Epcoritamab

First-of-Kind, Dual-CAR T cell Targeting CD19 and CD38 for Comprehensive Elimination of Complex, Multi-System Autoimmune Disorders Advances into Phase 1/2 Clinical Development Novel 13-point edited CAR T cell Built with a Suite of Genetic Edits and Manufactured as a Uniform Drug Product to Support Clinical Safety and Durable Efficacy in Autoimmune and Hematological Malignancies SAN DIEGO, July 09, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies broadly to patients with cancer and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for FT839, the Company’s next-generation, off-the-shelf CAR T-cell product candidate uniquely engineered to co-target CD19 and CD38. With IND clearance, the Company plans to advance FT839 into a basket clinical trial intended to evaluate the product candidate across a range of autoimmune diseases when administered in combination with standard-of-care therapy and without dependence on conditioning chemotherapy. Enrollment in the Phase 1/2 study is expected to commence in the second half of 2026. “FDA clearance of the FT839 IND is an important milestone that expands our off-the-shelf, iPSC-derived CAR T-cell platform capabilities for the comprehensive treatment of autoimmune disease, including rheumatoid arthritis,” said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. “By co-targeting CD19 and CD38, FT839 is uniquely engineered to eliminate the full spectrum of aberrant, disease-driving immune cells, including B cells, plasma cells, and activated T cells, that are often the foundation of multicellular disease found in many autoimmune disorders as well as in hematological malignancies. In addition to the incorporation of multiple genetic edits to enhance performance and safety of the drug product, FT839 also includes our patented Sword & Shield™ technology which is designed to support durable activity without dependence on conditioning chemotherapy. The remarkably homogenous pro FT839, a 13-point edited CAR T cell, is a testament to our distinct ability to genetically engineer cells and is enabled by our iPSC master cell bank platform where we have pioneered the ability to manufacture multiplex-engineered CAR T cells in a uniform and consistent manner at large scale for on-demand availability. We look forward to initiating the basket portion of this exciting Phase 1/2 study across multiple autoimmune indications and to advancing a truly accessible treatment option for patients in need.” FT839 is the Company’s second CAR T-cell product candidate to advance into clinical development for autoimmune disease, joining FT819, an off-the-shelf, CD19-targeted CAR T-cell candidate currently entering Phase 2 development in a potentially registrational trial in lupus nephritis. FT839 is designed to broaden the reach of off-the-shelf CAR T-cell therapy beyond B-cell depletion by simultaneously targeting CD19 and CD38. The elimination of B-lineage cells, including plasma cells, and CD38-expressing activated and proliferating immune cells (e.g. T cells, macrophages and NK cells) is expected to support comprehensive immune rebalancing across a diverse spectrum of autoimmune conditions. FT839 immune cell targeting can be further extended in combination with approved therapeutic monoclonal antibodies or T-cell engagers. Additionally, the Phase 1/2 trial design allows for accelerated development opportunities by avoiding the gap between separate Phase 1 and Phase 2 trials and is intended to enable assessment of both safety and efficacy data in a single trial. FT839 has been engineered with 13 targeted genetic edits that together confer multi-antigen targeting, immune evasion, and enhanced functional persistence, and that are designed to overcome