Quantum Genomics SA

▲5月30-31日 第八届广州生物医药创新者峰会 扫码立即报名 注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。近40年首例！FDA批准新机制降压药Aprocitentan上市2024年3月20日，美国食品药品监督管理局（FDA）批准由瑞士Idorsia制药公司与强生联合研发的降压新药阿普昔腾坦（aprocitentan，商品名Tryvio）上市。FDA批准该药与其他降压药物联合，用于治疗难治性高血压。该药的获批，引起业内人士的广泛关注，原因主要有两方面：（1）阿普昔腾坦通过抑制内皮素（ET）-1与ETA和ETB两种亚型受体的结合而降低血压，是FDA近40年来第一个批准的全新降压机制的药物；（2）可以有效地治疗血压控制不佳的难治性高血压。市场潜力巨大！人口老龄化驱动高血压用药需求飙升高血压是最常见的慢性非传染性疾病之一，是脑卒中、冠心病、心力衰竭、慢性肾病等多种疾病的危险因素。流行病学调查显示，截止到2012年，我国年龄≥18岁的成人高血压发病率升高至25.2%。随着社会老龄人口的增多，高血压发病率逐年升高，但高血压控制率仍然很低。高血压病的发生发展与交感神经系统亢进、肾素-血管紧张素-醛固酮系统（RAAS）激活、肾脏排泄功能障碍、血管内皮损害、胰岛素抵抗及家族遗传等多种因素相关。目前，高血压的治疗仍以药物治疗为主，已上市的抗高血压药物主要包括利尿剂、钙离子通道阻滞剂（CCB）、β 受体阻滞剂、血管紧张素转换酶抑制剂（ACEI）和血管紧张素Ⅱ受体阻断剂（ARB）等。根据药融云数据统计，2015-2019年国内高血压市场持续扩容，至2019年达到690.92亿元（未统计中药），2020年以后，受疫情、集采等因素影响，整体市场有一定萎缩，但销量基本稳中有升。从细分市场来看，钙通道阻断剂、血管紧张素Ⅱ拮抗剂为市场份额较高品类，2022年市场占比分别达到40.13%、31.03%，β受体阻断剂近年来市场份额逐步提升。未来，随着人口老龄化加剧、生活习惯进一步改变等因素影响下，以高血压为代表的慢病患者人数不断增加，抗高血压用药需求仍将稳步增长。2015-2022年国内抗高血压药物销售额数据来源：药融云全产业链数据库&药融咨询整理2015-2022年国内抗高血压药物主要品类市场占比数据来源：药融云全产业链数据库&药融咨询整理 新机制降压药涌现，高血压治疗领域迎来曙光目前高血压的治疗仍以药物治疗为主，足剂量、长效制剂、个体化、联合应用抗高血压药物是治疗高血压的基本原则。但我国高血压患者血压达标率不高，与单药治疗疗效欠佳、药物的可耐受性及患者依从性差等因素有关，因此研发新型和新作用靶点的降压药对提高血压达标率具有重要的临床意义。目前，抗高血压药物的研发重点在于对传统降压药物的改进（如新型双通道阻断型钙通道阻滞剂、直接肾素抑制剂、双重内皮素受体拮抗剂、内皮素A型受体/血管紧张素受体亚型1拮抗剂）以及探索新作用靶点的降压药物（如新型氨基肽酶A抑制剂、钠钾离子通道转换酶抑制剂、利钠肽受体激动剂、多巴胺β-羟化酶抑制剂、膜金属内肽酶抑制剂、可溶性鸟苷酸环化酶刺激剂）等方面。高血压领域主流在研作用机制及代表药物数据来源：药融云全产业链数据库&药融咨询整理根据药融云数据统计，目前全球共有1176款高血压相关研发药物（按高血压适应症统计，不包含上市阶段），其中研发活跃状态药物共计310款，占比达26.36 % ，IND及以上阶段药物112款，占比达9.52% ，值得一提的是，处于研究终止、研究暂停、无后续进展报道、撤市等非活跃状态的药物共866款，占比高达73.64%。然而，近年来，随着高血压基础研究和治疗等方面的不断深入，国内外诸多对新型降压药物靶点的研究已取得较大进展，并陆续有用于高血压治疗的新药获批，为该领域的发展带来新的曙光。因篇幅有限，本文总结和归纳了几种值得关注的新作用机制的药物研发进展，供参考。 01ETA/ETB双重内皮素受体拮抗剂 内皮素（ET）是由 21 个氨基酸组成的血管收缩肽，有三种类型，即 ET-1、ET-2、ET-3，作用于血管平滑肌受体ETA 和 ETB，这两种受体具有非常明显的相互拮抗效应。ET-1 作用于 ETA 既能引起人和哺乳动物体内强烈的血管收缩，也能激活 RAAS，刺激儿茶酚胺释放。ETA 激活后会诱导血管收缩，而ETB 激活后能够激发内皮舒张因子释放，产生血管舒张效应，抵消ETA的缩血管作用。目前关于ET受体拮抗剂（ERAs）相关研究显示，ERAs可以分为两种类型，即选择性ERAs和非选择性 ERAs。目前临床已在使用的内皮素受体拮抗剂包括波生坦（非选择性 ERA）、安立生坦（选择性ERA）、马昔腾坦（选择性ERA），以上药物主要用于治疗肺动脉高压，而并非高血压。单纯阻断ETA可能导致ETB受体的过度刺激，引起非选择性血管舒张、血管通透性增加、外周水肿加重以及血浆加压素和醛固酮水平升高。研究显示，与安慰剂相比，ETA阻断药物能够显著降低收缩压和舒张压，但水肿和液体潴留风险也显著增加。因此，研究者把目光转向选择性靶向ETB受体而非ETA受体的药物。前文所述的Aprocitentan 是 Quantum Genomics SA 公司研发的新型口服 ETA/ETB 双重受体拮抗剂，其对ETB受体的亲和力高出16倍，半衰期长达44 h，既不会干扰胆盐分泌，也不具有肝毒性，为难治性高血压患者的降压治疗提供了新思路。02直接肾素抑制剂 RAAS 在高血压的发生发展中具有重要作用，肾球囊细胞分泌的肾素可将肝脏合成的血管紧张素原转变为血管紧张素Ⅰ（AngⅠ），后者在血管紧张素转化酶（ACE）的活化作用下转化为血管紧张素Ⅱ（Ang Ⅱ）。Ang Ⅱ主要作用于血管紧张素受体亚型1（AT1），具有促进血管收缩、水钠潴留、增强交感系统的活性、导致血压上升的作用。