HUYA Bioscience International expands HBI-8000 clinical trials for breast cancer

Sep 3 2015

HUYA Bioscience International (HUYA) today announced expanding clinical trials with its lead cancer drug, HBI-8000, starting with a Phase 1 combination trial in support of a breast cancer program to be conducted in the United States. HBI-8000 is a novel class I-selective oral histone deacetylase (HDAC) inhibitor which will be among the first to be included in a clinical trial involving HER2 positive advanced or metastatic cancer patients.

The inclusion of HBI-8000 combination therapy for breast cancer as a potential target is a logical extension of the drug's clinical development since it is currently in Phase 1 in Japan for Non-Hodgkin's Lymphoma, has been in several other clinical trials involving solid tumors and is now marketed in China as Epidaza for the treatment of PTCL.

HUYA reached agreement with Quantum Leap Healthcare Collaborative to obtain the I-SPY (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis) Phase 1 trial synopsis. HUYA will now conduct a clinical study to establish safety, tolerability and recommended dose for investigational agents in combination with a taxane-based chemotherapy (paclitaxel) and the targeted therapy Herceptin® (trastuzumab) for Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic cancer.

"This is an important step in the global development of this promising oral molecule as a combination therapy in solid tumors," said Mireille Gillings, Ph.D., CEO of HUYA. "What makes this line of investigation particularly interesting is the potential for an additional mode of action in the form of the immunomodulatory effects shown to be mediated by HBI-8000"

HBI-8000 inhibits tumor growth via multiple mechanisms of action, including epigenetic regulation of tumor cell division and apoptosis, immune effects such as activation of NK and CD8 T-cell-mediated antitumor activity, as well as repression of genes associated with drug resistance. Under the Tripartite Cooperation on Health between China, South Korea and Japan and given the recent approval of the drug for the treatment of PTCL in China, HUYA launched development of HBI-8000 in Japan and is now completing the first Phase 1 clinical trial in patients with NHL. The Company plans to begin a Phase 2 registration trial in 2016 based on the Pharmaceutical and Medical Devices Agency's (PMDA) acceptance of HUYA's accelerated development strategy for Japan.