key limitations of autologous patient-derived and allogeneic donor-derived CAR T-cell therapy, including manufacturing complexity, high cost, limited on-demand availability, and the requirement for intensive conditioning chemotherapy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master iPSC bank serves as the starting cell source to manufacture FT839, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT839 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population. FT839 multiplexed engineering includes the following functional elements: Dual CD19 and CD38 chimeric antigen receptors (CARs) to eliminate aberrant and pathogenic immune cells such as B cells, plasma cells, macrophages and activated T cells, as well as hematologic cancer cells of lymphoma, leukemia, and myeloma origin. High-affinity, non-cleavable CD16 (hnCD16) Fc receptor to maximize antibody-dependent cellular cytotoxicity (ADCC) in combination with approved therapeutic monoclonal antibodies (for example, rituximab or obinutuzumab), extending coverage against antigen-heterogeneous and antigen-escape populations. CD3ε Fusion Receptor (CD3FR) to support T-cell engager (TCE)–driven activation in combination with approved bispecific engagers (for example, epcoritamab, teclistamab or talquetamab). Sword & Shield™ technology (comprising an Alloimmune Defense Receptor and a CD58 genetic knockout) to selectively eliminate and evade host allogeneic immune responses, promote functional persistence, and thereby avoid the need for conditioning chemotherapy. Synthetic chemokine receptor CXCR2 and a TGFβ signal redirection receptor (TGFβ SRR) to improve trafficking to sites of pathological activity and to counter the immunosuppressive effects of the tissue microenvironment. CD38 and TRAC genetic knockouts to enhance metabolic fitness and safety pro avoiding the risk of graft versus host disease in allogeneic setting, respectively. In preclinical studies, including data presented at the 2026 American Society of Gene and Cell Therapy (ASGCT) and at the European Congress of Rheumatology (EULAR) Annual Meetings, FT839 selectively eliminated autoimmune disease drivers such as B cells, plasma cells, and activated T cells, as well as hematologic cancer cells, both as monotherapy through its dual CARs and in combination with therapeutic monoclonal antibodies and T-cell engagers. In allogeneic settings, Sword & Shield™ technology supported enhanced persistence and durable activity of FT839 without conditioning chemotherapy. The Phase 1/2 study consists of a multi-indication basket trial designed to evaluate the safety, tolerability, and preliminary activity of FT839 administered in combination with standard-of-care therapy, with or without the use of conditioning chemotherapy, in patients with autoimmune disease. The initial autoimmune indications to be evaluated in the trial are: Rheumatoid arthritis, ANCA-associated vasculitis, Idiopathic inflammatory myositis, Systemic lupus erythematosus with or without nephritis, and Systemic sclerosis. The company also plans to investigate the activity of FT839 in other autoimmune diseases, including Type 1 diabetes and multiple sclerosis, through investigator-initiated trials. Beyond autoimmune disease, the Company believes the dual-CAR mechanism of FT839 and ability to combine with therapeutic monoclonal antibodies and T-cell engagers also support its potential in hematologic malignancies, including B-cell lymphomas, leukemias, and multiple myeloma. About FT839 FT839 is the Company’s first multi-antigen dual-CAR T-cell product candidate that is designed to express two unique CARs: a first CAR targeting the B-cell lineage marker CD19 and the second CAR targeting the immune activation