#Leads Biolabs #GPRC5D #LBL-034

Leads Biolabs Advances Cancer Therapy with First Patient Dosed in Phase Ⅱ Trial of LBL-034

Nanjing Leads Biolabs Co., Ltd., a leading biotechnology company, has made significant strides in cancer treatment by successfully dosing the first patient in its Phase Ⅱ clinical trial for LBL-034, a cutting-edge bispecific T-cell engager (TCE) targeting GPRC5D. This key milestone follows encouraging results from the Phase Ⅰ trial, where LBL-034 exhibited promising efficacy in patients with relapsed/refractory multiple myeloma (MM).

Innovative Approach to Cancer Treatment

LBL-034 is designed as a GPRC5D/CD3 T-cell engager, innovatively formatted to activate T cells against GPRC5D-positive cancer cells while minimizing nonspecific activation. This careful design optimizes the T-cell response, offering robust anti-tumor efficacy combined with an impressive safety profile—attributes that position LBL-034 as a potentially top-tier therapy in the oncology space.

In its Phase Ⅰ trials, LBL-034 demonstrated a coherent safety profile with an objective response rate (ORR) comparable to that of CAR-T cell therapies. Particularly noteworthy were the findings regarding extramedullary plasmacytomas, where LBL-034 yielded significant efficacy results. Further, the rate of minimal residual disease negativity surpassed that seen in conventional treatment approaches. Results from this pioneering study are set to be shared at the esteemed 2025 American Society of Hematology Annual Meeting.

Phase Ⅱ Trial Launch and Expectations

The newly launched Phase Ⅱ trial is a multi-center endeavor headed by prominent oncologist Professor Lu Jin from Peking University People's Hospital. Over 20 hospitals across China are participating, with the aim of rigorously evaluating the drug's efficacy and safety for a broader spectrum of relapsed/refractory plasma cell neoplasms.

Dr. Charles Cai, Chief Medical Officer at Leads Biolabs, emphasized that the successful start of this trial marks a pivotal progression in their TCE portfolio and validates their novel molecular design.