直接肾素抑制剂能够直接抑制肾素的产生，降低体内Ang Ⅱ浓度，拮抗Ang Ⅱ的升压作用。阿利吉伦是目前惟一上市的直接肾素抑制剂，其单独使用或与其他药物联用治疗高血压均安全有效。但是，阿利吉伦的口服生物利用度相对较低，合成途径较长，在临床实践中患者可能会出现严重的不良反应。中央研究院、上海医药控股有限公司（中国）和三菱田边制药公司（日本）联合研发得到新一代的直接肾素抑制剂 SPH3127，于2023年5月达到III期临床试验确证性研究（SPH3127-301第二阶段）方案预设的主要研究终点指标。研究共入组828例患者，实验方案为SPH3127片100mg/次，口服，每日一次，连续用药12周。试验结果显示，SPH3127可降低原发性高血压患者msDBP，安全有效，提示SPH312片可为原发性高血压患者提供一种新的治疗途径和更丰富的治疗组合。此外，研发团队还积极拓展SPH3127新适应症，其中糖尿病肾病适应症正在中国开展Ⅱ期临床试验，溃疡性结肠炎适应症也正在中国、美国开展Ⅱ期临床试验。 03钠钾离子通道转换酶抑制剂 在肾小管的基底外侧，Na+-K+泵是肾脏钠重吸收的驱动器，改变Na+-K+泵功能能够改变全身血容量，进而引发高血压。因此，肾小管Na+-K+泵是潜在的治疗高血压的新靶点。研究表明，在人类和大鼠中存在两种影响肾脏 Na+-K+泵功能的因子，即盐调节激素内源性哇巴因和突变的细胞骨架蛋白 α-内收蛋白。以上两种因子通过异常激活Na+-K+离子泵，促进水钠潴留，引发高血压。因此，针对这两种作用靶点开发的药物能够抵抗哇巴因和突变型α内收蛋白对Na+-K+泵功能的影响。Rostafuroxin 是一种安全有效的洋地黄毒苷衍生物，目前处于临床Ⅱ期，李氏大药厂已于今年1月获得在大中华地区开发和商业化Rostafuroxin的许可。Rostafuroxin作用于Src-SH2域，能够选择性抑制Src活化，通过抑制相关信号通路来抑制肾小管对Na+的重吸收，从而发挥降低血压作用。PEARL-HT临床试验结果显示，与安慰剂相比，Rostafuroxin 对中国受试者收缩压的影响不明显；因此 Rostafuroxin可能用于指导白种人原发性高血压的药物治疗，但针对中国原发性高血压患者的靶向治疗药物仍需要更进一步的研究。 04新型氨基肽酶A（APA）抑制剂 APA和氨基肽酶 N（APN）是两种膜结合的锌金属蛋白酶，分别参与脑Ang Ⅱ和Ang Ⅲ的代谢，APA从 Ang Ⅱ切割 N 末端天冬氨酸形成 Ang Ⅲ，而 APN从 Ang Ⅲ切割 N 末端精氨酸形成血管紧张素Ⅳ（Ang Ⅳ）。Ang Ⅱ和 Ang Ⅲ与脑 Ang Ⅱ受体的亲和力相似，均可通过激活交感神经活性、在孤束核水平抑制压力反射，以及增加血液中精氨酸加压素浓度而引起血压升高。在动物实验中，脑室注射选择性 APA 抑制剂 EC33 能够引起血压下降，提示EC33 可阻滞 Ang Ⅲ的压力反射，相较于脑中 AngⅡ，Ang Ⅲ的升压作用更强。新型氨基肽酶 A 抑制剂 Firibastat 是美国 Quantum Genomics 制药公司开发的一种首创降压药，该药物通过在大脑中递送EC33产物，特异地抑制氨基肽酶 A，从而减少 Ang Ⅲ的产生，起到降低血压作用。研究表明，它可以通过降低全身加压素水平、降低交感神经张力和刺激压力反射来降低血压。一项多中心、开放标签2b期研究纳入256名原发性高血压患者，证明Firibastat是有效的。然而，在一项多中心（11个国家，75家中心）、随机、双盲、安慰剂对照、Ⅲ期研究（FRESH试验）中，未能证实Firibastat能够有效降低难治性高血压患者AOBP结果；所有亚组与次要终点的结果是一致的；Firibastat组患者耐受性良好，最常见的不良反应为皮肤反应，发生率为5.1%。结语随着老龄化的加剧，我国高血压的发病率将越来越高，国家已通过带量采购降价、加快纳入医保目录的速度及鼓励新药研发等举措提高高血压药物的可及性。总体来看，近年开展的带量采购对抗高血压仿制药市场影响巨大，而目前该领域仍存在未满足临床需求，Aprocitentan 的成功获批，标志着高血压治疗领域新药研发曙光初现，未来可期。版权声明：本文转自药融云，如不希望被转载的媒体或个人可与我们联系，我们将立即删除 活动推荐  5月 • 第八届大湾区生物医药创新者峰会  关键词：  小分子，XDC，多肽及GLP-1热点话题，80+行业专家（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

Biotech裁员已不仅仅局限在“可有可无”的基层工作人员和那百分之几的数字代号，而是直接传递至了举足轻重的高管层面。这年头，连CEO都开始“高危”了。6月伊始，一家纳斯达克上市的RNA药物公司Oncorus突然出现在大家视野。背后原因令人唏嘘，该公司再次宣布裁撤55名员工，其中包括CEO、COO、CMO。不到一年时间，这已是该公司第二次宣布裁员。早在7个月前，Oncorus宣布终止了某款候选药物的后续研发，同时裁员20%，彼时那场裁员节流仍没能让它撑过2023年。实际上，今年来Biotech公司C(X)O级别的高管被裁现象愈发常见，寒冬中的那场裁员“宿醉”，似乎仍在继续。C“X”O秒变高危？“钱荒”泥淖仍在继续，传递到Biotech身上，最直接的表现便是裁员砍管线以节流。仅2023年来看，截至目前，据外媒Fierce Biotech裁员数据跟踪，涉及82家美国制药公司裁员。其中2月最多，涉及24家Biotech，相当于每个工作日都会传出一家Biotech裁员消息。不仅仅是裁员，部分Biotech没能熬过寒冬，甚至选择了直接“关门”。如小型药物发现生物技术公司Vyant Bio和专注于基因治疗的Coda Biotheraputics等公司。