marker CD38, which is often found on aberrant T, NK and B cells. FT839 is the second product candidate to contain the Company’s Sword and Shield TM technology. At the 2025 ASH Annual Meeting, the Company presented preclinical data demonstrating the ability of FT839, with its dual-CAR mechanism and unique ability to synergize with monoclonal antibodies and T-cell engagers through its incorporated hnCD16 Fc receptor and CD3 fusion receptor, respectively, to specifically eliminate a variety of pathogenic immune cell types without requiring conditioning chemotherapy, suggesting its potential to broadly treat complex autoimmune diseases and hematologic malignancies. About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company's product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, including the Company’s plans to complete IND-enabling activities and submit IND applications for its product candidates, the initiation and continuation of enrollment in the Company’s clinical trials, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials and the Company’s plans to provide updates on its clinical trials, the clinical, therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, and the Company’s progress and plans relating to, and the anticipated timing and outcome of, interactions with the FDA and other regulatory authorities, including its expectations relating to alignment with regulatory authorities on potential registrational pathways for FT839 and FT819. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and risks relating to regulatory interactions and the outcome of such interactions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise. Ryan Douglas Fate Therapeutics, Inc. IR@fatetherapeutics.com

一周药闻 2026 7.6-7.12 医药快讯 NEWS 捕捉医药热点，掌握行业核心 PART .01 政策一览 7月7日，国家药监局综合司发布关于《丁基乙酰氨基丙酸乙酯》化妆品标准立项的通知 7月2日，国家药监局发布关于黄芪片转换为非处方药的公告 7月6日，根据《麻醉药品和精神药品管理条例》有关规定，国家药监局、公安部、国家卫生健康委决定将甲氧依托咪酯、乐瑞托咪酯、索安非托3个品种增列入药用类精神药品目录，自2026年10月1日起施行。 7月7日，根据药品不良反应评估结果，为进一步保障公众用药安全，国家药监局决定对猪血浆来源纤维蛋白粘合剂（包括猪源纤维蛋白粘合剂、猪纤维蛋白粘合剂）说明书内容进行统一修订。 PART .02 热点时事 《国家基本药物目录（2026年版）》正式发布 7月9日，国家卫健委、国家中医药局、国家疾控局联合发布2026年版国家基本药物目录，共收录794种药品。新增116个品种（化药生物制品68种、中成药48种），首次纳入16款创新药（含4款国产1类新药），覆盖自免、慢病等领域。新版目录将于2026年9月1日起执行。 国务院批复《中医药振兴发展“十五五”规划》 国务院于7月7日批复《中医药振兴发展“十五五”规划》，并于7月10日公开发布。规划为中医药未来五年的振兴发展指明了方向，标志着国家对中医药事业发展的持续重视与系统部署。 全球首款乙肝功能性治愈mRNA药物启动Ⅰ期临床 中国药科大学联合江苏创源生命科技研发的CPU-YL01注射液在南京正式启动Ⅰ期临床试验。该药物是全球首款针对乙肝功能性治愈的mRNA药物，已获中国、美国、老挝三地临床试验批件。 医药板块7月6日大幅拉升 7月6日，受政策利好刺激，A股和港股医药板块集体走强。创新药、仿制药、CXO指数涨幅均一度超过2%，华海药业、甘李药业、首药控股等多股涨停。 国家医保局通报药企伪造专家签名干扰集采 7月7日，国家医保局发布风险提示，在第12批集采确定采购品种阶段，某进口原研药企提交了所谓“31家医院78名医生联署的专家建议函”，试图影响集采定品，经查证80%以上签名不真实。国家医保局郑重提醒企业切勿以违法违规手段干扰集采。 PART .03 国内获批 7月9日，中国国家药监局药品审评中心（CDE）官网公示显示，默沙东（MSD）申报的1类新药恩利西肽片的上市申请获得受理，具体适应症尚未披露。 7月7日，恒瑞医药宣布，口服小分子GLP-1受体激动剂HRS-7535（大中华区外称KAI-7535，由Kailera Therapeutics开发）在中国成人肥胖及超重人群中的3期临床试验（HARBOR-1）取得积极顶线数据。 7月7日，正大天晴宣布，其开发的1类创新药TQB3126片获得中国国家药品监督管理局药品审评中心（CDE）的临床试验默示许可，拟开发用于晚期乳腺癌。 7月6日，艾伯维宣布，欧盟委员会（EC）已批准艾可来/TEPKINLY（epcoritamab，艾可瑞妥单抗）联合来那度胺和利妥昔单抗（TEPKINLY + R2方案）用于治疗成人复发或难治性（R/R）滤泡性淋巴瘤（FL）。 7月1日，深圳翰宇药业股份有限公司宣布，旗下替尔泊肽注射液的新药简略申请（ANDA）已获得美国食品药品监督管理局（FDA）受理。 7月10日，正大天晴宣布，其自主研发的IDH1抑制剂TQB3454的上市申请获中国国家药监局药品审评中心（CDE）受理，拟用于治疗伴IDH1突变的晚期胆道癌（BTC）。 7月10日，信立泰宣布其自主研发的创新药SAL0167片临床试验申请获批，可以开展高脂血症的临床试验。 关于梵晨博生 梵晨博生医药集团——γ蛋白、lgY 抗体、医疗AI大模型与新兴生物活性材料的全球领导者（源头厂家），集产、学、研、销于一体的生物医药、械（消、健、妆、食等字号）企业。 公司致力于基因工程、肿瘤免疫研究、病毒克隆、生物抗体靶向技术研究、lgY生物抗体、γ蛋白、生物蛋白、丝素蛋白、GOS/FOS益生元、益生菌、多肽、阴道微生态、明胶均聚物、卵磷脂、溶菌酶、褐藻酸盐、海藻酸钠、褐藻多糖等新兴生物活性材料的前沿开发与应用，同时与国内相关三甲医院、中科院软件所技术团队共同开展了三维AI大模型精准医疗-阿梵D的相关实践和运营。 关注集团公众号 素材来源于网络等，目的仅在于传递更多信息。若相关信息有版权问题，请在本平台留言。 往期推荐 院外需要关注的品种！梵晨博生产品目录 ACOG《宫颈癌筛查指南》更新！HPV自取样纳入主流推荐！ 梵晨博生华北三期生产基地产权证落地 锚定“十五五”新赛道，梵晨博生亮相CMEF HPV检测-治疗-防护-消杀，HPV全场景系列产品 药店增长新引擎：流感防治创新产品上市 医疗下一个风口：【AI+三维重建】  点赞+转发+在看   分享小伙伴↓↓↓