FDA approves IND application for Nanjing Leads Biolabs’ bispecific antibody

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).

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.