裁员已不仅仅只局限在“可有可无”的基层工作人员，也不再只是那百分之几的数字代号，而是直接传递至举足轻重的高管层面，CEO、COO、CMO、CSO出现的频率越来越高。寒冬以来，Biotech的高管们也自身难保。据E药经理人不完全统计，今年以来，超10家Biotech裁撤了自家CEO。一个多月前，“数字疗法第一股”Pear Therapeutics于4月宣布申请破产保护，裁撤了包括CEO在内的几乎所有员工（共170人，占92%），仅留下15人在法院监督下，寻找并完成接下来的流程。“先驱成先烈”一时令人哗然。同月，Talaris Therapeutics在一份美国证券交易委员会文件中透露，正在解雇80名员工，约占公司员工的95%。此次裁员的名单中包括首席执行官Scott Requadt、首席医疗官Nancy Krieger, M.D.、首席技术官Michael Zdanowski和首席人力资源官Andrew Farnsworth。不过，该公司表示，首席财务官Mary Kay Fenton将被保留，同时Talaris Therapeutics将继续寻找“战略交易”，以避免诉诸清算。更早些，继裁减40%并放弃候选管线的几个月后，Neoleukin Therapeutics裁撤了包括CEO在内的70%员工，并寻找战略替代方案。同样寻找战略替代方案的还有处于临床阶段的生物制药公司AMT，解雇57%员工，同时Tahir Mahmood离任首席执行官一职，总裁兼首席运营官Shawn Cross暂时接任。CEO出局的还有Elevation Oncology、小型药物发现生物技术公司Vyant Bio、Quantum Genomics等。在暂停实体肿瘤疗法seribantumab的开发后，Elevation Oncology于今年1月宣布裁员30%，包括CEO Shawn Leland；Vyant Bio也分别与首席执行官约翰·罗伯茨（John Roberts）、首席科学官小罗伯特·弗雷莫（Robert Fremeau Jr.）告别；Quantum Genomics裁减了数量不详的员工，包括CEO；在进行重大改革后，Quantum创始人兼总裁莱昂内尔·塞加德（Lionel Ségard）已被罢免，将由首席执行官让-菲利普·米隆（Jean-Philippe Milon）取代……再三挣扎后，许多生物技术公司不得不做出与Oncorus们类似的决定，Vyant Bio、Editas、Elevation Oncology等公司亦裁掉了首席执行官、首席科学官等重要高管。而当公司产品线重心调整时， CSO及研发部门无奈遭殃。1月，基因编辑公司Editas宣布裁员20%，包括首席科学官Mark Shearman。与此同时，重新规划公司产品线重心，暂停多个核心管线的研发。Spero Therapeutics裁员75%，波及CMO和COO。本次裁员将让Spero或有足够的现金储备坚持到2023年底。“裁员、裁员、裁员，今年听到这两个字的次数比我过去五年时间里听到的都多。”一位业内人士向E药经理人感慨道。有些Biotech三个月内甚至进行了3轮以上的裁员，而裁员比例在50%至95%区间的，比比皆是。寒冬以来的这场“宿醉”，似乎远未结束，涉身其中的高管们也越来越多。震荡之期，“饭碗”不好保至今，美国Biotech行业发展史上主要经历了5次显著震荡期，上一次是2015-2017年的价值回调，而从2021年至今，Biotech的重创并没有好，甚至还在恶化。不妨做个对比。以外媒Fierce Biotech统计的数据来看，2022年上半年，平均每3天有一家Biotech公司在裁员。但那段难熬的市场低迷时期却持续到了今天，且愈发恶劣。2023年前5个月时间，约80家Biotech宣布裁员，平均不到2天的时间内便有一家Biotech与员工，甚至CEO、CMO、COO等高管含泪说“拜拜”。不少Biotech的员工薪资也是大幅缩水。此前，BioSpace发布的美国生物制药行业的薪酬情况显示，2023年生物科技行业的薪资增长速度，显著低于往年，但在2022年，生物制药行业的薪酬远高于整体，甚至增速逐年递增。有雄厚现金流的跨国大药企大肆裁员，更多是针对销售、营销团队，抑或是减少内部研发贡献，依赖于外部创新，或在旗下某一业务板块利润不及预期、生产效率低下的情况下，关工厂，裁掉生产人员，精简组织，这一切都是为了去赢取未来。但是Biotech不一样，对于一些初创药企来说，它们活在震荡期中，在讲不好未来的同时，也无法确保现在的周全，生存成了大问题，直接宣布进入破产程序的Biotech不止一家两家。经济层面上，全球经济萧条，新冠概念温度骤降，行业大幅下行；政策层面上，地缘政治风险加剧，全球Biotech公司受创；技术层面上，过去不久的新冠疫情、疗效和安全性标准促使Biotech企业临床开发成功率下降到历史低点。而在裁员潮数据背后，仍可以总结出一些共有的裁员原因，主要有以下几种：候选药物临床试验失败，数据不佳；与合作伙伴终止在某一领域早期发现和临床前研究工作；聚焦某些管线，研发重点转移；裁员是公司重组的一部分，或去适应不断变化的投资组合需求；破产倒计时，正寻求出售其资产。当然，归根结底，最主要的原因还是财务问题。在全球范围内的市场持续动荡的情况下，投资者的谨慎让越来越多的Biotech开始担心自己的资金链，而改善自身财务困局、节约资金、降低成本和优化效率最直观的办法便是裁员。减少人力支出即可快速降低运营成本，缓解已经或即将陷入的现金储备减少带来的财务困境。宣布裁员的Biotech中，基因和细胞疗法公司首当其冲。有外媒统计，仅在今年头三个月里，裁员的新疗法Biotech中约有三分之一为基因和细胞疗法企业。作为生物医药创新高地的美国，生物技术公司的生存仍然举步维艰。