Canakinumab

Mina Kim appointed Chief Executive Officer and to Board of Directors ACELYRIN Founder Shao-Lee Lin, M.D., Ph.D., steps down as Chief Executive Officer Shephard (Shep) Mpofu, M.D., MRCP, FRCP named Chief Medical Officer, Gil Labrucherie, the company’s Chief Financial Officer, additionally named Chief Business Officer, and Sanam Pangali named Chief Legal Officer and Head of People LOS ANGELES, May 09, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that ACELYRIN’s founder Shao-Lee Lin, M.D., Ph.D. has stepped down as Chief Executive Officer and that Mina Kim, chief legal and administrative officer at ACELYRIN, has been appointed Chief Executive Officer and to the company’s Board of Directors (the “Board”). Ms. Kim brings more than 20 years of operational and leadership experience across a range of industries including synthetic biology, immunotherapy, renewable energy, and aviation. Ms. Kim played a pivotal role in ACELYRIN’s initial public offering and has served as ACELYRIN’s Chief Legal and Administrative Officer since November 2022. Prior to that, she served as Chief Legal Officer and Head of Corporate Development at Zymergen, Inc., where she led the company’s corporate strategy and business development teams and built its legal team. She also oversaw Zymergen’s 2021 IPO process and the company’s eventual sale to Ginkgo Bioworks. Bruce Cozadd, chair of the ACELYRIN Board of Directors, said, “ACELYRIN is at an inflection point having recently announced early but exciting data for lonigutamab in thyroid eye disease and a positive late-stage trial for izokibep in psoriatic arthritis. The Board and Shao-Lee believe now is the right time to make these changes as we focus on prioritizing our portfolio to enable future success. Mina’s significant experience overseeing corporate strategy and corporate development, coupled with her knowledge of ACELYRIN’s pipeline and operations, make her the right person to lead ACELYRIN into its next chapter. The Board is confident that under Mina’s leadership ACELYRIN will realize its potential, driving value for shareholders and transforming patients’ lives.” “I am honored to serve as the next Chief Executive Officer of ACELYRIN,” said Ms. Kim. “With encouraging data across our pipeline, we are continuing to advance our core mission of making a meaningful difference for patients. At the same time, we remain committed to reviewing our strategy, making disciplined decisions about portfolio prioritization and being responsible stewards of capital to best position our assets for successful development and potential commercialization in the future. I am excited to continue working with our employees and partners in this new capacity.” Cozadd continued, “On behalf of the Board, I would like to recognize Shao-Lee for her vision in leading ACELYRIN from inception through to becoming a well-capitalized public company. She has built a talented and accomplished team, and created a promising portfolio of clinical stage programs, each with the potential to fulfill ACELYRIN’s mission of delivering meaningful new medicines for patients. We wish her all the best in the future.” “Since