China-based Leads Biolabs Inc. has announced that it has obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its anti-PD-L1/4-1BB bispecific antibody, LBL-024. This designation is for the treatment of neuroendocrine cancer, a rare and aggressive form of cancer.
Mechanism of Action and Preclinical Efficacy
LBL-024 works by targeting PD-L1 to relieve PD-1/PD-L1 immunosuppression while also aggregating, activating, and amplifying cells in the tumor microenvironment through the co-stimulatory effect of 4-1BB. This mechanism of action allows LBL-024 to synergistically enhance the anti-tumor immune response, offering a potential new treatment option for patients with neuroendocrine cancer.
Clinical Research Initiation and Positive Results
LBL-024 received approval in the U.S. and China in July 2021 and September 2021, respectively, to commence phase I/II clinical research. The drug has achieved outstanding results in these trials, demonstrating good tolerability and controllable safety, with no new safety signals compared to current immunotherapies. The clinical data from the Phase I/II trials, which assessed the tolerability, safety, pharmacokinetics, and efficacy of LBL-024 as a monotherapy in advanced malignant tumors, show that LBL-024 has more than doubled both the objective response rate (ORR) and overall survival (OS) compared to existing treatments for this disease.-Fineline Info & Tech
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