Latest Clinical Research Data on Anti-LAG3 Antibody LBL-007 will be Presented at AACR Annual Meeting 2024

American Association for Cancer Research^® (AACR) annual meeting 2024 will be held in San Diego, USA from April 5 to 10, 2024, EST. Renowned as one of the largest academic events in cancer research, AACR annual meeting attracts tens of thousands of professionals from all over the world every year, displaying researches that hold immense innovative value and clinical potential in the field of cancer therapy.

Nanjing Leads Biolabs (Leads Biolabs) will present the latest clinical research data on the safety and efficacy of its monoclonal antibody LBL-007, targeting lymphocyte activation gene-3 (LAG-3), in combination with toripalimab, for the treatment of patients with advanced malignant tumors with or without prior anti-PD-(L)1 therapy, during a poster session.

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This is a phase I/IIb, open-label, single-arm, multicenter, dose escalation/expansion clinical study conducted in China. Patients with advanced malignant tumors, including but not limited to nasopharyngeal carcinoma (NPC), non-small cell lung cancer, esophageal squamous cell carcinoma, and head and neck squamous carcinoma, were enrolled. The primary objective was to assess safety, tolerability, recommended phase II dose, pharmacokinetics, and preliminary efficacy.

By December 1, 2023, the objective response rate (ORR) and disease control rate (DCR) were 33.3% and 75.0%, respectively, in NPC patients without prior immunotherapy. Progression-free survival (PFS) data was not yet mature, but the current the median PFS was 11.9 months, indicating a promising trend. The research indicates that LBL-007, in combination with toripalimab, is well-tolerated in patients with advanced malignant tumors and has demonstrated encouraging preliminary efficacy, both in patients with advanced NPC with or without prior anti-PD-(L)1 therapy.

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said "The response rate of existing tumor immunotherapy in patients is low. The response rate of anti-PD-(L) 1 antibody is about 20% in patients with tumor-infiltrating T cells, while 20% to 30% of those who respond effectively will develop drug resistance within 2 years. In patients without tumor-infiltrating T cells, the efficacy of anti-PD-(L) 1 antibody is even worse. More than 80% of tumor patients are unresponsive or resistant to anti-PD-(L)1 antibodies, necessitating the development of next generation of effective immunotherapy regimens. This is the original intention of Leads Biolabs to develop the LBL-007 project. Being selected as a poster presentation at the AACR Annual Meeting marks the international recognition of the innovation and clinical potential of our development pipeline. Our research results provide compelling evidence for the effectiveness and safety of LBL-007 combined with anti-PD-(L)1 monoclonal antibody in the treatment of NPC and demonstrate promising prospects of its clinical development. Currently, multiple clinical studies of LBL-007, based on a global development strategy and covering several tumor types, are rapidly progressing, and are expected to bring more effective new treatment options to cancer patients.”

About LBL-007

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.

About Leads Biolabs

Nanjing Leads Biolabs Co., Ltd. is a clinical-stage biotechnology company founded in Nanjing by a team of senior U.S.-trained antibody drug developers. Since 2014, Leads Biolabs has been dedicated to the discovery and development of novel antibody drugs with independent intellectual property rights for the treatment of oncology and other major diseases of high unmet medical needs, particularly the challenges in cancer immunotherapy. Our extensive R&D pipeline consist of more than twenty novel tumor immunotherapy, autoimmunity and ADC molecules based on monoclonal and bispecific antibody technology platforms. Leads Biolabs is committed to providing safe, effective, accessible and affordable new drugs to address the unmet needs of patients around the world.