Monday, July 31, 2023
Nanjing Leads Biolabs has received approval from both the National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) applications for LBL-034, an innovative anti-GPRC5D/CD3 bispecific antibody designed to combat relapsed/refractory multiple myeloma.
The study design is a first-in-human, single-arm, multicenter, open-label, dose-escalation and expansion trial. It aims to enrol patients who have experienced relapse or refractory cases of multiple myeloma, and who have not responded to prior treatments, including at least one proteasome inhibitor (PI), one immunomodulator (IMiD), and other standard therapies.
The primary objectives of this study is to assess the safety and tolerability of LBL-034 in the enrolled patients and to determine the recommended Phase II dose of LBL-034. Furthermore, the trial will also evaluate the efficacy of LBL-034 in treating multiple myeloma.
LBL-034, a groundbreaking pharmaceutical compound, features a distinctive molecular structure that allows for targeted binding to GPRC5D-expressing tumour cells. Its high affinity for these cells enhances its effectiveness against tumours while significantly minimising the risk of activating T-cells non-specifically. This targeted approach not only boosts the drug's anti-tumour efficacy but also reduces the potential for immunotoxicity.
