First-in-Human Trials of Multiple Highly Potent, Neutralizing Antibodies Against COVID-19 on Track

Brii Biosciences (Durham, N.C., USA) has entered into a partnership and license agreement with Tsinghua University, 3rd People’s Hospital to discover, develop, manufacture and commercialize fully human neutralizing monoclonal antibodies to address the global COVID-19 pandemic.

Researchers from Tsinghua University and 3rd People’s Hospital of Shenzhen have identified multiple diverse and potent neutralizing monoclonal antibodies with therapeutic potential against SARS CoV-2 that have been characterized from patients in China who have recovered from COVID-19. Based on this research, the university and hospital, along with Brii Bio, intend to advance multiple candidates for prophylactic and therapeutic intervention. Through this effort, the three parties aim to achieve an accelerated timeline of six months from the selection of a lead development candidate to the first-in-human clinical trials, with the potential for additional timeline acceleration. Tsinghua and collaborators at 3rd People’s Hospital of Shenzhen will provide capabilities and researchers to ensure all necessary testing, screening, virologic, biochemical and cell culture characterizations. Brii Bio will provide development expertise, antibody optimization, intellectual protection, project management, CDMO management, and clinical and regulatory oversight.

“We have been able to move very quickly by virtue of our proximity to the initial outbreak and our expertise from prior research in SARS and MERS,” said Professor Linqi Zhang, Tsinghua University. “Our investigators have worked day and night since the beginning of the outbreak. With Brii Bio joining and the dedicated focus afforded by this new venture, we expect to accelerate our development efforts with the shared goal of bringing forward an effective therapy to benefit people around the world affected by this pandemic.”

“Since the beginning of the outbreak, our hospital had responded urgently to focus on searching for monoclonal antibodies against COVID-19. Our teams worked extremely hard and isolated hundreds of monoclonal antibodies early on through single B-cell sorting and rapid sequencing, thereby laying the foundation for further optimization of these neutralizing antibodies,” said Professor Zheng Zhang, 3rd People’s Hospital of Shenzhen. “Our partnership with Tsinghua and Brii Bio will accelerate the development of these neutralizing antibodies to the clinic and may help to slow down the spread of the COVID-19 pandemic.”

“Our collaboration with Tsinghua University and 3rd People’s Hospital of Shenzhen perfectly aligns with Brii Bio’s mission to make significant contributions to public health throughout the world,” said Zhi Hong, Ph.D., CEO of Brii Bio. “With a shared vision, the collaboration marries the abilities of Tsinghua University and 3rd People’s Hospital of Shenzhen to rapidly discover antibodies against SARS-CoV-2 with Brii Bio’s development expertise in infectious diseases to create an innovative collaboration model and bring the best people together to address the current public health challenge and ones to come.”

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