Gotistobart

新的临床研究将 cesalatamig 的开发拓展至生物标志物驱动的精准肿瘤免疫治疗领域  Cesalatamig正在美国和中国开展 2 期临床研究 马里兰州罗克维尔2026年10月19日 美通社 －－ OncoC4 Inc. 是一家处于临床开发后期阶段的生物制药公司，致力于开发用于癌症和神经退行性疾病的新型药物。公司今日宣布，中国国家药品监督管理局（NMPA）已受理两项新药临床试验（IND）的申请 （CXSL2601129 and CXSL2601130）。这两项申请拟用于评估公司的差异化 PD－1VEGF 双特异性抗体 cesalatamig（AI－081）在晚期实体瘤新型联合治疗方案中的应用。 新增的 IND 将支持评估 cesalatamig 联合抗体偶联药物（ADC）用于特定实体瘤、以及联合泛RAS抑制剂用于具有特定分子特征的患者人群的临床研究。这些研究标志着OncoC4战略的重要拓展，旨在将cesalatamig打造成肿瘤免疫治疗的基石药物，并有望在多种治疗模式中增强抗肿瘤活性。 “这些新的 IND 申请获受理并进入审评程序，是 cesalatamig 开发战略演进中的重要里程碑，” OncoC4 联合创始人兼首席医学官郑盼博士表示，“我们相信，同时靶向 PD－1 和 VEGF 可为联合治疗提供高度互补的平台。通过将 cesalatamig 与新一代 ADC 以及 RAS 通路抑制剂等精准肿瘤治疗相结合，我们旨在为现有标准治疗仍难以有效控制的癌症患者开发新的治疗选择。” Cesalatamig 旨在通过对VEGF和PD－1的双重阻断，同时抑制肿瘤血管生成并增强抗肿瘤免疫应答。目前，OncoC4正在美国和中国开展临床研究，在多种肿瘤类型中评估cesalatamig的疗效。2026年9月，cesalatamig针对在接受同步或序贯PD－（L）1靶向免疫治疗及含铂化疗后进展的非小细胞肺癌（NSCLC）适应症，获得了美国FDA授予的快速通道认定（Fast Track Designation）。 Cesalatamig 与ADC 联合用药，旨在评估通过互补机制增强抗肿瘤活性的潜力，即借助 ADC 的靶向细胞毒活性，结合 PD－1VEGF 阻断所带来的免疫激活与血管正常化作用。 该精准医疗项目将评估 cesalatamig 与 RAS 信号通路抑制剂的联合应用；RAS 信号通路是实体瘤中最常发生异常调控的致癌通路之一1－2。这些研究将评估同时靶向肿瘤内在信号通路和肿瘤微环境能否在经生物标志物筛选的患者群体中带来更深且更持久的临床应答。 “在针对多种具有挑战性的癌症适应症获得 cesalatamig 单药治疗活性的临床概念验证（PoC）数据，并证实其可与化疗联合应用后，我们正进一步推进与精准疗法的合理联合，”OncoC4 联合创始人、首席执行官兼首席科学官刘阳博士表示，“这些 IND 申请进一步拓展了我们在高优先级联合治疗方案中评估 cesalatamig 的能力，并推动我们实现精准肿瘤免疫治疗的愿景。” 患者入组预计将在获 NMPA 批准并完成临床试验现场启动工作后开始。 关于 Cesalatamig Cesalatamig（AI－081）是一种差异化的 PD－1VEGF 双特异性抗体，通过对 PD－1 的高亲和力，以及对 VEGF 显著高于贝伐珠单抗类 PD－（L）1VEGF 双特异性抗体的结合亲和力，促进 PD－1 与 VEGF 阻断之间更强的协同作用。因此，cesalatamig 展现出同类最佳潜力，使其更适于在富含 PD－1 和 VEGF 的肿瘤微环境中发挥作用。Cesalatamig 还具有更有效的 Fc 沉默修饰，可避免 PD－1 阳性效应 T 细胞的耗竭。2026年9月，美国食品药品监督管理局（FDA）授予 cesalatamig 快速通道认定，用于治疗在接受同步或序贯 PD－（L）1 靶向免疫治疗及含铂化疗后疾病进展的非小细胞肺癌（NSCLC）患者。 关于 OncoC4 OncoC4 总部位于马里兰州罗克维尔，是一家私人控股的晚期临床阶段生物制药公司，专注于发现和开发治疗癌症与免疫性疾病包括神经退行性疾病的新型生物制剂。OncoC4 的管线包含具有同类首创和同类最佳潜力的资产，靶点覆盖肿瘤与免疫疾病领域的新颖及经过充分验证的靶点。其中，cesalatamig 是一款全资拥有、高度差异化的 PD－1VEGF 双特异性抗体，目前正在多个肿瘤适应症中快速推进全球临床开发。Tasafustobart （ONC－841） 是一款同类首创的抗 SIGLEC－10 抗体，目前正在肿瘤适应症中开展 2 期试验、在神经退行性疾病中开展 1 期试验。此外，OncoC4 近期在美国启动了一项 ONC－783 首次人体试验 ONC－783 是一款同类首创 T 细胞衔接器，靶向在包括实体瘤和血液恶性肿瘤在内的多种癌症中选择性表达的新型 CD24 表位。OncoC4 与 BioNTech 达成战略合作，共同开发 gotistobart（BNT316ONC－392） 一款靶向 CTLA－4 的肿瘤微环境选择性 Treg 清除候选药物，覆盖多个实体瘤适应症，包括一项正在进行的鳞状非小细胞肺癌关键临床试验。 更多信息请访问：www.oncoc4.com 联系方式 媒体关系Helen Schiltzmedia＠oncoc4.com 投资者关系Ryan Cuiir＠oncoc4.com 参考文献 1. Yang X, Wu H. RAS signaling in carcinogenesis, cancer therapy and resistance mechanisms. J Hematol Oncol. 2024；17：108. doi： 10.1186s13045－024－01631－9. 2. Stites EC. The abundance of KRAS and RAS gene mutations in cancer. Methods Mol Biol. 2024；2797：1322. doi： 10.1007978－1－0716－3822－4＿2.