总体来看，裁员、破产现在对于Biotech来说已成常态，而大药企也正在梳理自身管线，等到合适的时机，两种高效的资产有可能走进整合模式。有券商估计，大型制药公司手头有2000亿美元的现金，而中小型生物技术公司的总市值为5000亿美元，占整个市场的40%。大型制药公司完全有能力可以帮助整合生物技术行业。普华永道也曾预测：“战略调整和投资组合管理将持续到2023年。准备充分且积极主动的管理团队愿意考虑收购和资产剥离，也将最有能力提供丰厚的回报。”此前，三一创新投资管理合伙人尹正向E药经理人表示，MNC之所以可以以BD形式来获得资产，且愿意给出较高的价钱，很重要的原因是他们具备全球的商业化网络，且有雄厚的资金实力。但是，这对于国内部分的Pharma来说，它们或没有全球化的商业网络，本身资金实力或也决定了不大可能在首付上愿意给出一个“天价”。当然，2023年Biotech裁员虽屡见不鲜，但还是要看到向好的一面。从另一个角度看，人员的流动给新兴技术领域能够提供更多人才资源，同时也让人员更有机会接触那些新兴技术领域。因此裁员对于公司和个人来说，未必是一件坏事。登记邮箱信息订阅E药经理人信息服务扫描二维码精彩推荐CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化 ｜ 猎药人系列专题启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖 ｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 |  荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药 ｜再鼎医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

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.  Roivant Sciences founder ditches company board for White House bid Roivant Sciences D.C.-vant? Washington-vant? Commander-in-vant? The names don’t particularly roll off the tongue, but they’re reflective of the new grandiose ambition of Roivant founder Vivek Ramaswamy. The entrepreneur-turned-anti-woke-pariah announced a formal run this week for the White House, becoming the third Republican candidate to enter the field. As a part of the decision, Ramaswamy departed from Roivant’s board.  His pursuit of arguably the most significant political office in the world comes less than 10 years after Ramaswamy launched Roivant. The company has since spun out more than 20 “vant” subsidiaries, which essentially act as small spinouts focused on the development of a specific drug or disease area. Existing vants include dermatology-focused Dermavant and Immunovant, which is tailored to … you probably guessed it.  But you won’t hear much about Roivant in Ramaswamy’s launch video, which is focused squarely on what he bemoans is a nationwide “identity crisis” and the “woke left.” It’s much of the same views that Ramaswamy has championed for years as he’s made himself one of the key figures fighting against the intersection of social politics and corporate life. He won’t be the only former entrepreneur in the race, however, taking on the current polling favorite and former President Donald Trump. Fierce Biotech Top FDA oncology deputy departs for new biotech Food and Drug Administration  Julia Beaver, M.D., has departed the FDA to take on a new role as senior vice president of clinical development at Treeline Biosciences. Beaver was previously chief medical officer of the FDA’s Oncology Center for Excellence and acting deputy director of the Office of Oncologic Diseases. Her departure was confirmed by the agency.  