the founding of ACELYRIN, we have been singularly focused on making a meaningful impact on patients’ lives by pursuing innovative approaches to speed the development of life-changing therapies,” said Dr. Lin. “Building and leading ACELYRIN to this moment in its history has been a tremendous honor and privilege. It is time for the next stage of evolution for the company. I wish the team every success in the continued pursuit of our mission to make meaningful new medicines for patients.” In addition to Ms. Kim’s appointment, Shephard (Shep) Mpofu, M.D., MRCP, FRCP, who most recently served as ACELYRIN’s Senior Vice President of Development, has been promoted to the role of Chief Medical Officer, Gil Labrucherie, who serves as ACELYRIN’s Chief Financial Officer, has been named Chief Business Officer in addition to Chief Financial Officer, and Sanam Pangali, who most recently served as ACELYRIN’s Senior Vice President, Corporate Legal, has been promoted to Chief Legal Officer and Head of People. Business Update and Key Upcoming Milestones In a separate press release ACELYRIN provided an update on various corporate milestones and announced that it will forego hosting the previously scheduled Q1 2024 earnings call. The company will file the related quarterly report on Form 10-Q no later than May 14, 2024. The press release can be found on the investor relations section of the company’s website. About Mina KimMina Kim has served as the Chief Legal and Administrative Officer of ACELYRIN, INC. since 2022. From 2020 to 2022, Ms. Kim was the Chief Legal Officer and Head of Corporate Development at Zymergen, Inc., where she oversaw corporate strategy, business development, corporate & SEC reporting, intellectual property, litigation and employment, compliance, regulatory, public policy, and sustainability. She led Zymergen’s 2021 IPO process and later sale to Ginkgo Bioworks. Prior to Zymergen, Ms. Kim served as Senior Vice President of Corporate Strategy and General Counsel at Atara Biotherapeutics. Before Atara, Ms. Kim was General Counsel at Sunrun where she led the 2015 IPO. Earlier in her career she was Vice President, Legal at BBAM, LLC, General Counsel of Fly Leasing, Assistant General Counsel at Williams-Sonoma, and an Associate at the law firm Davis Polk & Wardwell. She holds a JD from Harvard Law School and a BA in History from Dartmouth College. About Shep MpofuShep Mpofu has served as Senior Vice President, Development and Translational Sciences of ACELYRIN, INC. since October 2023. Prior to ACELYRIN he spent nearly 20 years at Novartis AG, where he most recently served as Chief Medical Officer for its Gene Therapy Franchise. At Novartis he held positions of increasing responsibility in the immunology, rheumatology and dermatology franchises, which culminated with global leadership of clinical development for canakinumab and secukinumab. He is a UK General Medical Council Board-certified rheumatologist, who previously practiced at several institutions in the UK. He is a Fellow of the Royal College of Physicians UK, and he obtained his MB.Ch.B (Bachelor of Medicine and Bachelor of Surgery degrees) from the Godfrey