On February 13, 2024 Brii Biosciences Limited ("Brii Bio," "we," or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, reported that it has entered into agreements with VBI Vaccines, Inc. ("VBI", NASDAQ: VBIV), ensuring expansion and control of future clinical and commercial supplies of BRII-179, a late-stage clinical asset in Brii Bio’s HBV functional cure portfolio (Press release, VBI Vaccines, FEB 13, 2024, View Source [SID1234640051]).
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Under these agreements, Brii Bio will issue a $2.5 million promissory note to VBI initially. This will eliminate royalty and milestone payments for PreHevbri. Upon meeting specific conditions, the note will increase to $10 million, securing all of VBI’s intellectual properties (IP) for BRII-179, with associated payments also eliminated. In addition, subject to certain approvals, Brii Bio and VBI will work together to transfer the manufacturing technologies of BRII-179 to a site designated by Brii Bio. Upon completion of essential activities relating to such technology transfer, subject to certain potential adjustments, Brii Bio will issue up to an additional $8 million promissory note to VBI. After satisfaction of certain conditions, Brii Bio will also take control of VBI’s Rehovot-based manufacturing facilities for BRII-179 and PreHevbrio/PreHevbri for $10 million cash on or after June 30, 2024, when Brii Bio and VBI plan to enter into supply agreement under which Brii Bio will become VBI’s commercial supplier for PreHevbrio and PreHevbri.
Separately, subject to achievement of certain conditions by VBI, Brii Bio will secure an exclusive license to develop and commercialize VBI-1901, VBI’s glioblastoma (GBM) immunotherapeutic candidate, in the Asia Pacific (APAC) region excluding Japan and issue a $5 million promissory note to VBI. VBI-1901 has received fast-track and orphan drug designations from the U.S. Food and Drug Administration (FDA) and a Phase 2b study is ongoing.
"We are grateful to our VBI colleagues at the Rehovot site who despite significant challenges continued to provide uninterrupted supplies of BRII-179," said Dr. Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio. "As Brii transitions to late-stage development of HBV programs, a global manufacturing strategy becomes critically important. We look forward to working together with the biologics manufacturing experts at the Rehovot site and timely integration of our R&D and manufacturing capabilities."
About BRII-179
BRII-179 (VBI-2601) is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. BRII-179 is currently being investigated in two Phase 2 clinical trials in combination with BRII-835 or PEG-IFNα as part of a potential functional cure regimen for the treatment of chronic HBV infection.
Brii Bio licensed BRII-179 from VBI Vaccines, Inc. ("VBI") in December 2018, providing Brii Bio with commercial rights to BRII-179 in the licensed territories of China, Hong Kong, Macau, and Taiwan. The exclusive license for BRII-179 has been extended to worldwide markets since July 2023. In November 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the "NMPA") granted BRII-179 Breakthrough Therapy Designation.
About PreHevbri
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).
About VBI-1901
VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. The FDA has granted VBI-1901 Fast Track Designation and Orphan Drug Designation for the treatment of recurrent glioblastoma. These designations are intended to provide certain benefits to drug developers, including more frequent meetings with the FDA, and Accelerated Approval and Priority Review, if relevant criteria are met, among other benefits.