Beaver’s move marks her first foray into industry after working for nine and a half years at the FDA following nine years at Johns Hopkins. The cancer professor and regulator now heads up clinical development at one of the buzziest biotechs in the business. Treeline has raised almost half a billion dollars including a $261 million series A.  Ironically, the CEO of Treeline is a former regulator himself. Josh Bilenker, M.D., was a medical officer at the agency before launching Loxo Oncology in 2013, which was ultimately sold to Eli Lilly for $8 billion in 2019. According to Bilenker’s LinkedIn, he started working on Treeline in April 2021. LinkedIn   Medidata names new top executives  Medidata  Medidata announced that it had tapped Pascal Daloz to be its new chief executive, finding a permanent replacement after an 18-month search. Daloz, who was influential in Dassault Systèmes acquisition of Medidata in 2019, replaces co-CEOs Rama Kondru and Sastry Chilukuri. The company also announced it had tapped former chief commercial officer Michael Pray to be chief operating officer.   The two major hires come a year and a half after Kondru and Chilukuri were named interim co-CEOs of the life science software provider. Just weeks later, Medidata’s co-founder, Glen de Vries, died in a plane crash in New Jersey. De Vries launched the company in 1999 and sold it to Dassault in 2019. And his love of aviation was emblematic in the fact that he was one of a handful of people to join Amazon founder Jeff Bezos on a Blue Origins flight earlier in 2021.  In its hiring announcement, Medidata says Pray will be responsible for day-to-day operations at the company and will report directly to Daloz. Fierce Biotech > Moderna’s Juan Andres will be retiring in May after working at the Big Pharma for more than six years. Andres is currently president of strategic partnerships and enterprise expansion for the company, and has also served as chief technical operations and quality officer. Prior to Moderna, Andres held leadership roles at Eli Lilly and Novartis. Release  > Having already drastically reduced head count, ObsEva has now turned its sights on the company’s U.S.