HUYABIO has entered into a clinical collaboration agreement with Bristol-Myers Squibb Company to evaluate the combination of HUYABIO's HBI-8000, an epigenetic immunomodifier, and Opdivo® (nivolumab), a PD-1 blocking antibody. The Phase 3 trial is designed to evaluate the safety and efficacy of the combination in subjects with unresectable or metastatic melanoma not previously treated with anti-PD-1 therapy.
"This Phase 3 trial follows our open label Phase 2 study which showed impressive clinical results for the combination of Opdivo and HBI-8000 to treat melanoma," said Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO. "HBI-8000 has been shown to enhance the efficacy of Opdivo through one of its mechanisms of action that controls acetylation and nuclear transportation of PD-L1."
HUYABIO will be the sponsor of the trial. Bristol Myers Squibb will provide Opdivo clinical drug supply for the study. Opdivo® is a registered trademark of Bristol Myers Squibb.
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HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylases causing cell cycle arrest and tumor cell death as the mechanism underlying its single agent activity against lymphoma. The drug also has immunomodulatory impact by increasing the efficacy of checkpoint inhibitors in preclinical animal models. The Company recently reported results from its ongoing Phase 2 study for the nivolumab combination demonstrating an overall objective response rate above 70% with a disease control rate over 90% in a cohort of checkpoint naïve patients with melanoma.