Leads Biolabs Gains FDA Orphan Drug Status for Innovative Antibody LBL-034 to Treat Multiple Myeloma
Thursday, November 07, 2024
Leads Biolabs announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to LBL-034. LBL-034 is a humanized bispecific T-cell engaging antibody independently developed by Leads Biolabs to treat multiple myeloma (MM).
Multiple myeloma (MM) is a rare disease affecting approximately 1% of all cancers and 10% of hematological cancers globally. Despite advancements in treatment, there remains a significant unmet need for more effective therapies. LBL-034's unique molecular design and promising clinical data make it a potential breakthrough treatment for MM patients.
LBL-034, designed using Leads Biolabs' proprietary T cell engager antibody technology platform "LeadsBodyTM," is the world's third GPRC5D-targeted CD3 T-cell engager to enter clinical trials.
It works by binding to both CD3 on T cells and the GPRC5D antigen on cancer cells, activating T cells to attack and kill cancer cells. Preclinical and early clinical data suggest that LBL-034 is more potent and less likely to cause T cell exhaustion or death compared to other similar treatments.
In July 2023, Leads Biolabs received approval from the National Medical Products Administration (NMPA) and the FDA to initiate a Phase I/II clinical trial for LBL-034 in patients with relapsed/refractory multiple myeloma (RRMM).
The trial began in November 2023 in China and has shown promising preliminary safety and efficacy data, which will be presented at the 66th ASH Annual Meeting in December 2024.
The FDA's ODD designation recognizes the significant potential of LBL-034 in treating MM and will accelerate its clinical development and global marketing.
Orphan Drug Designation provides various incentives, including tax credits, expedited regulatory review, and market exclusivity.
Source: leadsbiolabs.com
