Prizloncabtagene autoleucel

MILAN, June 16, 2025 /PRNewswire/ -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, presented promising four-year clinical outcomes from 48 relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) patients treated with C-CAR039 (also known as Prizloncabtagene Autoleucel) in greater China, at the European Hematology Association (EHA) 2025 Congress. The study evaluated the safety and efficacy of C-CAR039, a novel anti-CD19/CD20 bi-specific CAR-T therapy. The dual-targeting approach to both CD20 and CD19 antigens aims to enhance therapeutic efficacy and reduce the likelihood of antigen escape, a common mechanism of resistance in B-cell malignancies. Key Findings: The overall response rate (ORR) and complete response (CR) rate were 91.5% and 85.1%, respectively for all patients Among the 43 LBCL pts, ORR and CR were 90.7% and 86.0%, respectively With a median follow-up of 45.5 months (range, 3.1–62.8), the median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were not reached KM estimates of 48-m PFS rate are 52.5% for all patients and 53.4% for LBCL patients, respectively KM estimates of 48-m OS rate are 65.4% for all patients and 66.7% for LBCL patients, respectively Safety Highlights: CRS of any grade: 93.8% | Grade ≥3: 2.1% ICANS of any grade: 6.3% | No severe cases (Grade ≥3) reported No new safety signals were observed with longer follow-up C-CAR039 has continued to show an excellent safety profile and deep and durable responses in R/R B-NHL patients, especially in those with R/R LBCL. These results continue to provide strong support for the curative potential of C-CAR039 as a next-generation therapy for R/R B-NHL. Late-stage clinical development is ongoing. "The long-term clinical outcomes data for C-CAR039 are highly encouraging, demonstrating sustained responses in patients with relapsed or refractory B-cell non-Hodgkin lymphoma," said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. "These results underscore our commitment and corporate goal to develop transformative therapies that address significant unmet medical needs in cancer." Dr. Yihong Yao, Chief Scientific Officer of AbelZeta, commented, "The strong clinical results of C-CAR039 demonstrate the added value of targeting CD20 in addition to CD19 in aggressive B-NHL. By addressing the limitations of single-antigen therapies - such as CD19 antigen escape - C-CAR039 enables deeper tissue penetration and more complete B-cell depletion. The durable responses observed support the continued advancement of C-CAR039 as a promising new treatment for patients with aggressive B-cell malignancies." For more information on the study and access to the poster presentation, please visit the EHA Library poster here. AbelZeta previously presented 30-month Phase 1 clinical trial results at the 65th American Society of Hematology (ASH) Annual Meeting in December 2023, through oral presentation #1025, as well as at EHA 2024, through poster presentation #P1475. The data with 30 months follow up was published in Blood 2025 Apr 3;145(14):1526-1535. AbelZeta Inc. (formerly known as Cellular Biomedicine Group, Inc.), entered into a