Brii Bio Announces Signing of Asset Purchase Agreements Acquiring BRII-179 IP Rights and Completed Patient Enrollment for ENRICH Study

Rhea-AI Summary

Brii Bio (2137.HK) has signed asset purchase agreements to acquire full intellectual property rights and assets related to BRII-179 from VBI Vaccines for US$18 million. This acquisition eliminates future milestone and royalty obligations to VBI and secures uninterrupted clinical supply of BRII-179. The company will also terminate previous agreements with VBI from February 14, 2024, canceling all payment obligations except for a US$2.5 million promissory note.

The company has initiated several BRII-179-containing combination studies targeting higher functional cure rates for chronic Hepatitis B Virus (HBV) infection. Notably, patient enrollment has been completed for the ENRICH study, a Phase 2b trial evaluating sequential treatment of BRII-179 followed by elebsiran and PEG-IFNα combination.

Positive

• Full acquisition of BRII-179 IP rights for US$18 million eliminates future milestone and royalty payments
• Secured uninterrupted clinical supply of BRII-179
• Completed patient enrollment for Phase 2b ENRICH study
• Multiple combination treatment studies initiated for HBV functional cure

Negative

• US$18 million cash outlay for IP acquisition
• Outstanding US$2.5 million promissory note payment remains due

Further secures Brii's rights in BRII-179 with full control of intellectual property, future manufacturing and supply

Several combination treatment studies containing BRII-179 have quickly started to carry forward the Company's strategy for HBV functional cure

DURHAM, N.C. and BEIJING, Dec. 31, 2024 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet medical needs announced today that it has entered into an agreement with VBI Vaccines, Inc. and certain of its subsidiaries ("VBI") and its creditor K2 VBI Equity Trust, LLC and K2 HealthVentures LLC, acquiring the intellectual property(IP) and other assets relating to BRII-179.

Under the agreement, among other matters, the Company will fully acquire the BRII-179 patents, BRII-179 know-how, and relevant BRII-179 materials, eliminating all future milestones and royalty obligations payable to VBI. The total consideration to be paid by Brii is US$18 million. Upon the closing of this transaction, Brii and VBI will also terminate their agreements announced on February 14, 2024, which were not consummated due to the discontinuation of operations of VBI. All payment obligations of Brii under the terminated agreements other than the outstanding principal amount of US$2.5 million in the form of a promissory note will be cancelled.

"This transaction ensures us with uninterrupted clinical supply of BRII-179 and complete ownership of its IP" said Dr. Zhi Hong, Ph.D., Chairman and Chief Executive Officer of Brii Bio. "It vests more value of BRII-179 in Brii's shareholders as we advance to late-stage development."

Currently Brii has started several BRII-179-containing combination studies to pursue its strategy of achieving a higher functional cure rate for the patients with chronic Hepatitis B Virus (HBV) infection. Ongoing studies continue to support that BRII-179 has the potential to identify HBV patients more responsive to curative treatments. Based on the cumulative and emerging data, a large, prospective and confirmatory Phase 2b study evaluating sequential treatment of BRII-179 followed by elebsiran and PEG-IFNα combination (the ENRICH study) is now fully enrolled.

About Hepatitis B

Hepatitis B virus (HBV) infection is one of the world's most significant infectious disease threats with more than 254 million people infected globally.^[1] Chronic HBV infection is the leading cause of liver diseases and an estimated 820,000 people die of complications from chronic HBV infection each year.^[1] HBV is of exceptional concern in China, where 87 million people are chronically infected.^[2]

About BRII-179

BRII-179 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 Bio licensed BRII-179 from VBI Vaccines, Inc. ("VBI") in December 2018 and has extended the exclusive license to global rights 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 Brii Bio

Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a 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 virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit www.briibio.com.

^[1] World Health Organization. (April 2024). Global hepatitis report 2024: action for access in low- and middle-income countries. World Health Organization. Retrieved from https://www.who.int/publications/i/item/9789240091672 

^[2] World Health Organization. Hepatitis. World Health Organization. Retrieved from https://www.who.int/china/health-topics/hepatitis#:~:text=There%20are%2087%20million%20people,living%20with%20chronic%20hepatitis%20C 

FAQ

What is the value of Brii Bio's (BRIBY) BRII-179 IP acquisition from VBI Vaccines?

Brii Bio is acquiring the BRII-179 IP rights and assets from VBI Vaccines for US$18 million.

What are the financial obligations remaining for Brii Bio (BRIBY) after the VBI agreement termination?

After terminating the February 14, 2024 agreements, Brii Bio only maintains a US$2.5 million promissory note obligation, with all other payment obligations cancelled.

What clinical trials is Brii Bio (BRIBY) conducting with BRII-179?

Brii Bio is conducting several combination treatment studies, including the Phase 2b ENRICH study, which evaluates sequential treatment of BRII-179 followed by elebsiran and PEG-IFNα combination.

What is the current status of Brii Bio's (BRIBY) ENRICH study?

The ENRICH study, a Phase 2b trial evaluating BRII-179 combination treatment, has completed patient enrollment.

What are the benefits of BRIBY's BRII-179 IP acquisition for the company?

The acquisition provides Brii Bio with full control of intellectual property, ensures uninterrupted clinical supply, and eliminates future milestone and royalty obligations to VBI.