San Diego, CA, USA – September 21, 2021 – HUYABIO International (HUYABIO™), the leader in accelerating global development of China’s pharmaceutical innovations, announced today the first patient treated in a pivotal trial designed to measure the safety and efficacy of HBI-8000 combined with Bristol Myers Squibb’s anti-PD-1, antibody Opdivo® (nivolumab), in patients with unresectable or metastatic melanoma. The multicenter, randomized, double blinded, placebo-controlled Phase 3 trial entitled, “Study Comparing the Investigational Drug HBI-8000 Combined with Opdivo vs. Opdivo in Patients with Advanced Melanoma,” will have a primary outcome of objective response rate and progression-free survival. Secondary outcomes include safety and overall survival. Opdivo® is a trademark of Bristol-Myers Squibb Company.
Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, “The initiation of the Phase 3 trial represents another significant milestone for HBI-8000 following the recent approval for the drug as monotherapy for the treatment of ATLL in Japan. The Company has taken another important step in expanding the clinical indications for our lead oncology asset in solid tumors. The results from our Phase 2 trial of HBI-8000 combined with Opdivo in solid tumors pointed to the important immunomodulatory activity for our drug. We are pleased to begin this global study in collaboration with Bristol Myers Squibb.”
The pivotal multi-national trial will enroll 480 patients from the United States, Europe, Australia, New Zealand and Japan. In the US Phase 2 trial, the combination of HBI-8000 with Opdivo was well tolerated with a favorable safety profile in checkpoint naïve melanoma patients who achieved a promising clinical response.
“Australia has one of the highest rates of melanoma in the world, especially relevant to the Sunshine Coast and Queensland”, said Principal Investigator Dr. Hong Shue, who treated the first patient and is from Sunshine Coast Haematology and Oncology Clinic and University of the Sunshine Coast Clinical Trials Unit. “We are really excited to participate in this HUYABIO International sponsored Phase 3 registrational clinical trial. This trial potentially offers a practice-changing, effective combination treatment of HBI-8000 with Opdivo to our patients on the Sunshine Coast. This study, if positive, may provide an additional treatment option and significant change in the metastatic melanoma treatment paradigm.”
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 Opdivo combination demonstrating an overall objective response rate of approximately 70% with a disease control rate over 90% in a cohort of checkpoint naïve patients with melanoma.
About HUYABIO International
HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.
Bob Goodenow, PhD President