LBL-019 / Leads Biolabs - LARVOL DELTA

Evaluation of LBL-019 Monotherapy or Combined With Anti-PD-1 Antibody in the Treatment of Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=486 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Trial primary completion date: Mar 2025 ➔ Oct 2025

Monotherapy • Trial primary completion date • Solid Tumor

Anti-TNFR2 monoclonal antibody LBL-019 in patients with advanced malignant tumors: A phase I, first-in-human, open-label, multicenter, dose escalation Study. (ASCO 2024) - P1/2 | "LBL-019 is well tolerable and has demonstrated preliminary efficacy in patients with advanced malignant tumors. Clinical trial information: NCT05223231."

Clinical • Metastases • P1 data • Anemia • Dermatology • Gastrointestinal Cancer • Hematological Disorders • Hepatocellular Cancer • Melanoma • Oncology • Pruritus • Solid Tumor

Leads Biolabs is Proud to Announce its Participation in the 2024 ASCO Annual Meeting with One Oral Presentation and Two Posters. (PRNewswire) - "These presentations will include one oral presentation, two posters, and one online publication, showcasing advancements in various cancer indications such as nasopharyngeal cancer (NPC), extrapulmonary neuroendocrine carcinoma (EP-NEC), hepatocellular carcinoma (HCC), and renal cell carcinoma (RCC)....According to the results in the oral presentation, LBL-024 demonstrated good safety profile and very promising antitumor effects in patients with advanced malignant tumors....This phase Ⅰb/Ⅱ study indicates that the combination of LBL-007 and tislelizumab is well-tolerated in patients with advanced malignant tumors....In a Phase 1 clinical study, LBL-015 has demonstrated a good safety profile and encouraging preliminary efficacy signals in patients with advanced solid tumors....The data from the Phase 1 study indicate that LBL-019 is well tolerable and has demonstrated preliminary efficacy in patients with advanced malignant tumors."

P1 data • P1/2 data • Hepatocellular Cancer • Nasopharyngeal Carcinoma • Neuroendocrine Tumor • Renal Cell Carcinoma • Solid Tumor

LBL-019, a novel TNFR2 agonist antibody, shows potent anti-tumor efficacy through preferentially activating CD8+ T cells and alleviating the suppressive effect of Treg cells (SITC 2023) - "The in-vitro and in-vivo anti-tumor activity of LBL-019 was evaluated both as a monotherapy and in combination with an anti-PD-1 antibody. The results demonstrate potent anti-tumor efficacy, supporting the advancement of LBL-019 in clinical development for the treatment of various human tumors."

Clinical • IO biomarker • Oncology • CD4 • CD8 • IFNG • IL2RA • TNFRSF1B

Evaluation of LBL-019 Monotherapy or Combined With Anti-PD-1 Antibody in the Treatment of Advanced Malignant Tumors (clinicaltrials.gov) - P1/2 | N=486 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

LBL-019, a novel anti-TNFR2 antibody, shows a potent anti-tumor efficacy in a mouse MC38 model (AACR 2022) - "LBL-019, a humanized anti-TNFR2 antibody, shows great anti-tumor efficacy in a mouse tumor model, likely due to the mechanisms involving enhanced proliferation of Teff, elevated IFN-γ release, and possibly killing of tumor cells and Treg. The data support further development of LBL-019 as a novel therapeutic antibody for cancer, and clinical trial is expected to launch early 2022."

Preclinical • Oncology • CD4 • CD8 • IFNG • TNFRSF1B