Guangzhou Bio-gene Technologies Announces Initiation of Phase I Clinical Trial for BG1805, a CAR-T Targeting CLL-1

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. 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.

“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.”

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

About 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.

About Guangzhou Bio-gene Technologies
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. For more information, please visit www.gzbiogene.com.

Contact
Guangzhou Bio-gene Technologies, Ltd.:
Bert E. Thomas IV +1.410.627.1734
bthomas@gzbiogene.com