NMPA and FDA Approve First-in-Human Trial for LBL-034 in Multiple Myeloma

01 August 2023 | Tuesday | News

Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs" or "Company") announced that the National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) have approved its first-in-human Investigational New Drug (IND) applications for LBL-034, an anti-GPRC5D/CD3 bispecific antibody invented by Leads Biolabs with global intellectual property rights, for the treatment of relapsed/refractory multiple myeloma. Currently, no GPRC5D-targeting antibody has been approved for marketing.
Image Source : Public Domain

Image Source : Public Domain

This is a first-in-human, single-arm, multicenter, open-label, dose-escalation and expansion clinical study, and plans to enroll patients with relapsed/refractory multiple myeloma who have failed prior therapies including but not limited to at least one proteasome inhibitor (PI), one immunomodulator (IMiD) as well as other standard treatments. This study aims to evaluate the safety and tolerability of LBL-034, determine the recommended Phase II dose and assess its efficacy in patients with multiple myeloma.

"Despite recent progress and continuous advancements in multiple myeloma, the time between recurrences has been steadily decreasing, particularly as the number of treatment lines increases. This ultimately leads to emergence of relapsed or refractory multiple myeloma, reaffirming its status as an incurable malignant tumor that poses a serious threat to human life. In light of this challenging reality, the urgent need for more effective and innovative treatment options has never been more evident." said Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, "LBL-034 adopts a unique molecular design, which enables the drug to specifically bind to GPRC5D-expressing tumor cells with high affinity, and reduces the risk of non-specific activation of T-cells, thereby enhancing anti-tumor efficacy and reducing potential risk of immunotoxicity. LBL-034 demonstrated robust anti-tumor activities and good safety profile in pre-clinical studies. We adhere to our tradition of innovation and aim to deliver an important, novel and effective treatment option for patients with poor prognosis of relapsed/refractory multiple myeloma."


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