-based leadership. The women’s-health focused biotech waved goodbye to CEO Brian O’Callaghan, Chief Commercial Officer Clive Bertram, Chief Clinical Officer Brandi Howard and Chief Transformation Officer Luigi Marro. Clancy and O’Callaghan are among five board members who will be stepping down. The biotech has already began a search for a CEO who will be based at the company’s home of Switzerland. Fierce Biotech > CymaBay Therapeutics Chief Medical Officer Dennis Kim, M.D., resigned Feb. 20, effective immediately. Release > Precision BioSciences is shaking up its leadership team, promoting VP of CMC Neil Leatherbury to SVP, head of CMC. Meanwhile, Co-Founder and Chief Scientific Officer Derek Jantz, Ph.D., has announced his intentions to eventually step away from his current day-to-day responsibilities and will instead take on the role of chief science advisor. Additionally, Co-Founder and Chief Research Officer Jeff Smith, Ph.D., will tack on leadership of the Precision's joint steering committees with Eli Lilly and Novartis and serve as head scientific lead for potential new business development partners. Release > Arthur Levin, Ph.D., is transitioning out of his role as Avidity’s chief scientific officer to the board of directors and the role of distinguished scientist and strategic leader. Levin is a founding member of Avidity, and his spot as CSO will be taken up by Chief Technical Officer Michael Flanagan, Ph.D., who will remain in his current role as well. Release   > NextPoint Therapeutics has appointed Leena Gandhi, M.D., Ph.D., to serve as chief medical officer and oversee development of its precision immuno-oncology programs. Gandhi previously worked at the Dana-Farber Cancer Institute, where she was director of the Center for Cancer Therapeutic Innovation, and has also previously served as Eli Lilly’s VP of immuno-oncology development. Release > After ending all cardiology work, Quantum Genomics is reorganizing its board of directors, restructuring staff and conducting another strategic review. Frédéric Duchesne resigned from his role as independent administrator, while founder and President Lionel Ségard has been ousted and will be replaced with CEO Jean-Philippe Milon. Fierce Biotech > Chester Wong is jumping from Big Pharma to biotech, exiting his role as director of business development for Amgen to become Cartography Biosciences’ VP and head of business development. Wong will help the biotech, which emerged last summer, form key industry relationships that advance