On June 4, 2018 HUYA Bioscience International (HUYA), the leader in accelerating global development of China’s pharmaceutical innovations, reported it is at a key stage in the company’s development of HBI-8000, HUYA’s lead novel epigenetic drug with important immunomodulatory properties (Press release, HUYA Bioscience, JUN 4, 2018, View Source [SID1234527194]). HUYA is conducting a Phase 2 trial of HBI-8000 in the US, investigating efficacy and safety in combination with nivolumab for the treatment of solid tumors. The ongoing Phase 2 study is an open label study of patients with advanced renal cell cancer, non-small cell lung cancer and melanoma.
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"We are at an important milestone in the development of HBI-8000 as we test the compound’s ability to improve the clinical benefit of checkpoint inhibitors for the treatment of solid tumors" said Dr Mireille Gillings, HUYA’s CEO and Executive Chair. "The emerging data for the combination are encouraging, leading to our ultimate goal which is to harness the demonstrated immunomodulatory properties of HBI-8000 to improve the outcome for patients treated with immunological therapies."
HBI-8000 is a member of the benzamide class of histone deacetylase (HDAC) inhibitors designed to block the catalytic pocket of Class I HDACs. Recent data show greatly expanded immunomodulatory properties which explain in greater depth the strong results now being seen in the clinic. HBI-8000 is an orally bioavailable, low-nanomolar inhibitor of cancer-associated HDAC enzymes with favorable pharmacology and safety profiles. Studies with human-derived tumor cell lines and animal tumor models have demonstrated that HBI-8000 inhibits the growth of many tumors via multiple mechanisms of action, including epigenetic regulation of tumor cell growth and apoptosis, immunomodulatory effects regulating antitumor activity, as well as repression of genes associated with drug resistance. HBI-8000 is approved in China for the treatment of peripheral T-cell lymphoma.
Dr Bob Goodenow, President, HUYA, said "We’ve targeted a significant improvement for the combination relative to nivolumab’s overall response rate, disease control rate and other clinical parameters to proceed to registration studies. Our results to date exceed expectations and clearly demonstrate the combination should be tested in a pivotal setting for the clinical benefit observed in our Phase 2 trial."