Teplizumab

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zag Bio™, Inc., a biotechnology company pioneering thymus-targeted medicines, today announced the appointment of Jan Hillson, M.D., a physician-scientist and rheumatologist with over 20 years of clinical development experience in autoimmune and inflammatory diseases across early and late stages, as Chief Medical Officer. Dr. Hillson will oversee Zag’s clinical development strategy and execution and guide pipeline advancement. She will lead Zag’s clinical team as the company prepares to advance its lead program, ZAG-101 for Type 1 diabetes, into the clinic, with a first-in-human study anticipated in late 2026. “Jan joins Zag at a pivotal moment as we transition from research into clinical development,” said Jason Cole, Chief Executive Officer of Zag Bio. “She brings extensive expertise in immunology and rheumatology, along with firsthand experience advancing disease-modifying therapies for Type 1 diabetes. Jan’s deep understanding of autoimmune disease biology will be critical as we prepare ZAG-101 for the clinic and build a broader pipeline of thymus-targeted therapies.” “Zag is advancing a fundamentally different approach to treating autoimmune disease by targeting the thymus to restore immune tolerance,” said Dr. Hillson. “This strategy has the potential to address the underlying drivers of autoimmunity rather than simply managing the metabolic outcomes for Type 1 diabetes, a disease with significant unmet need where durable disease-modifying treatments remain limited. I’m excited to join the team as Zag moves toward the clinic and works to build a pipeline designed to retrain the immune system and change the course of autoimmune disease.” Dr. Hillson previously served as Senior Vice President of Clinical Development at Provention Bio, a Sanofi Company, where she helped lead the clinical development of teplizumab for Type 1 diabetes and oversaw clinical projects in other autoimmune diseases. She has held senior leadership roles at Climb Bio, GlycoEra, Alpine Immune Sciences, ChemoCentryx, and Momenta Pharmaceuticals, and earlier served in senior roles at ZymoGenetics/Bristol Myers Squibb and Xcyte Therapies. Before entering the biotechnology industry, Dr. Hillson was a member of the clinical faculty at Harvard Medical School (Cambridge Health Alliance), Assistant Professor at the University of Washington, and Division Head at Virginia Mason Medical Center. She received her M.D. from the Stanford School of Medicine, an M.S. in environmental engineering from the California Institute of Technology, an M.S. in marine chemistry from Scripps Institute of Oceanography, and a B.S. from Michigan State University. She completed her training in immunology and rheumatology at the University of Washington. About Zag Bio Zag Bio™ has discovered a novel approach to create thymus-targeted medicines to treat and prevent autoimmune diseases by restoring central immune tolerance. Zag Bio designs bifunctional antibodies that deliver self-antigens to antigen-presenting cells in the thymus to harness the body’s natural process for training immune cells to recognize and tolerate self, halting or preventing autoimmune attacks on the body’s own tissues. Zag Bio’s pipeline