its pipeline of next-gen cancer immunotherapies. Release    > After a business review, Graphite Bio is writing off a sickle cell therapy and cutting half its staff—including two executives. Chief Business Officer Philip Gutry and Chief Scientific Officer Jane Grogan, Ph.D., are slated to leave the company at the end of the second quarter. Fierce Biotech > Transcend Therapeutics has emerged with a $40 million series A and several C-suite leaders. The biotech working to develop meds for neuropsychiatric diseases is led by co-founder and CEO Blake Mandell, who has spent most of his career working in venture capital. Fellow co-founder Kevin Ryan, who is also the founder and CEO AlleyCorp, will serve as chair for Transcend, while third co-founder Ben Kelmendi, M.D., will hold the spot as chief scientific adviser. Meanwhile, Martin Stogniew, Ph.D., who has led development at six biotech startups, will take on the role of chief development officer. In the spot of SVP of clinical development is Amanda Jones, who most recently led clinical development at Axsome Therapeutics. Release   > Impel Pharmaceuticals is reducing its head count by 16% to save cash, with Chief Medical Officer Stephen Shrewsbury, M.D., also heading out the door at the end of March. Fierce Biotech   > Alongside the launch of a new wet-dry lab, Relation Therapeutics has tapped Edith Hessel, Ph.D., to fill its chief scientific officer spot. Hessel is a former GSK R&D exec and helped build out the Big Pharma’s Refractory Respiratory Inflammation Discovery Performance Unit. Release  > Starting March 1, Taiwan-based BRIM Biotechnology will have a new CEO at the helm. Dr. Wen-Chyi Shyu is taking the reins from Dr. Haishan Jang, Brim’s CEO and chair. Shyu has clocked in experience for many Big Pharmas, including Bristol Myers Squibb and Takeda, and will help the biotech expand internationally. Meanwhile, globally known entrepreneur Andrew Lin will take over as company chair. Release > Kate Broderick will become Maravai Life Sciences’ chief innovation officer of the newly created office of science and innovation. Broderick joined Maravai’s TriLink Biotechnologies in July 2022 as SVP of R&D and, before that, spent 15 years at Inovio Pharmaceuticals. Release  > AI-driven Genomenon has tapped John Battles to serve as its VP of engineering. Battles has more than 25 years of experience in the field, with past roles at Genomind and Q2 Solutions, among others. Release