US FDA Nods Biostar Pharma's IND application For Phase 2 Study

Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. (Biostar), a synthetic biology-driven biopharma firm focused on the creation and marketing of innovative oncology drugs, declared that the US FDA had approved their core pipeline product Utidelone injection (UTD1) for a phase 2 study (BG01-2402) for HER2- breast cancer brain metastasis.

Approximately 20-50% of metastatic breast cancer patients have brain metastases, based on molecular categorization. The current standard of care for BCBM is predominantly local treatment, including surgery and radiation therapy, complemented by medication therapy. Because of the blood-brain barrier (BBB) and blood-tumour barrier (BTB), many medications that are successful for extracranial metastases of breast cancer have very limited intracranial permeability, resulting in a dismal prognosis for BCBM patients, particularly those with HER2-BCBM. The mPFS for HR+/HER2- BCBM is approximately 4-6 months, whereas the mFPS for TNBC brain metastasis is only 2.8 months.

In recent years, various small-molecule TKIs and ADC medicines have improved survival rates for HER2+ BCBM patients. However, there are presently no medication treatment regimens with established efficacy for HER2- BCBM, and no medicine has been licensed globally, indicating a large unmet medical need.

Utidelone can cross the blood-brain barrier due to its unusual physicochemical properties and resistance to P-glycoprotein-mediated efflux, as evidenced by preclinical drug tissue distribution studies and multiple clinical trials. A phase 2 study using utidelone in combination with bevacizumab for the treatment of HER2-BCBM published at ASCO 2024 exhibited effectiveness outcomes of 42.6% CNS-ORR, 7.7 months mPFS, and 74.4% 12-month OS rate, with 47 eligible patients participating.