— New Studies Expand Cesalatamig into Biomarker-driven Precision Immuno-oncology Strategies — Cesalatamig is Also Being Evaluated in Ongoing Phase 2 Studies in the United States and in China ROCKVILLE, Md. , Oct. 19, 2026 /PRNewswire/ -- OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, today announced that the China National Medical Products Administration (NMPA) has accepted two new Investigational New Drug (IND) applications (CXSL2601129 and CXSL2601130) to evaluate cesalatamig (AI-081), the company's differentiated PD-1/VEGF bispecific antibody, in novel combination regimens for patients with advanced solid tumors. The INDs will support clinical studies evaluating cesalatamig in combination with antibody-drug conjugates (ADCs) across selected solid tumors and with pan-RAS inhibitors in molecularly defined patient populations. The studies represent an important expansion of OncoC4's strategy to establish cesalatamig as a foundational immuno-oncology backbone with the potential to enhance activity across multiple therapeutic modalities. "The acceptance of these new IND applications in China marks an important milestone in the evolution of our cesalatamig development strategy," said Dr. Pan Zheng, Co-founder and Chief Medical Officer of OncoC4. "We believe the dual targeting of PD-1 and VEGF may provide a highly complementary platform for combination approaches. By integrating cesalatamig with next-generation ADCs and precision oncology therapies such as RAS pathway inhibitors, we aim to unlock new treatment options for patients whose cancers remain difficult to treat with current standards of care." Cesalatamig is designed to simultaneously inhibit tumor angiogenesis and enhance anti-tumor immune responses through dual blockade of VEGF and PD-1. OncoC4 is evaluating cesalatamig across multiple tumor types in ongoing clinical studies in the United States and China. In September 2026, cesalatamig received U.S. FDA Fast Track Designation for non-small cell lung cancer (NSCLC) that progressed after concurrent or sequential PD-(L)1-targeted immunotherapy and platinum-based chemotherapy. The ADC combination program is intended to evaluate the potential for cesalatamig to enhance anti-tumor activity through complementary mechanisms of action, leveraging the targeted cytotoxic activity of ADCs together with immune activation and vascular normalization associated with dual PD-1/VEGF blockade. The precision medicine program will evaluate cesalatamig in combination with inhibitors of the RAS signaling pathway, one of the most frequently dysregulated oncogenic pathways across solid tumors1-2. These studies will assess whether concurrently targeting tumor-intrinsic signaling and the tumor microenvironment can produce deeper and more durable clinical responses in biomarker-selected patient populations. "Having obtained clinical proof-of-concept data demonstrating the activity of cesalatamig monotherapy in several challenging cancer indications, as well as its combinability with chemotherapy, we are now advancing rational combinations with precision therapies," said Dr. Yang Liu, Co-founder, Chief Executive