includes ZAG-101, its lead program for Type 1 diabetes, as well as discovery programs for thymus-targeted therapies to address other autoimmune diseases and help patients and their caregivers. Located in Cambridge, Massachusetts, Zag Bio’s team includes experienced experts in thymus biology, autoimmune diseases and innovative drug development. Zag Bio is supported by a broad syndicate of investors, including Polaris Partners, Mission BioCapital, AbbVie Ventures, the T1D Fund, Lightspeed Ventures, Sanofi Ventures, KdT Ventures, Regeneron Ventures, Boxer Capital, Pear VC, Codon Capital, Alexandria Venture Investments and Gaingels. For more information, visit www.zagbio.com and follow us on LinkedIn.

ImmunityBio公布了CD19靶向CAR-NK疗法CD19 t-haNK针对与利妥昔单抗（抗 CD20 抗体）联合用于治疗华氏巨球蛋白血症（一种罕见的 B 细胞恶性肿瘤）在一期临床试验QUILT-106研究中的早期结果。早期数据显示部分患者的肿瘤负荷显著下降，且疗法耐受性良好，未出现严重不良反应。研究团队对这些初步结果表示乐观，认为为未来扩大样本规模和推进后续临床阶段奠定了良好基础。ImmunityBio计划继续推进这一研究，深入探索该细胞疗法在罕见淋巴瘤及其他血液肿瘤中的应用潜力。 尽管FDA新推出的“专员国家优先券”计划承诺加快药品审评进度，但由赛诺菲、勃林格殷格翰和Disc Medicine支持的多款药物审批时间仍被延后。FDA已延长礼来口服减肥药orforglipron及另外三款获得优先券药物的审评期限。根据内部监管文件，orforglipron的新目标审批日期调整至2026年4月10日。此前，该药原定的初步审批时间为3月28日，FDA高层曾希望加快审评，力争在5月20日的原定截止日期前完成决策。除了orforglipron，赛诺菲1型糖尿病治疗药物Tzield因出现安全警示（包括两次癫痫发作、一次血栓事件和一例死亡），审批时间也被推迟。针对罕见血液病卟啉症的Disc Medicine药物bitopertin，因疗效数据存疑及滥用风险，审批进度同样延缓。此外，FDA还延长了勃林格殷格翰针对非小细胞肺癌的激酶抑制剂zongertinib的审评时间。预计该药审批结果将于2月中旬公布，但其原定目标审批日期尚未明确。 这四款药物均于去年获得FDA“专员国家优先券”。该计划于2025年6月启动，旨在将药品审评周期从通常的10至12个月大幅缩短至1至2个月。优先券授予那些承诺配合政府重点医疗需求、提升美国国内制造能力，以及响应特朗普 “最惠国”药价政策的企业。FDA于去年10月首次发放首批优先券，Tzield和bitopertin均在其中。礼来和勃林格殷格翰则在11月第二轮发放中获得优先券。此后，FDA还主动将一张优先券授予了未申请该奖项的强生公司。   亚利桑那州的Strive复配药房向美国得克萨斯州西区联邦地区法院提起诉讼，指控全球医药巨头礼来与诺和诺德通过与远程医疗服务平台签订排他性合作协议，阻止这些平台与复配药房合作，从而禁止复配GLP-1类药物的销售，涉嫌联合打压市场竞争。Strive在诉状中指出，礼来和诺和诺德的行为“切断了持有个性化处方患者与能够配制这些处方的药房之间的重要渠道”，并称两家公司正在采取“协调行动，压制其减重药物市场竞争”。目前，礼来和诺和诺德尚未对诉讼作出公开回应。诺和诺德CEO此前在摩根大通医疗健康大会上曾表示，约有150万美国患者正在使用该公司GLP-1药物的复配版本，他批评复配药房“抢占了对价格敏感的消费者群体”，反映出原研厂商对复配药房快速扩张的担忧。Strive请求法院禁止礼来和诺和诺德的反竞争行为，恢复市场竞争环境，并根据法院裁决给予其他适当救济。 强生宣布其BCMA/CD3双靶向抗体药物Tecvayli在一项Ⅲ期临床试验中表现优异，显著延长了早期复发多发性骨髓瘤患者的生存时间，明显优于传统标准治疗方案。此次Ⅲ期试验招募了接受一线治疗后病情复发的多发性骨髓瘤患者，随机分配接受Tecvayli或含Velcade（硼替佐米）、Kyprolis（卡非佐米）等药物的标准治疗方案。结果显示，Tecvayli组患者在试验期间死亡或疾病进展的风险降低了71%。Tecvayli于2022年通过条件性加速审批获批，最初仅限于前线治疗失败后的第四线及以上患者使用。强生正在积极推动其向更早阶段应用，力图打造涵盖多发性骨髓瘤各病程阶段的领先产品线，该产品线还包括Darzalex、细胞疗法Carvykti和另一款双靶向抗体Talvey。此次Ⅲ期MajesTEC-9试验纳入了614例患者，主要终点为无进展生存期（PFS），而Tecvayli在延长总生存期（OS）方面也表现出显著优势，死亡风险降低了40%。因数据亮眼，研究提前解盲。Tecvayli的指导价约为每月3.9万美元。 艾伯维与Genmab联合发布消息称Epkinly在晚期弥漫性大B细胞淋巴瘤（DLBCL）三期临床试验中未能显著延长患者的总生存期（OS）。Epkinly（epcoritamab-bysp）是一种双特异性T细胞接合剂（TCE），通过同时结合T细胞上的CD3受体和B细胞（包括淋巴瘤细胞）上的CD20受体，将自身的免疫T细胞引导至癌变B细胞附近。这种双重结合激活T细胞释放细胞因子，从而杀死靶向的B细胞，有效地利用免疫系统来对抗癌症。 作为白宫与大型制药企业达成的“最惠国”药价协议之一，艾伯维宣布将未来十年内在美国医药研发和制造领域投资1000亿美元。作为回报，公司将通过降低部分药品价格，换取特朗普政府提供的三年关税豁免。艾伯维是最新加入白宫药价协议的全球十大制药巨头之一。公司表示，将向美国医疗补助计划（Medicaid）提供“低价”药品，并加大通过政府采购渠道的销售力度。涉及的药品包括Humira（修美乐）、Alphagan、Combigan和Synthroid（左甲状腺素钠片），这些产品均已专利到期，面临生物类似药和仿制药的激烈竞争。此次协议还包括艾伯维承诺未来十年内在美国的研发和资本投入达到1000亿美元，显著高于以往承诺。基于这一承诺，艾伯维获得三年关税豁免，免受特朗普政府征收的关税及未来药价管控措施的影响。辉瑞、默沙东、吉利德等制药巨头也获得了类似待遇。协议的其他条款尚未公开，艾伯维未透露该协议对公司财务指引的具体影响。2025年7月，特朗普向17家大型制药企业发出信函，要求两个月内降低药价，否则将面临未明惩罚。随后16家公司宣布达成协议，多数涉及已大幅降价或专利即将到期药品的进一步折扣。作为回报，这些企业获得三年关税豁免。 亲爱的读者，如果您对生物医药的最新动态感兴趣，或希望了解更多前沿生物科技资讯，请关注公众号。您的每一次关注和转发，都是最大的支持和鼓励！ 👉 关注大药时记，掌握更多前沿生物科技！ 👉 分享文章，让更多人受益！