Brii Biosciences Announces Agreement to Acquire VBI's IP Rights in BRII-179 (VBI-2601) and Plans to Initiate Technology Transfer to Expand Clinical and Commercial Supplies
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Insights
The strategic acquisition and licensing agreements between Brii Biosciences and VBI Vaccines represent a significant financial maneuver within the biotechnology sector, with implications for both companies’ valuation and future revenue streams. The issuance of a $2.5 million promissory note, potentially increasing to $10 million, to acquire intellectual properties and eliminate future milestone and royalty payments for BRII-179, indicates a strategic move to consolidate control over key assets. This could lead to an improved net present value of future cash flows for Brii Bio, as it reduces the long-term financial obligations associated with BRII-179.
Furthermore, the potential $8 million note for technology transfer and the $10 million acquisition of manufacturing facilities underscore Brii Bio’s commitment to expanding its manufacturing capabilities. This expansion is not only a sign of growth but also a strategic investment to ensure supply chain autonomy and potentially lower production costs in the long term. Investors should monitor the company’s ability to meet the specified conditions that trigger these financial commitments, as they will directly influence the capital allocation and cash flow projections.
BRII-179's role in Brii Bio's hepatitis B virus (HBV) functional cure portfolio and VBI-1901's status as a glioblastoma (GBM) immunotherapeutic candidate with fast-track and orphan drug designations from the FDA are critical elements in assessing the clinical and commercial potential of these assets. The control over BRII-179's intellectual properties and manufacturing technologies could streamline the development process and accelerate time-to-market, pending successful clinical outcomes. The exclusive license to develop and commercialize VBI-1901 in the APAC region, excluding Japan, opens a new market segment for Brii Bio, potentially increasing its revenue base and diversifying its product pipeline.
For stakeholders, the key considerations include the efficacy and safety profiles of these assets, regulatory approval timelines and market penetration strategies for the APAC region. Successful commercialization hinges on these factors and any deviations from expected clinical trial outcomes or regulatory pathways could significantly impact the company's market position and investor confidence.
The pharmaceutical industry's competitive landscape in the APAC region is rapidly evolving, with increasing demand for innovative treatments such as immunotherapeutics for glioblastoma and functional cures for HBV. Brii Bio's strategic moves to acquire rights and expand its manufacturing footprint in this region indicate an awareness of market trends and an attempt to capitalize on the growing healthcare needs. The licensing of VBI-1901 positions Brii Bio to tap into the oncology segment, which is witnessing significant investment and patient demand.
Market penetration will depend on the successful navigation of diverse regulatory environments, local market dynamics and competition from established players and generics. The ability to manufacture and supply at scale can be a competitive advantage, potentially allowing Brii Bio to establish itself as a key player in the region. Investors should consider the long-term market potential against the immediate costs and risks associated with expanding operations and entering new therapeutic areas.
Acquiring all intellectual properties relating to BRII-179 and eliminating future milestone and royalty payments to VBI, subject to achievement of certain activities
Transferring manufacturing technologies of BRII-179 and PreHevbrio/PreHevbri to additional manufacturing sites and expanding footprint for global commercial supplies, subject to achievement of certain activities
Acquisition of VBI-1901 APAC (minus
Under these agreements, Brii Bio will issue a
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
"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
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
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.
About Brii Bio
Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a commercial stage biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious and central nervous system diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B viral infection (HBV), postpartum depression (PPD), and major depressive disorder (MDD). The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including
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SOURCE Brii Biosciences Limited
FAQ
What intellectual properties did Brii Biosciences Limited acquire?
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