Huggins School of Medicine at the University of Zimbabwe. About Gil LabrucherieGil has served as the Chief Financial Officer of ACELYRIN, INC. since 2022. He was previously Chief Financial Officer and Chief Operating Officer of Nektar Therapeutics where he led a team of more than 150 professionals in financial accounting and public reporting, business and strategic planning, corporate legal, intellectual property, government affairs, information technology and supply chain management. Prior to that he was the Senior Vice President and General Counsel at Nektar, Vice President of Corporate Development at E2open, Inc. and Senior Director of Corporate Development at AltaVista Company. He began his career as corporate counsel at Wilson Sonsini Goodrich & Rosati. Gil holds a JD from the University of California Berkeley School of Law and a BA from the University of California Davis. He is also a CFA charterholder. About Sanam PangaliSanam Pangali has served as Senior Vice President, Corporate Legal of ACELYRIN, INC. since October 2023 and previously served as Vice President, Corporate Legal. Prior to joining ACELYRIN in 2022, she served as General Counsel, Vice President and Corporate Secretary at Snapdocs, Inc., a technology company in the mortgage lending space, from 2020 to 2021. Before that, she served as Senior Director & Associate General Counsel at Principia Biopharma Inc. through its September 2020 acquisition by Sanofi. Earlier in her career, she led the corporate and commercial contracting legal functions at Sunrun Inc., from 2016 to 2019 and prior to that was Director & Assistant General Counsel at affiliates TerraForm Power and SunEdison Inc. from 2013 to 2016, spanning mergers and acquisitions, project finance and development. Ms. Pangali began her legal career as a Senior Associate at Morrison & Foerster LLP for six years working in the firm’s Business and Finance practice groups, advising clients in capital markets, venture capital, mergers and acquisitions, project finance and corporate governance matters. She holds a JD from the University of Pennsylvania Carey Law School and a BA in Political Science, with a Minor in Economics, from the University of California, San Diego. About ACELYRIN, INC.ACELYRIN, INC. (Nasdaq: SLRN) is a Los Angeles area-based late-stage clinical biopharma company – with additional operations in the San Francisco Bay area – focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines. ACELYRIN has two programs in late-stage clinical development. Lonigutamab is a subcutaneously delivered monoclonal antibody targeting IGF-1R advancing into Phase 2b/3 development for the treatment of thyroid eye disease. Izokibep is a next generation inhibitor of IL-17A in Phase 2b/3 development for the treatment of psoriatic arthritis, hidradenitis suppurativa and uveitis. For more information about ACELYRIN, visit us at www.acelyrin.com or follow us on LinkedIn and X. Forward Looking StatementsThis press release contains forward-looking statements including, but not limited to, statements related to ACELYRIN’s focus on prioritizing its portfolio to ensure future success, driving value for