We have established independent innovative technology platforms and a rich pipeline. We have more than twenty novel anti-tumor or immuno-oncology therapeutic monoclonal antibodies or multi-specific antibodies under development, of which five (LBL-003, LBL-007, LBL-015, LBL-019, LBL-024) are in Phase Ⅰ/Ⅱ clinical studies.
LBL-003 is a recombinant fully human anti-T-lymphocyte immunoglobulin mucin-3 (TIM-3) monoclonal antibody. LBL-003 specifically binds to TIM-3 on the surface of immune cells, thereby blocking the TIM-3 pathway and restoring the anti-tumor immune response. LBL-003 received clinical approvals from both FDA and NMPA on December 21st, 2020 and May 4th, 2021, respectively. LBL-003 is currently in Phase Ⅰ clinical study to treat hematologic and solid tumors.
Leads Biolabs holds all rights of LBL-003 worldwide.
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 8th, 2021 and July 1st July, 2021, respectively. LBL-015 is currently in Phase Ⅰ/Ⅱ clinical studies. The planned indications to develop for LBL-015 are hematologic and solid tumors.
Leads Biolabs holdsall 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 December 10th December, 2021 and December 17th December, 2021, 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-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. NMPA and FDA clinical approvals were granted on August 13th, 2019 and March 27th, 2020, respectively. Currently, LBL-007 monotherapy has completed phase Ⅰ clinical studies on tolerability, safety, pharmacokinetics and preliminary efficacy in China. Meanwhile, the phase Ⅰ/Ⅱ clinical study of LBL-007 in combination with Toripalimab (anti-PD-1 antibody) for the treatment of advanced malignancies is underway, in which the latest results of the clinical trial of the combination for the treatment of advanced melanoma have been announced during the ASCO 2022 conference, demonstrated encouraging efficacy signals and safety advantages.
On December 13th, 2021, Leads Biolabs entered into a license and collaboration agreement with BeiGene to grant BeiGene a global development and manufacturing license of LBL-007, as well as an exclusive commercialization right outside of Greater China. Currently, we are closely cooperating with BeiGene in LBL007’s global clinical development, and several clinical studies of LBL-007 in combination with Tislelizumab (anti-PD-1 monoclonal antibody, trade name: 百泽安®) for the treatment of malignant tumors are in ongoing phase Ⅰb/Ⅱ clinical trials.
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 localizes4-1BB co-stimulatation to TME and tumor draining lymph nodes which maximizes antitumor immunity and increase safety as well. The LBL-024 program received clinical approvals from both FDA and NMPA on July 30th July, 2021 and September 9th September, 2021, respectively. Currently, LBL-024 is in Phase Ⅰ/Ⅱ clinical study. The planned indications to develop for LBL-024 include hematological tumors and solid tumors.
Leads Biolabs holds all rights of LBL-024 worldwide.