The Combination therapy drug for TNBC (Triple Negative Breast Cancer) of BioLite was approved to proceed into phase I/II clinical trial by US FDA in Mar., 2016.

Triple-negative breast cancer (TNBC) is defined by any breast cancer that tested negative for two kinds of hormone receptors, estrogen receptor (ER) and progesterone receptor (PR),

and one kind of the human epidermal growth factor receptors, HER2/neu. Because of the absence of these three important receptors, triple-negative breast cancers do not respond

to hormonal therapy or therapies that target HER2 receptors, so triple-negative cancers often require combinatorial therapies.

BLI-1401-2 is a botanical investigational new drug. Many preclinical and clinical data suggested that BLI-1401-2 could improve immunity and antitumor activity.

A recent study indicated that BLI-1401-2 enhance antitumor and anti-metastatic activity of a tested chemotherapy drug, but also reduce chemotherapy-induced severe side effects.

Therefore, the primary purpose of this new IND will be determining the safety and recommended dose level (RDL) of BLI-1401-2 combined with chemotherapy, in a 21-day schedule.

The secondary objective is to assess the efficacy and safety of BLI-1401-2 tested with monotherapy.

For further investigation, we will collaborate with our partners to co-develop the Asia and US market for BLI-1401-2.