A New Hope for TNBC: Heron Files TFDA Clinical Trial Application for AB-BNCT in Triple-Negative Breast Cancer

Source：Genetinfo

 

A New Hope for TNBC: Heron Files TFDA Clinical Trial Application for AB-BNCT in Triple-Negative Breast Cancer 

Heron Neutron Medical Corp. announced on the 25th that its proprietary B10 L-BPA Injection has been submitted to the Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare, for review as a human clinical trial application for academic research purposes. The study will be conducted in collaboration with medical institutions including Linkou Chang Gung Memorial Hospital to evaluate the safety and efficacy of Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) in patients with recurrent, locally advanced, or metastatic triple-negative breast cancer (TNBC). If approved by the regulatory authority, this study will represent an important milestone in Heron's clinical development strategy to expand AB-BNCT applications beyond established indications such as head and neck cancer into the field of highly aggressive breast cancers.

 

Triple-negative breast cancer is considered one of the most challenging subtypes of breast cancer to treat. Because TNBC cells lack expression of estrogen receptors, progesterone receptors, and HER2, conventional hormone therapies and HER2-targeted treatments are generally ineffective. Compared with other breast cancer subtypes, TNBC is clinically associated with more rapid disease progression, higher recurrence risk, and limited treatment options in advanced stages. In particular, patients with recurrent, locally advanced, or metastatic disease continue to face significant unmet medical needs. Following multiple lines of treatment, the development of differentiated therapeutic strategies with the potential for improved tumor selectivity remains a key focus in global breast cancer research. The National Cancer Institute (NCI) also recognizes recurrent and metastatic TNBC as a disease setting where individualized multimodal treatment approaches and participation in clinical trials should be considered.

 

BNCT is a precision radiotherapy strategy that combines boron-containing drugs with neutron irradiation. Its core principle involves the selective accumulation of boron agents within tumor tissues, followed by neutron irradiation that induces localized high linear energy transfer (LET) reactions, with the goal of selectively destroying tumor cells while minimizing damage to surrounding normal tissues. If approved, this clinical trial is expected to further accumulate clinical research data on AB-BNCT in the field of triple-negative breast cancer and explore its potential applications in recurrent, locally advanced, or metastatic solid tumors.

 

Mr. Leo Shen, General Manager of Heron Neutron Medical Corp., stated that Taiwan's strong medical capabilities and the established AB-BNCT clinical development platform will help expand BNCT cancer treatment applications from head and neck cancer into other indications with significant unmet medical needs, such as triple-negative breast cancer. He added that this expansion will not only help address therapeutic gaps but also broaden the application boundaries of BNCT in the solid tumor market, while further strengthening Heron's integrated development strategy across AB-BNCT systems, boron-containing drugs, treatment planning, and clinical translation platforms.