VBI Vaccines Inc. announced the expansion of its hepatitis B (HBV) partnership with Brii Biosciences. Through two license and collaboration agreements, Brii Bio expanded its exclusive license to VBI-2601 (BRII-179), VBI’s HBV immunotherapeutic candidate, to global rights and acquired an exclusive license for PreHevbri, VBI’s 3-antigen hepatitis B vaccine, in the Asia Pacific region (APAC). As part of the collaborations, Brii Bio will pay VBI an upfront payment of $15 million, including an equity investment of approximately $3 million, contingent on achievement of near-term milestones.

VBI is also eligible to receive up to an additional $422 million in potential regulatory and commercial milestone payments, and potential double-digit royalties in the licensed territories, which is worldwide for VBI-2601 and APAC, excluding Japan, for PreHevbri. Brii Bio will be responsible for all development, regulatory, and commercialization activities and costs for the two programs in their respective licensed territories. VBI will retain global rights to PreHevbri outside of APAC.

The transaction is subject to certain closing conditions including the satisfactory completion of a financing. VBI-2601 (BRII-179) is a novel recombinant, protein-based HBV immunotherapeutic candidate that builds upon the 3-antigen conformation of VBI’s prophylactic 3-antigen HBV vaccine candidate and is designed to target enhanced B-cell and T-cell immunity. VBI-2601 (BRII-179) is currently being evaluated in two Phase 2 clinical studies with Brii Biosciences as part of a potential functional cure for chronic hepatitis B infection.

Interim data from the Phase 2 study evaluating the combination of VBI-2601 and VIR-2218 (BRII-835), an HBV-targeting siRNA candidate, in chronically infected HBV patients were announced in February 2023 at the Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL). These data highlighted the potential of VBI-2601 as a valuable immunomodulatory component within a functional cure regimen-. Brii Bio intends to further evaluate VBI-2601 as part of a combination cure strategy in upcoming studies, with a goal to substantially improve upon cure rates achieved with PEG-IFN- a alone and to expand the population of chronic HBV patients eligible for a potential functional cure.

PreHevbri is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel. The brand names for this vaccine are: PreHevbrio® (US/Canada), PreHevbri® (EU/EEA/UK), and Sci-B-Vac® (Israel).