US Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) have approved the Investigational New Drug (IND) applications for Nanjing Leads Biolabs’ LBL-034 bispecific antibody for treating relapsed/refractory (R/R) multiple myeloma.

LBL-034 is an IgG1 bispecific antibody that targets G protein-coupled receptor, class C, group 5, member D (GPRC5D) transmembrane receptor protein and cluster of differentiation 3 (CD3) T cell co-receptor protein. It induces T-cell-mediated cell lysis of GPRC5D expressing myeloma cells by redirecting CD3+ T-cells.

Nanjing Leads Biolabs chief medical officer Dr Charles Cai said in a press release: “LBL-034 adopts a unique molecular design, which enables the drug to specifically bind to GPRC5D-expressing tumour cells with high affinity and reduces the risk of non-specific activation of T-cells, thereby enhancing anti-tumour efficacy and reducing the potential risk of immunotoxicity.”

“LBL-034 demonstrated robust anti-tumour activities and good safety profile in pre-clinical studies.”

The single-arm, multicentre, open-label, dose-expansion Phase I clinical trial would aim to evaluate the safety and efficacy of LBL-034 in patients with R/R multiple myeloma who have received prior treatment. The additional aim of the first-in-human study is to determine the Phase II recommended dose.

In May 2023, AstraZeneca and LaNova Medicines signed a licence deal for a GPRC5D monoclonal antibody (LM-305) for R/R multiple myeloma. LM-305 has IND approval from UD FDA and China’s NMPA. Johnson & Johnson is also developing an anti-GPRC5D/CD3 bispecific antibody, talquetamab, for R/R multiple myeloma, with positive overall response data from the Phase I trial (NCT03399799).

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Other drugs in the Leads Biolabs’ pipeline include LBL-007, a monoclonal antibody developed in partnership with Chime Biologics and BeiGene to treat solid tumours, LBL-015, a bispecific antibody for treating solid tumours, and LBL-003, a monoclonal antibody in Phase I for the treatment of haematological and solid tumours.

Three antibody drugs are in Phase I/II – LBL-019 (tumour necrosis factor receptor-2 targeting monoclonal antibody) for treating haematological and solid tumours, LBL-033 (bispecific antibody for anti-mucin 16 and CD3) for solid tumours especially ovarian cancer, and LBL-024 (bispecific antibody for PDL1 and CD137) for treating haematological and solid tumours.