC Immune SA, commented: “I am delighted to welcome Madiha Derouazi as our new CSO and to confirm Chris as CFO. Madiha has an outstanding international track record as an immunologist, entrepreneur, and vaccine developer. Her expertise in vaccines will be invaluable to AC Immune as we continue to transform our company into a global leader in precision medicine to diagnose, treat and prevent neurodegenerative diseases with active immunotherapies and other therapeutic modalities.” “I would like to take this opportunity to warmly thank Marie for her dedicated service to AC Immune. Her experience has proven instrumental for optimizing our SupraAntigen vaccine technology platform as we have expanded and developed our broad pipeline. We wish her all the best for the future.” About AC Immune SA AC Immune SA is a clinical-stage biopharmaceutical company that aims to become a global leader in precision medicine for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and NeuroOrphan indications driven by misfolded proteins. The Company’s two clinically validated technology platforms, SupraAntigen® and Morphomer®, fuel its broad and diversified pipeline of first- and best-in-class assets, which currently features ten therapeutic and three diagnostic candidates, five of which are currently in Phase 2 clinical trials and one of which is in Phase 3. AC Immune has a strong track record of securing strategic partnerships with leading global pharmaceutical companies including Genentech, a member of the Roche Group, Eli Lilly and Company, and others, resulting in substantial non-dilutive funding to advance its proprietary programs and >$3 billion in potential milestone payments. SupraAntigen® is a registered trademark of AC Immune SA in the following territories: AU, EU, CH, GB, JP, RU, SG and USA. Morphomer® is a registered trademark of AC Immune SA in CN, CH, GB, JP, KR, NO and RU. The information on our website and any other websites referenced herein is expressly not incorporated by reference into, and does not constitute a part of, this press release. For further information, please contact: Head of Investor Relations & Corporate CommunicationsGary Waanders, Ph.D., MBAAC ImmunePhone: +41 21 345 91 91Email: gary.waanders@acimmune.comU.S. InvestorsCorey Davis, Ph.D.LifeSci AdvisorsPhone: +1 212 915 2577 Email: cdavis@lifesciadvisors.comInternational MediaChris MaggosCohesion BureauPhone: +41 79 367 6254Email: chris.maggos@cohesionbureau.com Forward looking statementsThis press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement. Attachments 20231201_ACIU_Management change-FINAL AC Immune appoints Madiha Derouazi as CSO AC Immune appoints Christopher Roberts as CFO

正文共：3141字预计阅读时间：10分钟时不时在皮肤各处出现大片脓疱以及溃烂，并有痛感，甚至伴发高热，脓疱退痂时，浑身又会出现剧烈瘙痒……这是泛发性脓疱型银屑病（GPP）患者的真实经历。在中国，每十万人中有1~2人可能会患有GPP，这也使得在临床上，GPP容易出现误诊、漏诊。即便能够确诊，患者依旧面临着治疗难、用药难的双“难”困境。今年5月，勃林格殷格翰的泛发性脓疱型银屑病治疗药物佩索利单抗（spesolimab，商品名 圣利卓®）正式上市，中国的泛发性脓疱型银屑病患者面临的临床难题得到有效改观。在勃林格殷格翰中国医学团队与监管部门、临床机构乃至患者群体的共同努力下，佩索利单抗在中国区的研发、注册、获批与全球进展完全同步，以“零时差”惠及中国患者。这是“2023勃林格殷格翰中国研发日”上，勃林格殷格翰团队就“以患者为中心”分享的其中一个案例。会后，药时代采访勃林格殷格翰大中华区研发和医学高级副总裁张维博士，就行业所关心的外部合作创新、如何进行以患者为中心的药物开发和GCG/GLP-1双受体激动剂研发进展等话题展开讨论，以下为采访内容整理。