worldwide collaboration and licensing agreement with Johnson & Johnson* in 2023 to develop and commercialize next-generation CAR-T cell therapies (excluding Greater China). The Phase 1 study for C-CAR039 was conducted by AbelZeta in China for the treatment of patients with B-cell non-Hodgkin lymphoma. Johnson & Johnson is evaluating the safety and efficacy of this asset (known as JNJ-90014496 outside of Greater China) through a separate study involving a global patient population. Phase 1b data for JNJ-90014496 were presented at EHA 2025 on Friday, June 13, informing the recommended Phase 2 dose and an initial assessment of safety, efficacy and pharmacokinetics in R/R LBCL patients. For more information, please visit Johnson and Johnson website: . *The legal entity to the worldwide collaboration and license agreement is Janssen Biotech, Inc., a Johnson & Johnson company. About AbelZeta Pharma, Inc. AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body's own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T therapies. Forward-Looking Statements Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company's reports. Such statements are based on the management's current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company's control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. Company Contact: Sarah Kelly Director of Communications AbelZeta Pharma, Inc. +1 (240) 552 5870 [email protected] SOURCE AbelZeta Pharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

6月14日，西比曼生物科技集团（简称“西比曼”）宣布，在2025年欧洲血液学协会（EHA）年会上公布了在大中华区接受C-CAR039（又称普龙基奥仑赛）治疗的48例复发或难治性B细胞非霍奇金淋巴瘤（R/R B-NHL）患者的四年临床随访结果，数据令人鼓舞。该研究评估了C-CAR039（一种新型CD20/CD19双特异性CAR-T疗法）的安全性和有效性。该疗法采用双靶点策略，同时靶向CD20和CD19抗原，旨在提高治疗效果并降低抗原逃逸的可能性，而抗原逃逸是B细胞恶性肿瘤常见的耐药机制。关键研究结果：所有患者的总缓解率（ORR）和完全缓解（CR）率分别为91.5%和85.1%。在43例大B细胞淋巴瘤（LBCL）患者中，ORR和CR率分别为90.7%和86.0%。中位随访时间为45.5个月（范围：3.1–62.8个月），所有患者的中位缓解持续时间（DOR）、无进展生存期（PFS）和总生存期（OS）均未达到。所有患者和LBCL患者的48个月PFS率（Kaplan-Meier估计值）分别为52.5%和53.4%。所有患者和LBCL患者的48个月OS率（Kaplan-Meier估计值）分别为65.4%和66.7%。安全性亮点：细胞因子释放综合征（CRS）的发生率为93.8%，其中≥3级CRS发生率为2.1%。免疫效应细胞相关神经毒性综合征（ICANS）的发生率为6.3%，未发生≥3级的ICANS。更长的随访时间内，未观察到新的安全性信号。西比曼生物新闻稿表示，C-CAR039在复发或难治性B细胞非霍奇金淋巴瘤患者，尤其是复发或难治性大B细胞淋巴瘤患者中，持续展现出优异的安全性和深度且持久的治疗效果。这些结果为C-CAR039作为复发或难治性B细胞非霍奇金淋巴瘤的下一代疗法的治愈潜力提供了有力支持。目前该疗法正处于后期临床开发阶段。西比曼生物董事长兼首席执行官刘必佐先生表示：“C-CAR039的长期随访结果令人备受鼓舞，展示出其对复发或难治性B细胞非霍奇金淋巴瘤患者疗效的持久性，同时也践行了我们致力于开发革命性疗法以解决癌症领域重大未满足医疗需求的承诺和目标。”西比曼生物首席科学官姚意弘博士评论道：“C-CAR039优异的临床结果证明了在侵袭性B细胞非霍奇金淋巴瘤治疗中，除靶向CD19外靶向CD20的显著附加价值。通过解决单抗原疗法（如CD19抗原逃逸）的局限性，C-CAR039能够实现更深层的组织渗透和更彻底的B细胞清除。此次观察到的持久疗效是对该疗法的再次肯定。作为针对侵袭性B细胞恶性肿瘤患者的一种有前景的新疗法，我们将继续推进C-CAR039的后续临床开发。”此前，西比曼已在2023年12月举行的第65届美国血液学会（ASH）年会上通过口头报告以及在2024年EHA大会上通过海报展示公布了30个月1期临床试验结果。随访30个月的数据已发表于2025年4月3日的Blood杂志第145卷第14期。西比曼与强生（Johnson & Johnson）于2023年达成全球合作与许可协议，以开发和商业化下一代CAR-T细胞疗法（不包括大中华区）。C-CAR039用于治疗B细胞非霍奇金淋巴瘤患者的临床1期研究由西比曼在中国开展。强生正在通过一项全球患者群体的独立研究评估该管线（在大中华区以外称为JNJ-90014496）的安全性和有效性。JNJ-90014496的临床1b期数据已于2025年6月13日（星期五）在2025欧洲血液学协会（EHA）年会上公布，其中包括复发或难治性大B细胞淋巴瘤患者的2期推荐剂量以及安全性、有效性和药代动力学的初步评估。参考资料：[1]西比曼生物在2025年EHA年会上公布C-CAR039新型CD20/CD19双靶点CAR-T治疗B细胞淋巴瘤患者的长期随访数据. From https://mp.weixin.qq.com/s/GhjfGGfi3_JJW1E7LvEpCQ免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。