Brii Biosciences has announced the acquisition of full intellectual property rights to BRII-179, a novel recombinant protein-based HBV immunotherapeutic candidate, from VBI Vaccines, Inc. for US$18 million. This strategic move ensures Brii Bio's complete control over the intellectual property, future manufacturing, and supply of BRII-179, a critical component in their HBV functional cure strategy. The company also announced the completion of patient enrollment for the ENRICH study, a Phase 2b trial evaluating a sequential treatment regimen involving BRII-179.
Acquisition of BRII-179 IP Rights
The agreement with VBI Vaccines grants Brii Bio full ownership of BRII-179 patents, know-how, and relevant materials, eliminating future milestone and royalty obligations. According to Dr. Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio, "This transaction ensures us with uninterrupted clinical supply of BRII-179 and complete ownership of its IP," further stating that it "vests more value of BRII-179 in Brii’s shareholders as we advance to late-stage development."
ENRICH Study Completion and HBV Treatment Strategy
Brii Bio is currently conducting several combination studies involving BRII-179 to achieve higher functional cure rates for patients with chronic HBV infection. The ENRICH study, a large, prospective, and confirmatory Phase 2b trial, is evaluating the sequential treatment of BRII-179 followed by a combination of elebsiran and PEG-IFNα. The study has now completed enrollment.
BRII-179 is designed to induce enhanced and broad B-cell and T-cell immunity. Data from ongoing studies suggest that BRII-179 has the potential to identify HBV patients who are more responsive to curative treatments. The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) granted BRII-179 Breakthrough Therapy Designation in November 2023.
Hepatitis B Virus: A Global Health Challenge
Hepatitis B virus (HBV) infection remains a significant global health threat, with over 254 million people infected worldwide, according to the World Health Organization (WHO). Chronic HBV infection is a leading cause of liver diseases, resulting in an estimated 820,000 deaths annually. In China, approximately 87 million people are chronically infected with HBV.