张维博士勃林格殷格翰大中华区研发和医学高级副总裁DrugTimes勃林格殷格翰的外部创新与中国本土合作Q此前药时代曾采访勃林格殷格翰的全球创新事业部负责人Michel Pairet博士，他曾提到过，勃林格殷格翰的一个重要目标是——未来将有50%的管线来自外部创新，今天在研发日上您也提到了这一点。您认为合作在生物医药创新生态的作用和影响有哪些？A勃林格殷格翰的全球转化医学和临床药理部负责人Florian Gantner博士在他的讲演里提及，99.99%甚至更多的创新是发生在勃林格殷格翰之外。勃林格殷格翰在全球有53000名员工，上千人的科学家团队，但仅凭勃林格殷格翰的能力是有限的，我们需要汇集全球最顶尖的科学家团队，最专业的临床专家，也需要跟监管机构做好沟通交流，才能够推进药物创新。药物研发不是单打独斗，我们需要携手各方面的合作伙伴，没有这些合作的话，勃林格殷格翰也会举步维艰。目前勃林格殷格翰的管线中，67%的产品属于同类首创，82%的产品具有突破性疗法潜力，这与我们合作伙伴的努力密不可分。Q您能否分享一些勃林格殷格翰的优秀外部创新案例？勃林格殷格翰希望后续能够在哪些领域，和其他企业、研发机构达成合作？A研发日上谈到的勃林格殷格翰的肿瘤合作，是我们与外部企业合作搭建了一个创新技术平台，共同利用此类创新技术孵化肿瘤创新疗法（包括与NBE therapeutics公司在ADC领域的合作，以及与ViraTherapeutics公司在溶瘤病毒领域的药物开发，与AMAL Therapeutics公司在癌症疫苗领域的研发等），旨在尽早将肿瘤领域的创新成果带给患者，解决目前高度未被满足的临床需求。我还可以介绍一下勃林格殷格翰和中国企业开展外部合作的优秀案例。一个是我们与三迭纪就3D打印药物达成了合作。另一个是和燃石医学就肿瘤伴随诊断方面达成合作。勃林格殷格翰与燃石医学共同合作进行MDM2-p53拮抗剂brigimadlin针对去分化脂肪肉瘤患者的伴随诊断试剂的临床开发，燃石医学在该领域取得了非常不错的成就，今天我们就在这里同他们举行了签约仪式。勃林格殷格翰不仅会与其他合作伙伴就单个药物进行合作，有时候也会就创新平台进行合作，共同孵化创新疗法。我们同样期待在各个领域继续深化多元合作，就像本次研发日的主题“研无界，惠众生”一样。因为在任何一个领域，即便勃林格殷格翰处于领先梯队，也有待完善和提升的空间。勃林格殷格翰在药物研发中如何体现“以患者为中心”Q勃林格殷格翰是如何对管线进行筛选的？A勃林格殷格翰现有五大治疗领域，每个治疗领域的研发各有千秋，考量点不同。但有一点是不变的，勃林格殷格翰以患者为中心进行创新药物研发。不管是针对全球有超过十亿患者的心肾代谢疾病，还是针对发病率只有十万分之一二的泛发性脓疱型银屑病，我们关注的是哪个领域能够真正发力，带来改变生命的治疗方式。我们应该时常问自己三个问题：第一，我们有没有做到以患者为中心？第二，我们是不是以临床价值来引导药物开发？第三，如果我们前两个问题的结论都是肯定的，那我们应该如何加速这个研发进程，来更早地惠及我们的患者？勃林格殷格翰是一个以研发为驱动的全球领先的生物制药企业，也是一家独立的家族企业，我们考虑的是世世代代的可持续发展。勃林格殷格翰目前正处于138年历史上的研发投入最高点，2022年全球人用药品业务研发投入达到了46亿欧元（较2021年增长了23.4%），勃林格殷格翰始终以患者为中心指导创新，不求一时的回报。Q勃林格殷格翰研发创新成果给中国医药行业与中国患者带来哪些获益？A我们进行的是“以患者为中心”的研发，临床需求始终是我们研究的出发点，临床价值是我们药物开发的最终目的，我们致力于将更多更好的创新药尽早地带给中国患者。在与全球同步研发过程中，中国患者的参与不仅体现在II/III期临床试验，在研适应症处于缺乏有效治疗方案或治疗手段有限的情况时，我们在中国的同步研发会始于更早期。勃林格殷格翰在考虑药物可及性时，也不仅仅针对药物上市后能让患者可以在第一时间用药。我们也在考虑，能否让中国的患者在临床阶段就能用到这些创新药。2018年，勃林格殷格翰的中国纳入项目让中国患者全部参加全球III期注册临床试验，2019年又升级到中国关键项目，让中国的患者更早地参加全球创新药物研究，在肿瘤领域我们甚至有在Ia期就有中国患者参与临床试验的实例。但是一木独秀不是林，勃林格殷格翰也不希望在患者获益方面，只有我们一家药企比较突出，在药物研发领域我们正与其他领导者们一起在全球同步研发这个方向努力。这可能就是勃林格殷格翰中国给整个行业的一个启示，也是我们对于同步研发这一块的些微作用与价值。在泛发性脓疱型银屑病预防方面，勃林格殷格翰在全球同步递交了注册申请，其中中国区是第一个递交的。作为跨国药企，勃林格殷格翰需要多方面、跨地域的合作，现在在中国我们也可以做到。当然要实现这种案例，可能需要天时地利人和，勃林格殷格翰的团队为此做出了巨大的努力，缺少任何一个条件都难以达成。基于这些优秀案例，我个人与团队也都积极在行业协会（比如Drug Information Association，DIA和RDPAC等）中跟同仁同道们一起沟通交流，希望共同打造一个药物研发的创新大环境，最终能够使中国患者获益。如何看待GLP-1赛道近期的火热Q勃林格殷格翰会专门挑选热门的赛道布局吗？您如何看待GLP-1赛道近期的火爆？A勃林格殷格翰不会盲目跟风热门赛道，并不是因为肥胖赛道突然的火热，才让我们开始相关药物研发。我也希望GLP-1赛道的火爆不是一时的热情，可以有一个可持续的投入。今年年底我们的GCG/GLP-1双受体激动剂survodutide针对肥胖适应证的全球III期临床试验就要启动了，这一研究项目在多年前就已开始。肥胖不是一个时尚、形体上的概念，而是一种疾病，并会关联影响到很多其他疾病，比如说心血管、肾脏和代谢等等慢性疾病，全球有十亿多人患有相互关联的心肾代谢疾病。勃林格殷格翰长期致力于心肾代谢（CRM）疾病领域的研究，在探索不同CRM疾病的机制和共同通路后，并寻找整体化解决方案。所以，勃林格殷格翰对于肥胖相关的疾病布局已久。而Zealand的GCG/GLP-1双受体激动剂与勃林格殷格翰的心肾代谢的研发策略相当契合，我们将Zealand的药物引入进来进行临床试验。这也是传统的生物制药公司与biotech双赢合作的一个很好的例子。Q在做肥胖适应证的临床研究时，在中国或全球有什么难点？A患者教育是临床试验的重要难题。研发日上我们也谈到过一个案例：因为受试者的邻居觉得受试者减得太瘦了，受外界风闻干扰，受试者就要中止参与临床试验。此时我们亟需对患者进行教育，“我参加这个临床研究纯粹是为了减肥获得一个好体型，还是说为了治疗疾病而参与药物研发呢？”勃林格殷格翰会一直强调，这是药物研发，而不是减肥项目。药物研发是要有科学的循证医学证据支持，需要患者持续坚持参与其中，贡献个人临床数据，来共同完成临床试验，获得最可靠的临床数据。中国是全球第二大药品研发大国，也是近年来全球医药研发市场中的一匹黑马。从2015年开始，中国药物研发管线整体增速保持在较高的水平，均超过30%；其中，2019年高达56%，远远高于全球整体水平。勃林格殷格翰中国通过“驷马高车”整体创新布局，践行总部携手“合作伙伴”实现外部创新的研发策略，进一步加强与中国本土创新力量的合作交流。勃林格殷格翰深知中国的创新能力和发展潜力，多年来勃林格殷格翰积极布局，深度参与中国研发创新的进步历程，今后将继续保持加码中国的战略定力，以研之无界，惠国之众生。

