Updated safety & efficacy data in locally advanced or metastatic breast cancer patients will be presented from a phase 1 clinical study evaluating BL-B01D1, an EGFRxHER3 bispecific topoisomerase inhibitor- based antibody-drug conjugate (ADC). 百利天恒自主研发的全球首创EGFRxHER3双抗ADC BL-B01D1,将在SABCS大会上发布其用于治疗局晚期或转移性乳腺癌患者I期临床研究的安全性和有效性更新数据。 Redmond, WA – December 11th, 2024 – SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, today announced that a poster for BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC) will be presented at the San Antonie Breast Cancer Symposium (SABCS) 2024, taking place on December 10-13 in San Antonio, Texas. BL-B01D1 is being jointly developed by SystImmune and Bristol Myers Squibb under an exclusive license and collaboration agreement. 2024年12月10-13日,第47届圣安东尼奥乳腺癌研讨会(SABCS)在美国得克萨斯州圣安东尼奥举行。百利天恒全资子公司SystImmune将在此次大会上展示BL-B01D1的最新数据。 Updated results from clinical trials of BL-B01D1 will include data from patients with advanced stage triple-negative, HR-positive / HER2-negative, and HER2-positive breast cancer. The data to be presented at SABCS highlights continued progress of BL-B01D01 clinical development and builds upon the previously reported clinical data in lung, breast and bladder cancer patients. 此次展示的数据将包括BL-B01D1用于晚期三阴性乳腺癌、HR阳性/HER2阴性以及HER2阳性乳腺癌患者的临床试验更新的结果。此次在SABCS上发布的数据展示了BL-B01D1临床开发项目的持续进展,为此前报告过的肺癌、乳腺癌和膀胱癌患者的数据做进一步补充。 "These data substantially adds to the body of evidence that shows encouraging signals of efficacy in main breast cancer subtypes and strengthens our conviction that BL-B01D1 has a manageable safety profile. " said Jonathan Cheng, M.D., CMO of SystImmune. “We are committed to continuing the development of this therapy through clinical trials and exploring its potential both as a monotherapy and in combination with other agents, to improve outcomes for cancer patients globally." 百利天恒全资子公司SystImmune的首席医学官(CMO)Jonathan Cheng博士表示:“这些数据进一步充实了BL-B01D1在乳腺癌主要亚型中令人鼓舞的疗效证据,并进一步增强了我们对BL-B01D1具有可控安全性的信心。”他补充道:“我们致力于继续通过临床试验推进这一药物的开发,并探索其作为单一疗法和与其他药物联合治疗的潜力,以期改善全球肿瘤患者的预后。” Details on the presentations at SABCS are below: BL-B01D1, a first-in-class EGFRxHER3 bispecific antibody-drug conjugate, in patients with Locally Advanced or Metastatic Breast Cancer and other Solid Tumor: Updated results from a Phase I study Presentation Number: P5-07-27/Abstract SESS-630 Speaker: Jiong Wu, M.D. Onsite Poster display date: Friday, December 13th, 2024 BL-B01D1,同类首创EGFRxHER3双特异性抗体药物偶联物,在局晚期或转移性乳腺癌及其他实体瘤患者中的I期临床研究结果的更新 About BL-B01D1 The company is developing BL-B01D1, a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3. These proteins are highly expressed in most epithelial tumors. The tetravalent BL-B01D1 has two binding domains for distinct Growth Factor Receptors that drive cancer cell proliferation and survival. Inheriting the SI-B001 mechanisms of action, BL-B01D1 blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. Upon antibody mediated internalization, BL-B01D1 is trafficked to cancer cell lysosomes and liberates its therapeutic payload that induces genotoxic stress activating pathways leading to cancer cell death. 关于BL-B01D1 About SystImmune SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. 关于SystImmune


以下是SABCS大会上的展示详细信息:
演讲编号:P5-07-27/摘要SESS-630
讲者:吴炅博士
现场壁报展示日期:2024年12月13日,星期五(当地时间)
BL-B01D1是百利天恒正在开发的EGFRxHER3双特异性抗体药物偶联物(ADC),其靶点在大多数上皮肿瘤中高表达。BL-B01D1沿袭了SI-B001(EGFRxHER3双抗)的作用机制,通过阻断EGFR和HER3信号来抑制肿瘤细胞的增殖和生存。BL-B01D1可以通过抗体介导的内吞作用转运至肿瘤细胞的溶酶体并释放有效载荷,诱导基因毒性应激激活信号通路,最终导致肿瘤细胞死亡。
百利天恒全资子公司SystImmune,位于华盛顿州雷德蒙德,是一家处于临床阶段的生物制药公司。公司专注于利用其成熟的药物开发平台开发创新的癌症治疗方法,包括双特异性、多特异性抗体及抗体药物偶联物(ADC)。SystImmune在实体瘤和血液病领域拥有处于各临床试验阶段的众多管线。除了正在进行的临床试验外,还拥有强大的临床前管线,包括处于研发阶段或IND阶段的潜在肿瘤治疗药物,彰显了SystImmune公司在生物制药开发领域的领先实力。
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