shareholders and transforming patients’ lives; the therapeutic potential of ACELYRIN’s product candidates; future development and commercialization of ACELYRIN’s assets; ACELYRIN working to advance the development of lonigutamab and izokibep; and other statements that are not historical fact. These forward-looking statements are based on ACELYRIN’s current plans, objectives and projections, and are inherently subject to risks and uncertainties that may cause ACELYRIN’s actual results to materially differ from those anticipated in such forward-looking statements. Such risks and uncertainties include, without limitation, those associated with the successful completion of development and regulatory activities with respect to ACELYRIN’s product candidates; the timing and results of ACELYRIN’s clinical trials, including the risk that future clinical trial results could differ materially and adversely from prior clinical trial results or data; maintaining and defending intellectual property protection; delays or failures to secure adequate supply of its product candidates; the sufficiency of ACELYRIN’s cash resources; legal proceedings; and other risks and uncertainties affecting ACELYRIN including those described from time to time under the caption “Risk Factors” and elsewhere in ACELYRIN’s current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2023. Forward-looking statements contained in this press release are made as of this date, and ACELYRIN undertakes no duty to update such information except as required under applicable law. ACELYRIN, INC. Contact:Tyler MarciniakVice President of Investor Relations, Communications and Advocacyinvestors@acelyrin.commedia@acelyrin.com

点击蓝字关注我们本周，热点不少。首先是审评审批方面，国内外均有进展。来看国内，很值得关注的就是两个，君实生物特瑞普利单抗成为我国首个获批的肾癌免疫疗法以及首个罗普司亭生物类似药国内获批上市。再看国外，迪哲医药舒沃替尼再获FDA突破性疗法认定；其次是研发方面，多个药启动Ⅲ期临床，比如礼新医药启动了LM-302三线治疗CLDN18.2阳性胃或胃食管交界部腺癌（G/GEJ）的Ⅲ期临床试验；最后是交易及投融资方面，Vertex 49亿美元收购了Alpine。本周盘点包括审评审批、研发、交易及投融资三大板块，统计时间为4.7-4.12，包含31条信息。 审评审批NMPA上市批准1、4月7日，NMPA官网显示，罗氏的利妥昔单抗皮下注射液（商品名：MabTherasc）获批上市。利妥昔单抗为罗氏与渤健合作开发的一款CD20单克隆抗体，皮下注射液是罗氏利用Halozyme的Enhanze技术开发的一款剂型创新产品，于2014年3月在欧盟首次获批上市。2、4月7日，NMPA官网显示，君实生物的PD-1单克隆抗体特瑞普利单抗注射液新适应症获批，联合阿昔替尼一线治疗中高危不可切除或转移性肾细胞癌患者。特瑞普利单抗也成为我国首个获批的肾癌免疫疗法。3、4月11日,NMPA官网显示，齐鲁制药的注射用罗普司亭获批上市，用于治疗免疫性血小板减少症（ITP）。这是国内首个获批上市的罗普司亭生物类似药。罗普司亭是一款二代长效血小板生成素（TPO）受体激动剂，原研由安进开发，协和发酵麒麟拥有该产品在大中华区、韩国、新加坡、马来西亚等地区的开发权利。4、4月11日，NMPA官网显示，智核生物的人促甲状腺素注射液获批上市，用于无远处转移分化型甲状腺癌患者在甲状腺全切或近全切术后碘[131I]清除残余甲状腺组织的治疗。该产品由智核生物研发，药学部分由苏州康宁杰瑞开发，其主要成分为重组人促甲状腺激素（rhTSH），是一种与天然人促甲状腺激素相同的蛋白质。5、4月11日，NMPA官网显示，三生制药的重组人血小板生成素注射液（商品名：特比澳）新适应症获批，用于治疗儿童或青少年的持续性或慢性原发免疫性血小板减少症（ITP）。该产品是由三生制药研发和生产的重组人血小板生成素注射液。申请6、4月11日，CDE官网显示，金赛药业的注射用金纳单抗申报上市，这也是国内首个申报上市的IL-1β单抗。金纳单抗是一种抗白介素1-β（IL-1β）全人源单克隆抗体。目前，全球范围内仅有一款IL-1β单抗获批上市，即诺华的卡那奴单抗，但该产品尚未进入中国市场。7、4月11日，CDE官网显示，康泰生物的Sabin株脊髓灰质炎灭活疫苗（Vero细胞）申报上市，可用于预防由脊髓灰质炎1型、2型和3型病毒感染导致的脊髓灰质炎。与传统的脊髓灰质炎灭活疫苗和脊髓灰质炎减毒活疫苗相比，Sabin株脊髓灰质炎灭活疫苗（Vero细胞）结合了这两种传统疫苗安全的优势。8、4月12日，CDE官网显示，BMS的罗特西普新适应症申报上市，推测用于治疗骨髓增生异常综合征（MDS）。该产品于2022年1月首次在国内获批上市，用于治疗需要定期输注红细胞且红细胞输注≤15单位/24周的β-地中海贫血成人患者。罗特西普是一款全球首创的红细胞成熟剂。临床批准       9、4月7日，CDE官网显示，华东医药的索米妥昔单抗注射液获批临床，联合贝伐珠单抗用于二线含铂化疗后未出现疾病进展的叶酸受体α（FRα）阳性复发性铂敏感上皮性卵巢癌、输卵管癌或原发性腹膜癌成人患者的维持治疗。