Russia’s Health Ministry has granted permission for a Phase III clinical trial of BCD-248, an original bispecific antibody developed by Biocad for the treatment of multiple myeloma, the company’s press service told GxP News. The study will be conducted at 32 clinical centres, including the National Medical Research Centre for Haematology and the National Medical Research Centre for Radiology.
BCD-248 is a bispecific antibody capable of simultaneously binding to two targets: the BCMA antigen on the surface of multiple myeloma cells and the CD3 protein on T‑cells of the immune system, GxP News explains. This activates T‑cells and directs them against tumour cells.
It became known in 2023 that Biocad had begun testing BCD-248 for multiple myeloma, GxP News notes. At that time, the plan was to evaluate the safety, efficacy and immunogenicity of the drug as monotherapy in patients with relapsed or refractory disease, and to determine the optimal dosing regimen.
The drug has already completed Phase I and Phase II clinical trials, which assessed safety, determined the therapeutic dose and administration regimen, and provided efficacy data in patients with relapsed or refractory multiple myeloma, including those whose disease no longer responded to three main therapy classes (proteasome inhibitors, immunomodulators, anti-CD38 antibodies).
Multiple myeloma is the second most common haematological malignancy, accounting for about 1% of all cancers and up to 15% of cancers of the haematopoietic and lymphoid tissues, GxP News concludes. In relapsed or refractory disease, there remains a high unmet need for new approaches, and drugs that harness the patient’s immune system are considered one of the most promising directions.