LBL-007 is a fully human monoclonal antibody against lymphocyte activation gene-3 (LAG-3). LAG-3 is an immune checkpoint receptor expressed on activated T cells, which exerts negative regulatory effect on these activated T cells, leading to tumor immune escape. In preclinical studies, LBL-007 was able to specifically bind to human LAG-3, stimulate IL-2 release, block LAG-3 binding to MHC Ⅱ and other ligands, and significantly inhibit tumor growth in animal models. INDs approvals were granted by NMPA and FDA on August 13, 2019 and March 27, 2020, respectively to conduct clinical research on LBL-007. Currently, LBL-007 monotherapy phase Ⅰ clinical study has completed evaluation of tolerability, safety, pharmacokinetics and preliminary efficacy in China. Meanwhile, two phase Ⅰ/Ⅱ clinical studies of LBL-007 in combination with Toripalimab (anti-PD-1 antibody) for the treatment of advanced malignancies are ongoing. Among them, the latest clinical results of the combination treatment of advanced melanoma were presented during the 2023 ASCO conference, and demonstrated encouraging efficacy signals and safety advantages.
In December of 2021, Leads Biolabs formed a licensing and collaboration agreement with BeiGene, granting BeiGene a global R&D and manufacturing license for LBL-007, as well as exclusive commercialization rights outside of Greater China. Our team is currently cooperating closely with BeiGene to conduct the global clinical development of LBL-007 in combination with Tislelizumab (anti-PD-1 monoclonal antibody, Brand name: 百泽安®) for the treatment of malignant tumors. The clinical research is in phase Ⅰb/Ⅱ stage.

LBL-015 is an anti-programmed death receptor-1 (PD-1) antibody-transforming growth factor beta receptor 2 (TGF-βR2) bifunctional antibody fusion protein. LBL-015 can block both PD-1/PD-L1 and TGF-β/TGF-βR2 signaling pathways to reverse immunosuppression and boost immune responses. In addition, LBL-015 can block TGF-β in the tumor microenvironment to further enhance immune cell response and inhibit tumor metastasis. FDA and NMPA clinical approvals were obtained on February 8, 2021 and July 1, 2021, respectively. LBL-015 is currently in Phase Ⅰ/Ⅱ clinical studies. The planned indications to study for LBL-015 are hematologic and solid tumors.

Leads Biolabs holds all rights of LBL-015 worldwide.

LBL-019 is a monoclonal antibody targeting tumor necrosis factor receptor-2 (TNFR2). LBL-019 specifically binds to TNFR2, blocks TNFR2 from binding to TNFα, and enhances immune cell activity to achieve anti-tumor effects through immunomodulatory effects. LBL-019 received NMPA and FDA clinical approvals on 2021.12.10 and 2021.12.17, respectively. LBL-019 is currently in Phase Ⅰ/Ⅱ clinical studies. The planned indications to develop for LBL-019 are hematologic and solid tumors.

Leads Biolabs holds all rights of LBL-019 worldwide.

LBL-024 is a bispecific antibody composed of anti-programmed death ligand-1 (PD-L1) and anti-4-1BB (CD137) antibodies. LBL-024 blocks immunosuppressive pathways by targeting PD-L1 and effectively localizes 4-1BB co-stimulation to TME and tumor draining lymph nodes which maximizes antitumor immunity and increase safety as well. The LBL-024 program received IND approvals from both FDA and NMPA on July 30, 2021 and September 9, 2021 respectively to conduct clinical research. Currently, phase Ⅱ clinical studies of LBL-024 have been completed and is expected to enter the key registered clinical study in 2024. The planned indications to study for LBL-024 include hematological tumors and solid tumors.
Leads Biolabs holds all worldwide rights to LBL-024.

LBL-033 is a bispecific antibody against Mucin 16 (MUC-16) and Cluster of Differentiation 3 (CD3). MUC16 is a highly glycosylated type I transmembrane protein that is abundantly expressed in epithelial cells and functions as a lubricating barrier. However, it is overexpressed in a wide range of malignant tumors such as ovarian epithelial carcinoma, endometrial carcinoma, pancreatic carcinoma, non-small cell lung cancer and gastric cancer. This overexpression can contribute to tumor cell proliferation, metastasis, immune escape. As a T-cell engager, LBL-033 can simultaneously target MUC16-expressing tumor cells and CD3-expressing T cells, mediate the specific killing of MUC16-positive tumor cells by T cells, promote immune cytokines secretion, and alter the tumor microenvironment to be favorable for tumor immunity, thereby exert anti-tumor effect.
Clinical approvals by NMPA and FDA were granted on 2023.02.16 and 2023.06.12, respectively. Currently, a clinical study with LBL-033 monotherapy is in phase I/II. LBL-033 is proposed to be studied for a variety of solid tumors, including ovarian cancer. The indications to be studied with LBL-033 are various solid tumors such as ovarian cancer.

Leads Biolabs holds all rights of LBL-033 worldwide.
 

LBL-034 is a humanized IgG1 subtype asymmetric bispecific antibody targeting both GPRC5D (G Protein-Coupled Receptor Class C Group 5 Member D) and CD3. GPRC5D is a C-type 7-channel transmembrane receptor protein. It is expressed at low levels in normal human tissues, but is specifically overexpressed in cases of multiple myeloma. The intensity of GPRC5D expression is an independent prognostic factor in multiple myeloma, and its overexpression is significantly associated with reduced overall survival. Therefore, GPRC5D has become a crucial target for treating multiple myeloma. As a T-cell engager, LBL-034 has a unique 2:1 asymmetric structural molecular design, which allows the drug to bind specifically to GPRC5D-expressing tumor cells with high affinity, and tends to localize to tumors that highly GPRC5D expressed tumors. The monovalent form of the anti-CD3 antibody with lower affinity enables LBL-034 to activate T cells only if it binds to tumor cells, which can reduce the risk of non-specific activation of T-cells. This mechanism of action enhances anti-tumor efficacy while reducing the risk of potential immunotoxicity and T-cell depletion. LBL-034 demonstrated robust anti-tumor activities and good safety profile in pre-clinical studies, and is expected to be a Best-in-Class drug with GPRC5D-targeted immunotherapy for multiple myeloma.
The LBL-034 program received approvals for clinical studies from both FDA and NMPA on 2023.07, and is about to initiate clinical studies in patients with relapsed/refractory multiple myeloma.

Leads Biolabs holds all rights of LBL-034 worldwide.