Brii Bio Announces Signing of Asset Purchase Agreements Acquiring BRII-179 IP Rights and Completed Patient Enrollment for ENRICH Study
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.
Brii Bio (2137.HK) ha firmato accordi di acquisto di asset per acquisire i diritti di proprietà intellettuale e gli asset relativi a BRII-179 da VBI Vaccines per 18 milioni di dollari USA. Questa acquisizione elimina gli obblighi futuri di milestone e royalty verso VBI e assicura una fornitura clinica continua di BRII-179. L'azienda terminerà anche gli accordi precedenti con VBI a partire dal 14 febbraio 2024, cancellando tutti gli obblighi di pagamento eccetto un promissory note di 2,5 milioni di dollari USA.
L'azienda ha avviato diversi studi combinati contenenti BRII-179 mirati ad ottenere tassi di cura funzionale più elevati per l'infezione cronica da virus dell'epatite B (HBV). In particolare, l'arruolamento dei pazienti è stato completato per lo studio ENRICH, un trial di fase 2b che valuta il trattamento sequenziale di BRII-179 seguito dalla combinazione di elebsiran e PEG-IFNα.
Brii Bio (2137.HK) ha firmado acuerdos de compra de activos para adquirir los derechos de propiedad intelectual y los activos relacionados con BRII-179 de VBI Vaccines por 18 millones de dólares estadounidenses. Esta adquisición elimina las futuras obligaciones de hitos y regalías a VBI y asegura un suministro clínico ininterrumpido de BRII-179. La empresa también terminará los acuerdos previos con VBI a partir del 14 de febrero de 2024, cancelando todas las obligaciones de pago excepto una nota promisoria de 2,5 millones de dólares estadounidenses.
La empresa ha iniciado varios estudios combinados que contienen BRII-179, dirigidos a obtener tasas de cura funcional más altas para la infección crónica por el virus de la hepatitis B (VHB). Notablemente, se ha completado la inclusión de pacientes para el estudio ENRICH, un ensayo de fase 2b que evalúa el tratamiento secuencial de BRII-179 seguido de la combinación de elebsiran y PEG-IFNα.
Brii Bio (2137.HK)는 VBI Vaccines로부터 BRII-179와 관련된 전체 지식재산권 및 자산을 1,800만 달러에 인수하기 위한 자산 구매 계약을 체결했습니다. 이 인수로 인해 VBI에 대한 향후 마일스톤 및 로열티 의무가 면제되며 BRII-179의 지속적인 임상 공급이 보장됩니다. 회사는 2024년 2월 14일부터 VBI와의 이전 계약을 종료하고 250만 달러의 약속어음 외 모든 지불 의무를 취소합니다.
회사는 만성 B형 간염 바이러스(HBV) 감염에 대한 더 높은 기능적 치료율을 목표로 하는 BRII-179이 포함된 여러 가지 조합 연구를 시작했습니다. 특히, ENRICH 연구에 대한 환자 등록이 완료되었습니다. 이 연구는 BRII-179의 순차적 치료와 elebsiran 및 PEG-IFNα의 조합을 평가하는 2b상 시험입니다.
Brii Bio (2137.HK) a signé des accords d'achat d'actifs pour acquérir les droits de propriété intellectuelle et les actifs liés à BRII-179 auprès de VBI Vaccines pour 18 millions de dollars américains. Cette acquisition élimine les obligations futures de jalons et de redevances envers VBI et garantit un approvisionnement clinique ininterrompu de BRII-179. L'entreprise mettra également fin aux accords précédents avec VBI à partir du 14 février 2024, annulant toutes les obligations de paiement sauf une note de promesse de 2,5 millions de dollars américains.
L'entreprise a lancé plusieurs études combinées contenant BRII-179 visant à obtenir des taux de guérison fonctionnelle plus élevés pour l'infection chronique par le virus de l'hépatite B (VHB). Il est à noter que le recrutement des patients pour l'étude ENRICH est terminé, un essai de phase 2b évaluant le traitement séquentiel de BRII-179 suivi par une combinaison d'elebsiran et de PEG-IFNα.
Brii Bio (2137.HK) hat Kaufverträge abgeschlossen, um die vollständigen geistigen Eigentumsrechte und Vermögenswerte im Zusammenhang mit BRII-179 von VBI Vaccines für 18 Millionen US-Dollar zu erwerben. Diese Akquisition beseitigt zukünftige Meilenstein- und Lizenzgebührenverpflichtungen gegenüber VBI und sichert die ununterbrochene klinische Versorgung mit BRII-179. Das Unternehmen wird außerdem frühere Vereinbarungen mit VBI ab dem 14. Februar 2024 kündigen und alle Zahlungspflichten außer einem Schuldschein über 2,5 Millionen US-Dollar annullieren.
Das Unternehmen hat mehrere Kombinationstudien mit BRII-179 initiiert, die auf höhere funktionale Heilungsraten bei chronischen Hepatitis-B-Virus-(HBV)-Infektionen abzielen. Besonders bemerkenswert ist, dass die Patientenrekrutierung für die ENRICH-Studie abgeschlossen ist, eine Phase-2b-Studie, die die sequenzielle Behandlung mit BRII-179 gefolgt von einer Kombination aus elebsiran und PEG-IFNα bewertet.
- 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
- 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
"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
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
[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%
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SOURCE Brii Biosciences Limited
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