Leads Biolabs Announces First Subject Dosed In Phase Ⅰ/Ⅱ Clinical Trial To Evaluate LBL-033, An Anti-MUC16/CD3 Bispecific Antibody In Advanced Solid Tumors Including Ovarian Cancer

NANJING, China, April 27, 2023--Nanjing Leads Biolabs Co.，Ltd. (hereinafter referred to as "Leads Biolabs" or "Company") today announces that the first participant has been successfully dosed in a Phase Ⅰ/Ⅱ, first in human, multicenter, open-labeled, dose escalation and expansion study of LBL-033, an anti-MUC16/CD3 bispecific antibody in subjects with advanced malignant tumors including ovarian cancer at Sun Yat-sen University Cancer Center.

The study is a multicenter, open-label, dose-escalation and expansion phase Ⅰ/Ⅱ clinical study. The phase Ⅰ part aims to evaluate the safety, tolerability, and pharmacokinetics of LBL-033 for the treatment of subjects with advanced malignancies, and to provide recommended doses for subsequent clinical studies. The primary objective of the Phase Ⅱ part is to evaluate the efficacy of LBL-033.

"LBL-033 is a novel targeted immunotherapy for solid tumors and no drugs have currently been approved for this target worldwide," said Dr. Shengli Cai, Chief Medical Officer of Leads Biolabs, "Because of its excellent preclinical data, Leads Biolabs has rapidly initiated this clinical trial to evaluate its safety and efficacy in human. I look forward to bringing this novel therapeutical approach to subjects with serious and unmet medical conditions as soon as possible, especially for those with highly malignant tumors such as ovarian cancer."

About MUC16:

MUC16 (Mucin16, mucin 16) is a highly glycosylated type I transmembrane protein that is abundantly expressed in epithelial cells, providing a protective lubricating barrier against infection. However, MUC16 is abnormally highly expressed in a variety of malignant tumors, including ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cancer, endometrial cancer, pancreatic cancer, non-small cell lung cancer and gastric cancer, and is involved in the regulation of immune escape, tumor cell proliferation and metastasis.

About LBL-033:

As a T-cell engager, the bispecific antibody LBL-033 targeting MUC16-expressing tumor cells and CD3-expressing T cells, mediates cell-specific killing of MUC16-positive tumor cells by promoting the secretion of immune cytokines, and changes the tumor microenvironment in a direction favorable to tumor immunity, resulting in tumor cell death. LBL-033 has shown a dose dependent anti-tumor efficacy in animal models, with a good safety profile in cynomolgus monkeys.

LBL-033 is the first bispecific antibody targeting MUC16/CD3 and approved for clinical trial in China up to now. According to The Classification of Biological Products and the Corresponding Requirements on Application Dossier, an annex to Provisions of Drug Registration issued by the China Center for Drug Evaluation (CDE) in June 2020, this product is a therapeutic biological product of Class 1, which means an innovative biologic product that is not marketed both inside and outside China.

Nanjing Leads Biolabs Co.，Ltd. is a clinical-stage R&D biotech company founded in Nanjing by a team of senior U.S.-educated antibody drug developers. Since 2014, Leads Biolabs has been dedicated to the research and development of novel antibody drugs with independent intellectual property rights for the treatment of oncology and other major diseases, mainly focused on the unmet pharmaceutical needs, especially the problems and challenges in tumor immunotherapy areas. Leads Biolabs already have a rich R&D pipeline with more than twenty novel tumor immunotherapy antibody projects based on monoclonal antibody and bispecific antibody development technology platform. Leads Biolabs will continue to expand its innovation to provide patients with safe, effective, accessible and affordable new drugs to meet the unmet pharmaceutical needs.