Initial safety & efficacy in Urothelial Carcinoma (UC), Esophageal Squamous Cell Carcinoma (ESCC) and Biliary Tract Carcinoma (BTC) patients will be presented from clinical studies evaluating BL-B01D1, an EGFRxHER3 bispecific topoisomerase inhibitor- based antibody-drug conjugate (ADC).BL-B01D1在尿路上皮癌（UC）、食管鳞癌（ESCC）和胆道癌（BTC）的安全性和有效性数据将在本次大会上首次重磅发布, BL-B01D1是EGFRxHER3双特异性抗体药物偶联物（ADC），载荷为全新拓扑异构酶抑制剂。
Redmond, WA – September 9th, 2024 – SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, today announced that three abstracts on BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC) will be presented at the European Society for Medical Oncology (ESMO) Congress 2024 taking place on September 13–17 in Barcelona, Spain. BL-B01D1 is being jointly developed by SystImmune and Bristol Myers Squibb under an exclusive license and collaboration agreement.百利天恒的全球首创EGFRxHER3双特异性抗体药物偶联物（ADC）药物BL-B01D1的三项摘要将于2024年9月13日至17日在西班牙巴塞罗那举行的欧洲肿瘤内科学会（ESMO）年会上展示。BL-B01D1是百利天恒全资子公司SystImmune与百时美施贵宝（BMS）根据独家许可和合作协议共同开发的抗肿瘤药物。Expanded results from clinical trials of BL-B01D1 will include data from patients with advanced stages of Urothelial Carcinoma, Biliary Tract Carcinoma, and Esophageal Squamous Cell Carcinoma and having multiple cycles of prior therapies. The data to be presented at ESMO highlights continued progress in BL-B01D01 clinical development and builds upon the previously reported clinical data in lung and breast cancer patients at ASCO, ESMO and SABCS in 2023. BL-B01D1的多项临床开发项目正在持续进行，本次ESMO大会上展示的扩展研究结果包括接受过多线经治的晚期尿路上皮癌、胆道癌和食管鳞癌患者的数据，其中部分肺癌及乳腺癌患者的临床数据已于2023年ASCO、ESMO和SABCS大会上报道。"These data support our continued conviction that BL-B01D1 has a manageable safety profile and add to the body of evidence that shows encouraging signals of efficacy across a wide variety of tumors" said Jonathan Cheng, M.D., CMO of SystImmune. “This positions BL-B01D1 as a versatile therapeutic option that may address the unmet medical needs of patients with limited treatment options. We are committed to advancing this therapy through clinical trials, exploring its potential not only as a monotherapy but also in combination with other agents, to improve outcomes for cancer patients globally."SystImmune首席医学官Jonathan Cheng博士表示：”这些数据支持了我们对于BL-B01D1具有可控安全性的信心，并展示了其在多个瘤种中令人鼓舞的疗效信号。BL-B01D1作为多瘤种的治疗选择，可能为治疗选择有限的患者带来更多的治疗方案。我们将致力于通过临床试验进一步开发BL-B01D1，探索其单药及联合其他疗法的潜力，以改善全球癌症患者的预后。Details on the presentations at ESMO are below:
BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Urothelial Carcinoma (UC)
BL-B01D1，EGFRxHER3双特异性抗体药物偶联物（ADC），在局晚期或转移性尿路上皮癌（UC）患者的研究 Proffered paper session 1: GU tumours, non-prostateDingwei Ye (Shanghai, China)Friday, September 13th, 2024, 2:00 PM-3:30 PM CEST北京时间2024年9月13日星期五，晚上20:00-21:30西班牙当地时间2024年9月13日星期五，下午14:00-15:30BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Biliary Tract Carcinoma (BTC)BL-B01D1，EGFRxHER3双特异性抗体药物偶联物（ADC），在局晚期或转移性胆道癌（BTC）患者的研究Zhihao Lu (Beijing, China)
鲁智豪（北京，中国）
Onsite Poster display date/海报展示日期
Monday, September 16th, 2024
BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
BL-B01D1，EGFRxHER3双特异性抗体药物偶联物（ADC），在局晚期或转移性食管鳞状细胞癌（ESCC）患者的研究Liu Chang (Beijing, China)
刘畅（北京，中国）
Onsite Poster display date/海报展示日期
Monday, September 16th, 2024About 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.
BL-B01D1是百利天恒公司正在开发的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。
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.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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