GUANGZHOU, China, May 02, 2024 (GLOBE NEWSWIRE) -- Guangzhou Bio-gene Technologies, a biotechnology company engaged in the discovery, development, and delivery of novel cell therapies for the treatment of blood malignancies and solid tumors, today announced that the first patient was treated with BG1805, an investigational autologous CAR-T cell therapy targeting CLL-1, a member of the C-type lectin-like receptor family.

中国广州，2024年5月2日（环球通讯社）--广州生物基因科技有限公司，一家致力于发现、开发和提供用于治疗血液恶性肿瘤和实体瘤的新型细胞疗法的生物技术公司，今天宣布第一名患者接受了BG1805治疗，BG1805是一种针对C型凝集素样受体家族成员CLL-1的研究性自体CAR-T细胞疗法。

BG1805 is being evaluated in a Phase 1 clinical study for the treatment of relapsed/refractory acute myeloid leukemia (AML), a severe disease affecting adults and children..

BG1805正在一项治疗复发/难治性急性髓细胞白血病（AML）的1期临床研究中进行评估，AML是一种影响成人和儿童的严重疾病。。

“CLL-1 is an important drug target for the treatment of AML patients. We are very excited about the preclinical profile of BG1805 and early clinical data from Investigator Initiated Trials (IIT).” said Dr. Min Luo, CTO, Guangzhou Bio-gene Technologies. “BG1805 is the first cell therapies in our pipeline that has advanced into formal clinical development, marking a major milestone for the company.”.

“CLL-1是治疗AML患者的重要药物靶标。我们对BG1805的临床前概况和研究者发起的试验（IIT）的早期临床数据感到非常兴奋。”广州生物基因技术有限公司首席技术官罗敏博士说。“BG1805是我们管道中第一个进入正式临床开发阶段的细胞疗法，标志着该公司的一个重大里程碑。”。

The ongoing Phase 1 trial of BG1805 is a multicenter, open-label study with relapsed/refractory AML. The primary objectives of the Phase 1 trial are the assessment of safety, tolerability, and identification of the recommended Phase 2 dose and lymphodepletion regimen. Key safety endpoints for the trial include treatment-emergent and treatment-related adverse events, and key efficacy endpoints include proportion of patients with complete or partial responses, proportion eligible for hematopoietic stem cell transplant, and proportion achieving minimal residual disease negative status.

正在进行的BG1805 1期临床试验是一项多中心，开放标签的复发/难治性AML研究。第一阶段试验的主要目标是评估安全性，耐受性，并确定推荐的第二阶段剂量和淋巴清除方案。该试验的关键安全性终点包括治疗紧急和治疗相关的不良事件，关键疗效终点包括完全或部分缓解的患者比例，符合造血干细胞移植条件的比例以及达到最小残留疾病阴性状态的比例。

Multiple sites for the Phase 1 clinical trial of BG1805 are now open for enrollment. For more information, visit clinicaltrials.gov (NCT06118788)..

BG1805第一阶段临床试验的多个地点现已开放注册。有关更多信息，请访问clinicaltrials.gov（NCT06118788）。。

Guangzhou Bio-gene Technologies is developing several additional innovative autologous CAR-T cell therapies directed at important blood malignancy and solid tumor targets, including CD7, GPRC5D, B7H3, Claudin18.2, CDH17 as well as allogenic CAR-γδT therapies targeting CD19 and CLL-1/CD33.

广州生物基因科技有限公司正在开发针对重要血液恶性肿瘤和实体瘤靶标的另外几种创新性自体CAR-T细胞疗法，包括CD7，GPRC5D，B7H3，Claudin18.2，CDH17以及靶向CD19和CLL-1/CD33的同种异体CAR-γδT疗法。

About BG1805

关于BG1805

BG1805 is an investigational autologous CAR-T cell therapy targeting CLL-1, currently in a Phase 1 clinical study. BG1805 has previously been studied in Investigator Initiated Studies (IIT) and has demonstrated significant efficacy in both adults and children.

BG1805是一种针对CLL-1的研究性自体CAR-T细胞疗法，目前正在进行1期临床研究。BG1805先前已在研究者发起的研究（IIT）中进行了研究，并已证明对成人和儿童均有显着疗效。

About Guangzhou Bio-gene Technologies

广州生物基因科技有限公司简介

Guangzhou Bio-gene Technologies, a biotechnology company in Guangzhou, China, is dedicated the discovery, development, and delivery of novel cell therapies for the treatment of blood malignancies and solid tumors. A leader in CAR-T cell therapies, the company has advanced one autologous CAR-T candidate into Phase 1 clinical trials, six autologous CAR-T candidates into IIT studies and two allogenic CAR-T candidates into IIT studies.

广州生物基因科技有限公司是一家位于中国广州的生物技术公司，致力于发现、开发和提供用于治疗血液恶性肿瘤和实体瘤的新型细胞疗法。作为CAR-T细胞疗法的领导者，该公司已将一名自体CAR-T候选人推进1期临床试验，将六名自体CAR-T候选人推进IIT研究，将两名同种异体CAR-T候选人推进IIT研究。

For more information, please visit www.gzbiogene.com..

有关更多信息，请访问www.gzbiogene.com。。

Contact

联系人

Guangzhou Bio-gene Technologies, Ltd.:

广州生物基因科技有限公司：

Bert E. Thomas IV +1.410.627.1734

伯特·E·托马斯四世+1.410.627.1734

bthomas@gzbiogene.com

bthomas@gzbiogene.com