06 July 2023 | Thursday | News
Image Source : Public Domain
Company also acquires exclusive rights to PreHevbri®, a clinically differentiated, 3-antigen prophylactic vaccine, from VBI in Greater China and Asia Pacific markets
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, today announced that it has entered into license agreements with VBI Vaccines, Inc. ("VBI", NASDAQ: VBIV), expanding the companies' collaboration in the hepatitis B virus (HBV) field.
The newly formed license agreements with VBI signify a substantial expansion in the fight against HBV infection. In the first agreement, Brii Bio's exclusive license for BRII-179 (VBI-2601) is extended to worldwide markets, further establishing its leadership position in pursuing HBV functional cure. A growing body of evidence supports the importance of a strong HBV-specific immune response to achieve a durable HBV functional cure, highlighting a potentially important role for BRII-179 as part of a combination cure strategy.
Additionally, Brii Bio will acquire exclusive rights to develop and commercialize PreHevbri® in Greater China and Asia Pacific countries including Australia, Indonesia, Malaysia, New Zealand, Philippines, Singapore, South Korea, Thailand and Vietnam, among others. PreHevbri® is a clinically differentiated 3-antigen adult HBV prophylactic vaccine recently approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel. Under the terms of the agreements, VBI will receive upfront payments of $15 million including $5 million ring-fenced for manufacturing and supply as well as $3 million equity investment by Brii Bio, contingent on achievement of near-term milestones. VBI is also eligible to receive additional payments based on achievement of regulatory and commercial milestones, as well as royalties. The transaction is subject to certain closing conditions including the satisfactory completion of VBI's financing.
"We are excited to substantially strengthen our partnership with VBI, expanding our HBV pipeline and reinforcing our commitment to public health by combatting HBV," said Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio. "By exploring the combination cure strategies across our portfolio, we aim to produce the most durable curative treatment in the broadest populations of HBV patients. The addition of PreHevbri®, VBI's prophylactic vaccine, to our HBV portfolio allows us to address HBV burdens from prevention to cure and jump-start our commercialization efforts in China and Asia Pacific with high HBV prevalence and population density, unlocking significant revenue potential."
BRII-179 (VBI-2601) is currently undergoing Phase 2 studies led by Brii Bio in China, evaluating its potential as a key component of a functional cure for chronic HBV patients. Promising results from multiple studies, including Vir Biotechnology's MARCH study and Brii Bio's ongoing Phase 2 trials combining BRII-179 (VBI-2601) with BRII-835 (VIR-2218), have shown a strong correlation between durable HBsAg seroclearance and antibody seroconversion, highlighting the potential of BRII-179 (VBI-2601) as a valuable immunomodulatory component within a functional cure regimen. Brii Bio intends to further evaluate BRII-179 as part of a combination cure strategy in upcoming studies, with a goal to substantially improve upon cure rates achieved with PEG-IFN-α alone and to expand the population of chronic HBV patients eligible for a potential cure.
PreHevbri®, also known as PreHevbrio® in the U.S. and Canada, PreHevbri® in the European Union/European Economic Area and United Kingdom, and Sci-B-Vac® in Israel, is the only approved 3-antigen HBV vaccine. In pivotal Phase 3 clinical studies, PROTECT and CONSTANT, PreHevbri® showed higher rates of and long-lasting seroprotection across all subjects aged 18+, and 5 to 8 times higher antibody titers compared to Engerix-B, a single-antigen HBV vaccine. Moreover, an integrated safety analysis of both studies demonstrated that PreHevbri® is well tolerated with no unexpected reactogenicity observed.