索米妥昔单抗为中美华东与ImmunoGen（已被艾伯维收购）合作开发的针对FRα靶点的抗体偶联药物（ADC）。10、4月10日，CDE官网显示，丹码生物（D2MBiotherapeutics）的DM919获批临床，拟用于治疗实体瘤。DM919是丹码生物自主研发的靶向MICA/B蛋白的人源化单抗，MICA/B蛋白是一种NK/T细胞检查点抑制剂。11、4月11日，CDE官网显示，恒瑞医药的HRS-9231注射液获批临床，拟用于治疗全身各部位MRI检测和显示异常血管病变。HRS-9231注射液是其开发的一款新型MRI造影剂，能显著改善组织对磁场的反应，进而提升MRI图像的对比度，使人体内部结构和异常情况的观察更为清晰。12、4月11日，CDE官网显示，恒瑞医药的SHR-4597吸入剂获批临床，拟用于支气管哮喘维持治疗。SHR-4597为该公司开发的一款新型吸入制剂，预期可以通过阻断哮喘的重要炎症通路，发挥局部高效抗炎作用。13、4月11日，CDE官网显示，恒瑞医药的SHR-2173注射液获批临床，拟用于治疗系统性红斑狼疮。SHR-2173注射液是其开发的治疗用生物制品，能够通过靶向异常激活的免疫细胞，发挥抗炎和抑制免疫的生物学效应，有望降低自身抗体水平，改善系统性红斑狼疮患者的疾病活动状态。申请14、4月10日，CDE官网显示，诺和诺德（NovoNordisk）1类新药amycretin片申报临床，拟用于减重。该产品是诺和诺德开发的一款口服GLP-1受体和胰淀素受体的长效共激动剂，为新一代减重疗法。优先审评15、4月8日，CDE官网显示，罗氏的inavolisib拟纳入优先审评程序，与哌柏西利和内分泌疗法联合用药治疗PIK3CA突变、激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性、局部晚期或转移性乳腺癌成人患者。Inavolisib是一款口服、高选择性PI3Kα抑制剂。突破性疗法16、4月9日，CDE官网显示，百利天恒的注射用BL-B01D1拟纳入突破性治疗品种，用于既往经PD-1/PD-L1单抗治疗且经至少两线化疗（至少一线含铂）治疗失败的复发性或转移性鼻咽癌患者。BL-B01D1是一款EGFR×HER3双特异性抗体偶联药物（ADC）。该产品治疗鼻咽癌的Ⅲ期临床研究目前正在进行中。FDA临床批准17、4月8日，FDA官网显示，智康弘义的BC2027获批临床。BC2027是靶向GPC3的抗体偶联药物（ADC），该分子采用了对肝细胞癌、鳞状非小细胞肺癌等肿瘤更敏感、且具有旁观者效应的有效载荷（Payload）以提升肿瘤杀伤活性。18、4月11日，FDA官网显示，同源康医药的TYK-01054获批临床。TYK-01054正是一款小分子YAP/TEAD抑制剂，拟用于治疗多种晚期肿瘤，如恶性间皮瘤、头颈鳞状细胞癌、食管癌、胰腺癌、神经鞘瘤和肉瘤等。突破性疗法19、4月7日，FDA官网显示，迪哲医药的舒沃替尼片（商品名：舒沃哲）被授予突破性疗法认定，用于一线治疗携带表皮生长因子受体（EGFR）20号外显子插入（exon20ins）突变的晚期非小细胞肺癌（NSCLC）患者。该药于2023年8月在国内获批上市，是目前全球唯一获批针对EGFRexon20ins突变型晚期NSCLC的小分子TKI。快速通道资格20、4月8日，FDA官网显示，凡恩世的PT217被授予快速通道资格，用于治疗接受铂类药物化疗后出现疾病进展的广泛期小细胞肺癌（ES-SCLC）患者，无论其是否接受过免疫检查点抑制剂联合治疗。PT217是一款具有天然IgG结构的双特异性抗体，靶向DLL3和CD47。21、4月9日，FDA官网显示，先声药业的SIM0500被授予快速通道资格，用于既往接受过≥3线治疗（包括一种蛋白酶体抑制剂、一种免疫调节剂及一种抗CD38单克隆抗体），且对于已知可以提供临床获益的标准治疗耐药，或无法耐受的多发性骨髓瘤患者。SIM0500是一种人源化GPRC5D-BCMA-CD3三特异性抗体。孤儿药资格22、4月9日，FDA官网显示，同宜医药的CBP-1019被授予孤儿药资格，用于治疗食管癌。CBP-1019是同宜医药的第二代Bi-XDC产品，这是CBP-1019继去年9月获得FDA针对胰腺癌治疗的孤儿药资格后，再一次获得孤儿药资格。研发临床状态23、4月8日，Clinicaltrials.gov显示，礼新医药启动了LM-302三线治疗CLDN18.2阳性（CLDN18.2+）胃或胃食管交界部腺癌（G/GEJ）的Ⅲ期临床试验。该产品是继IBI343和CMG901后第3款进入Ⅲ期阶段的CLDN18.2ADC。24、4月8日，药物临床试验登记与信息公示平台显示，百济神州登记了一项Bcl-2抑制剂Sonrotoclax联合BTK抑制剂泽布替尼对比Bcl-2抑制剂维奈克拉联合CD20单抗奥妥珠单抗用于初治慢性淋巴细胞白血病患者的Ⅲ期、开放性、随机、研究。25、4月10日，药物临床试验登记与信息公示平台显示，康哲药业引进的磷酸芦可替尼乳膏（商品名：Opzelura）启动了白癜风Ⅲ期临床试验。芦可替尼是Incyte开发的一种小分子JAK1/JAK2抑制剂，其片剂（商品名：Jakafi）于2011年12月在美国获批上市，其乳膏于2021年9月在美国获批上市。26、4月11日，药物临床试验登记与信息公示平台显示，石药集团的抗表皮生长因子受体（EGFR）单抗becotatug（JMT101）启动新一项Ⅲ期临床试验（n=398），拟评估JMT101联合奥希替尼与顺铂联合培美曲塞一线治疗携带EGFR20号外显子插入突变（EGFR20ins）的晚期非小细胞肺癌（NSCLC）的疗效和安全性。临床数据27、4月8日，索元生物宣布，在生物标志物指导下的国际多中心临床Ⅱb期试验ENLIGHTEN研究取得成功，DB104（liafensine）在DGM4阳性的难治性抑郁症患者中的疗效到达了主要终点及所有次要临床终点。该研究是将药物基因生物标志物应用于中枢神经系统（CNS）领域创新药的临床试验，通过精准医疗验证了liafensine在患者中的有效性和安全性。28、4月10日，万泰生物宣布，与厦门大学合作研发的重组人乳头瘤病毒6/11/16/18/31/33/45/52/58型九价HPV疫苗（大肠埃希菌）Ⅲ期主临床试验V8期访视（共设置12次访视）已完成揭盲，初步分析结果显示主要结果符合预期。交易及投融资29、4月8日，中国生物制药宣布，与勃林格殷格翰（BI）签署了合作协议。根据协议，涵盖BI的多个处于临床阶段的资产，包括3个处于临床开发阶段的资产MDM2-p53拮抗剂Brigimadlin、选择性HER2抑制剂Zongertinib和DLL3/CD3双特异性T细胞衔接器，以及若干早期临床资产。30、4月10日，Vertex宣布，和Alpine Immune达成最终协议，根据协议，Vertex将以每股65美元或约49亿美元的现金收购Alpine。Alpine的先导分子povetacicept是一种高效的B细胞活化因子BAFF和增殖诱导配体APRIL双拮抗剂。31、4月11日，Arvinas宣布，与诺华达成一项独家许可协议，诺华将获得在全球范围内开发和商业化基于Arvinas的第二代PROTAC技术开发的雄激素受体（AR）降解剂ARV-766的权益，用于治疗前列腺癌。该交易还包括Arvinas将向诺华出售其临床前AR-V7项目的资产购买协议。【智药研习社近期直播预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~