None  Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  Ayala sheds execs amid Advaxis merger  Advaxis, Ayala Pharmaceuticals  A new merger deal has Advaxis and Ayala joining forces, though not everyone from Ayala’s team will be coming with. Advaxis CEO Kenneth Berlin will guide the newly created company—which has yet to decide on a name—while Ayala CEO Roni Mamluk, Ph.D., will resign. That’s not the only Ayala loss, with CFO Yossi Maimon and CMO Gary Gordon, M.D., stepping down, though Gordon will remain in an advisory role “for a period of time.” The new company’s board will include two members designated by Advaxis and four chosen by Ayala alongside Berlin.  Each biotech will continue to propel its lead program, with the new company aiming to prioritize the development of AL102 to treat desmoid tumors and ADXS-504 for patients with prostate cancer. With only $20 million on hand, Ayala was facing a potential cash crunch. But Advaxis may have solved its problems—in return for the hope of a return to the Nasdaq after dropping from the leading stock exchange down to the OTC Markets in 2021. Fierce Biotech Scynexis CEO to retire amid strategic restructure, C-suite shake up Scynexis Scynexis is shedding C-suite execs as part of strategic restructuring that includes layoffs and slimming down its pipeline.  President and CEO Marco Taglietti, M.D., will retire after more than seven years leading the company, effective Dec. 31. He will also step down from the board of directors. Chief Medical Officer David Angulo, M.D., will take Taglietti’s spot after serving as CMO for the last seven years.   As part of the corporate restructure, Scynexis’ chief commercial officer position is being eliminated, meaning Christine Coyne, who has served in this leadership role for more than a year, will leave the company.  Meanwhile, former Athersys CFO Ivor Macleod will join as Scynexis’ chief financial officer starting Oct. 24. Release New face of Mirror Biologics: Former Luzsana leader Scott Filosi tapped as CEO   Mirror Biologics Mirror Biologics has tapped seasoned exec Scott Filosi to be the new face of the company as it gears up to become a commercial business.   Starting Nov. 15, Filosi will take the reins from interim CEO and founder Dr. Michael Har-Noy, who took up the temporary post after former interim CEO Adi Raviv departed in February.   In his new role, Filosi will oversee Mirror as it looks to commercialize its lead product, dubbed AlloStim, an "off-the-shelf," non-genetically manipulated, disease agnostic immunotherapy.  Filosi has years of market access and drug launch experience across multiple therapeutic areas, serving in numerous senior leadership roles at Merck KGaA, UCB Pharma, Boehringer Ingelheim and Johnson & Johnson.  Most recently, Filosi was founding CEO of Luzsana Biotechnology, a spinout from Jiangsu Hengrui Pharmaceutical, one of Asia’s largest pharmas. There, Filosi led the development of several oncology programs and aimed to “quantifiably reduce costs” of medicines.  