Guangzhou, China -- Bio-Thera Solutions, announced the initiation of a Phase III clinical trial evalsuating the efficacy and safety of its investigational HER2 Antibody-Drug Conjugate (ADC), BAT8001, in patients with HER-2 positive metastatic breast cancer who previously received trastuzumab separately or in combination with taxanes. The trial is designed to compare BAT8001 versus lapatinib combined with capecitabine which is 2^nd-line standard of care for metastatic breast cancer patients in China.

"Metastatic breast cancer is a difficult to treat cancer that impacts hundreds of thousands of patients around the world.  Patients with metastatic breast cancer need more treatment options that provide an improved survival benefit," said Shengfeng Li, CEO of Bio-Thera Solutions. "This Phase III trial is an important step in the development of BAT8001, potentially providing patients with metastatic breast cancer a new treatment option."

This Phase III, multicenter, randomized, open-label, controlled trial will recruit approximately 410 patients in China. The primary efficacy outcome of the trial is progression-free survival (PFS). Other pre-specified outcome measures include overall survival (OS), and objective response rate (ORR). The safety and immunogenicity of BAT8001 will also be evalsuated in the trial.

More information on the trial is available at http://www.chinadrugtrials.org.cn/ (CTR20180157).

About BAT8001
BAT8001 is an investigational HER2-ADC being evalsuated in multiple tumor types. HER2 is a naturally occurring receptor that is overexpressed in many types of cancer, including breast cancer and gastric cancer.  BAT8001 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers.  The BAT8001 clinical study program will be expanded beyond metastatic cancer to other HER2-positive cancers, including gastric cancer, over the next 12 months.

About Antibody-Drug Conjugates

Antibody-drug Conjugates or ADCs are designed to harness the targeting ability of monoclonal antibodies (mAbs) to deliver cytotoxic agents selectively to tumor cells by linking the monoclonal antibody and cytotoxic agent through a chemical linker.  An ideal ADC consists of: 1) a highly selective mAb for a tumor-associated antigen that has little or no expression on normal cells, 2) a potent cytotoxic agent designed to induce target cell death after being internalized in the tumor cell and released and 3) a chemical linker that is stable in circulation but releases the cytotoxic agent in target cells.  By selectively delivering a cytotoxic agent directly inside a tumor cell, ADCs increase the safety and tolerability of the cytotoxic agent relative to giving the cytotoxic agent systemically to the patient.

About Metastatic Breast Cancer
Metastatic breast cancer is not a specific type of breast cancer, it is breast cancer that has spread beyond the breast to other organs in the body. Metastatic breast cancer is most often found in the bones, lungs, liver or brain but can be found in other locationss in the body.  Although metastatic breast cancer has spread to another part of the body, it is still considered and treated as breast cancer.  Typically, metastatic breast cancer arises months or years after a person has completed treatment for early or locally advanced breast cancer. This is sometimes called a distant recurrence. Some patients are first diagnosed with metastatic breast cancer. This is called de novo metastatic breast cancer.  The risk of metastasis after breast cancer treatment varies from person to person and depends greatly on the biology of the tumor, the stage at the time of the original diagnosis and the treatments for the original cancer.