Officer and Chief Scientific Officer of OncoC4. "These INDs expand our ability to evaluate cesalatamig in high-priority combinations and advance our vision of precision immuno-oncology." Patient enrollment is expected to begin following NMPA approval and completion of site activation activities. About Cesalatamig Cesalatamig (AI-081) is a differentiated PD-1/VEGF bispecific antibody designed to promote stronger cooperative interaction between PD-1 and VEGF blockade through high affinity to PD-1 and substantially higher VEGF-binding affinity than bevacizumab-based PD-(L)1/VEGF bispecific antibodies. As a result, cesalatamig shows best-in-class potential that favors its action in a PD-1 and VEGF-rich tumor microenvironment. Cesalatamig also has more effective Fc-silencing modifications to avoid the depletion of PD-1-positive effector T cells. The U.S. FDA granted cesalatamig Fast Track Designation for the treatment of non-small cell lung cancer (NSCLC) that progressed after concurrent or sequential PD-(L)1-targeted immunotherapy and platinum-based chemotherapy in September 2026. About OncoC4 Headquartered in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologics for the treatment of cancer and neurodegenerative diseases. OncoC4's pipeline features assets with first-in-class and best-in-class potential targeting both novel and well-validated targets across oncology and immunological diseases, including neurodegenerative diseases. Among them, cesalatamig is a wholly owned and highly differentiated PD-1/VEGF bispecific antibody currently undergoing rapid global clinical development in multiple oncology indications. Tasafustobart (ONC-841) is a first-in-class anti-SIGLEC-10 antibody currently in a Phase 2 trial for oncology indications and a Phase 1 trial for neurodegenerative diseases. In addition, OncoC4 recently initiated a first-in-human trial of ONC-783, a first-in-class T cell engager targeting a novel CD24 epitope selectively expressed across a broad spectrum of human cancers, including solid tumors and hematological malignancies, in the United States. OncoC4 has a strategic collaboration with BioNTech to co-develop gotistobart (BNT316/ONC-392), a tumor microenvironment-selective Treg depletion candidate targeting CTLA-4, in multiple solid tumor indications, including an ongoing pivotal clinical trial in squamous non-small cell lung cancer. More information: CONTACTS Media Relations Helen Schiltz [email protected] Investor Relations Ryan Cui [email protected] References 1. Yang X, Wu H. RAS signaling in carcinogenesis, cancer therapy and resistance mechanisms. J Hematol Oncol. 2024;17:108. doi: 10.1186/s13045-024-01631-9. 2. Stites EC. The abundance of KRAS and RAS gene mutations in cancer. Methods Mol Biol. 2024;2797:13–22. doi: 10.1007/978-1-0716-3822-4_2. 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