Late-stage Hepatitis B Virus Development Programs Enter New Agreements

Brii Biosciences Limited today announced that it has entered into agreements with VBI Vaccines, Inc., 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.

Brii Bio confirmed on February 13, 2024, that it will initially issue a $2.5 million promissory note to VBI. This will eliminate royalty and milestone payments for PreHevbri. The note will increase to $10 million upon meeting specific conditions, securing all of VBI's intellectual properties 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 completing 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®, Sci-B-Vac®) 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 immunotherapeutic candidate, in the Asia Pacific 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 and is conducting a Phase 2b study.

Dr. Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio, stated in a press release, "As Brii transitions to late-stage development of HBV programs, a global manufacturing strategy becomes critically important."

"We look forward to working with the biologics manufacturing experts at the Rehovot site and timely integration of our R&D and manufacturing capabilities."

According to the U.S. CDC, Hepatitis B is a vaccine-preventable liver infection caused by the HBV. It is spread when blood, semen, or other body fluids from a person infected with the virus enter the body of someone who is not infected. Not all people newly infected with HBV have symptoms, but for those that do, symptoms can include fatigue, poor appetite, stomach pain, nausea, and jaundice.