Brii Builds China Ops With Hep B Assets, New Partnerships
Executive Summary
China-focused Brii Biosciences, formed earlier this year, unveils plans to take its first projects into the clinic by way of deals with VBI and Vir for hepatitis B, and builds other alliances and operations in the country.
Brii Biosciences, a startup focusing on unmet needs in the infectious disease space in China, is wasting no time in building out its operations following its founding earlier this year.
The private China and US-based venture has struck two new agreements that co-founder, president and CEO Dr Zhi Hong says together will "catapult us to a leading position in the race to deliver a functional cure for chronic hepatitis B in China."
The virus infection is highly endemic and poses a particularly significant health and economic problem in the country, where chronic hepatitis B virus (HBV) infection affects around 90 million people and is a major cause of liver disease and cancer.
China has the highest burden from the disease globally, accounting for around a third of all chronic sufferers worldwide, making HBV a natural target for Brii, set up just earlier this year.
The venture's main aim in its new deals - for a therapeutic vaccine from VBI Vaccines Inc. and an RNAi therapeutic from Vir Biotechnology Inc. - is to take forward potentially highly effective therapies for a major unmet need, Hong said.
VBI Alliance
An Asia license and collaboration agreement with US-based VBI Vaccines will give Brii rights in the Greater China area to VBI's VBI-2601, a recombinant, protein-based immuno-therapeutic vaccine for HBV.
"We were looking for a complementary asset. There is a lot of 'noise' in the [infectious] space, but VB-2601 has a very differentiated, multi-modal mechanism of action to induce and sustain a broad and effective immune response," Hong told Scrip from the US.
The deal is worth $128.5m plus royalties to VBI, which is eligible for $11m gross on closing (comprising $4m upfront and a $7m equity investment from Brii at $3.05 per share). The remaining $117.5m could come in milestones and double-digit royalties on Brii's eventual sales of the product in its licensed territories of China, Taiwan, Macau and Hong Kong.
VB-2601 boosts both B-cell and T-cell immunity, neutralizing circulating virus, blocking Pre-S1-mediated infection of hepatocytes, and helping immune-mediated clearance of infected hepatocytes.
"The induction of T-cell response is particularly critical," Hong stressed.
Under the alliance, the two companies will work to complete clinical proof-of-concept studies age in China, after which Brii will fund all further development in its territories, where it holds commercial rights. Hong disclosed that Brii hopes to start the Chinese clinical studies sometime next year.
Cambridge, Massachusetts-based VBI, listed on Nasdaq, has so far focused mainly on prophylactic vaccines, and has already commercialized in around 10 countries Sci-B-Vac for HBV. the product uses its eVLP (enveloped virus-like particle) platform technology, which mimics the target virus to elicit an immune response.
The company also has other programs in cytomegalovirus and glioblastoma.
Targeting Infectious Disease
Brii, with operations in Shanghai and Beijing, and Durham, North Carolina and San Francisco in the US, is aiming to keep its main focus on unmet public health needs in infectious diseases in China. It hit the ground running with $260m in initial committed funding and three launch partnerships.
These are with US infectious diseases venture Vir, which has granted Brii options on exclusive greater China rights to up to four of its assets, and with WuXi AppTec Inc. and WuXi Biologics for priority access to these companies' contract R&D capabilities (see side box).
In addition, it has a digital and data partnership with AliHealth, the healthcare arm of China's giant e-commerce group Alibaba, to use consumer platforms and digital data to explore novel development approaches and appropriate drug use methodologies.
The strategic focus may extend to other disease areas but not oncology, which Hong, formerly of GlaxoSmithKline PLC and Ardea Biosciences Inc., sees as very crowded, particularly in China.
Vir Partnership Expanded
The other facet of Brii's new HBV expansion builds on the existing option alliance with Vir, under which Brii says it is now intending to commence the clinical development in China of VIR-2218.
The RNA interference therapeutic (originated by and licensed from Alnylam Pharmaceuticals Inc. as ALN-HBV02) inhibits expression of all HBV proteins including the surface antigen HbsAg. It is hoped this "silencing" of all HBV RNA transcripts (needed for viral replication and protein expression) will help restore patients' innate immune response, which could potentially lead to effective cure rates.
"We plan to apply soon for approval to start clinical trials in China," Hong told Scrip.
Vir and Alnylam said at the end of November that they had initiated a Phase I/II study in the Pacific Rim with VIR-2218, which uses Alnylam's proprietary conjugate delivery technology and is delivered subcutaneously.
Other China Partnerships
As it continues to build its early activities, Brii has also initiated discovery alliances for novel immunotherapeutics with WuXi Biologics and China's Tsinghua University Institute for Immunology. The hope is to discover and develop approaches including bispecific antibodies for infections and immunologic disorders, with Brii to hold all global rights to any emerging assets.
The partners will work together to facilitate access to facilities, assays, technology, and manufacturing capability, as part of which Brii will sponsor a joint post-doctoral fellowship at Tsinghua.
The venture is also building a new R&D operational headquarters in Beijing, to gain access to local talent and regulatory expertise, and to support ongoing partnering discussions. The facility in the Haidian District will eventually house up to 200 employees.
As part of this project, Brii will enter into a public-private partnership with the district and the Beijing Commission of Science & Technology to promote public health, develop translational research capabilities, and co-ordinate resources.
Brii will in addition co-fund and provide advice on translational research to Tsinghua's School of Medicine and discovery incubators within the Tsinghua Industrial R&D Institute.
Discussions Ongoing
More generally, Hong told Scrip that the recent and ongoing regulatory reforms in China, such as expedited review and wider acceptance of foreign clinical data, were meaning that the country could join global development programs much earlier than before.
"The regulatory environment has improved significantly, and is much, much better than it was before," he commented.
Brii meanwhile is continuing to hold "a lot" of partnering discussions, including in the non-infectious disease area. "We will continue to focus on areas with public health issues and a high burden that are not adequately addressed," the CEO said.
"We will select these carefully."
From the editors of PharmAsia News.