Mirror’s mission runs certain parallels with Luzsana’s, driven by the goal to provide patients with non-toxic, affordable and widely accessible immunotherapies. Release > Former Biogen finance leader John Applegate is joining Verge Genomics as chief financial officer. After more than 14 years at Biogen, Applegate was most recently at Valo Health. Release > AstraZeneca’s rare disease business arm Alexion has appointed Scott Weintraub to serve as SVP and head of U.S. commercial operations, a company spokesperson told Fierce Biotech via email. Weintraub first joined Alexion in 2019, most recently serving as the company’s VP and head of global commercial strategy. > Lyn Baranowski is taking on her first chief executive role, joining pulmonary disease-focused Avalyn Pharma. Prior to this, she was chief operating officer at Altavant Sciences. Release > Bristol Myers Squibb alum Robert Petit has been tapped to lead early clinical development at Orionis Biosciences. Since leaving BMS in 2010, Petit has held a number of roles in biotech, including chief scientific officer at Advaxis. Release  > Flagship-founded Alltrna is appointing Caroline Kӧhrer, Ph.D., as VP of discovery platform. She won’t be moving far, bouncing over from Moderna, another Flagship company, where she was director of RNA science. Release > Some three months after temporarily taking the role of chief medical officer, Fulcrum Therapeutics R&D lead Judith Dunn, Ph.D., is resigning. But she’s not bolting out of the door, staying on in a consulting role until January 3, 2023. Disclosure > Senda Biosciences has a couple of new additions to its leadership team, naming Lori Rudolph-Owen, Ph.D., as chief operating officer and Barbara Bispham as SVP and general counsel. The company is two months removed from closing a $123 million financing round. Release > Ashvattha Therapeutics has tapped Steve Maricich, M.D., Ph.D., to serve as chief medical officer as the biotech prepares to launch clinical trials next year. Maricich joins Ashvattha from Calibr and Scripps BioVentures, where he also served as chief medical officer. Release > Cancer immunotherapy company Abalos Therapeutics has chosen Thomas Bogenrieder, M.D., P.h.D., to take up the role as chief medical officer. Bogenrieder previously served as chief clinical officer for Amal Therapeutics and has held leadership roles at Evaxion Biotech, Boehringer Ingelheim and GSK. Release > David Hollander, M.D., is joining Revance Therapeutics as chief medical officer. Hollander joins the commercial-stage biotech from Aerie Pharmaceuticals, where he served as head of R&D. Release > Belgium biotech Bioxodes has appointed a new CEO as the company prepares to launch a phase 2a trial for patients with intracerebral hemorrhage. Marc Dechamps will take over the role from company founder Edmond Godfroid, who will assume the role of chief operating officer alongside his existing responsibilities as chief scientific officer. Dechamps is a biologist with more than 30 years of experience, including working at GSK and ViiV Healthcare. Release > Ankyra Therapeutics has tapped Joseph Elassal, M.D., to fill its chief medical officer position after former CMO Howard Kaufman, M.D., transitioned to helm the biotech as president and CEO. Previously, Elassal has held roles at Regeneron, Pfizer and PhRMA, among others. Release