BRII-196/BRII-198 Monoclonal Antibody Description
BRII-196 and BRII-198 are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients.
The monoclonal antibodies have been specifically engineered to reduce the risk of antibody-dependent enhancement and prolong the plasma half-lives for potentially more durable treatment effect. In addition, their non-overlapping epitope binding regions provide a high degree of neutralization activity against the SARS-CoV-2 betacoronavirus.
The combination of BRII-196/BRII-198 was generally safe and well-tolerated in Phase 1 studies. In addition to the collaboration with NIAID, Brii Biosciences is conducting additional studies in China, evaluating the pharmacokinetics and safety of combination BRII-196/BRII-198 and a Phase 2 efficacy study of combination BRII-196/BRII-198 for the treatment of COVID-19.
The Company confirmed investigational New Drug applications had been submitted for the combination therapy to the U.S. Food and Drug Administration, the China National Medical Products Administration, and the Department of Health in Hong Kong, China.
Brii Bio (stock code: 2137. HK) is a multi-national company based in DURHAM, N.C., United States, and BEIJING, China, developing innovative therapies for diseases with significant unmet medical needs large public health burdens. Brii Biosciences Limited has been included as a constituent stock of the Hang Seng Composite Index. October 2021 corporate presentation. For more information, visit www.briibio.com. Ob Dec. 5, 2021, Brii Biosciences Limited was added to the Hong Kong Stock Connect.
BRII-196/BRII-198 Monoclonal Antibody History
In early 2020, the Company partnered with Tsinghua University and Shenzhen Third People’s Hospital to establish TSB Therapeutics for the development of BRII-196 and BRII-198.
BRII-196/BRII-198 Monoclonal Antibody Indication
BRII-196/BRII-198 Monoclonal Antibody is indicated to treat non-hospitalized COVID-19 patients at high risk of clinical progression.
BRII-196/BRII-198 Monoclonal Antibody Variant Effectiveness
The ACTIV-2 study dataset includes participants enrolled in the United States, Brazil, South Africa, Mexico, Argentina, and the Philippines between January and July of 2021 – a period of the global emergence of novel SARS-CoV-2 variants. Data on the clinical efficacy of combination BRII-196/BRII-198 by variant type will also be evaluated as part of the study. Current in vitro pseudovirus testing data suggests that combination BRII-196/BRII-198 retains activity against major SARS-CoV-2 variants of concern, including the following commonly identified variants, B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.429 (Epsilon), B.1.617.2 (Delta), and C.37 (Lambda).
BRII-196/BRII-198 Monoclonal Antibody News
November 25, 2021 - Local media reported: How a Chinese Covid-19 drug was created in an instant – after years in the making.
November 17, 2021 - Brii Biosciences Limited announced it has received the "R&D Achievement of the Year" Award, sponsored by BayHelix, at the 2021 BioCentury China Healthcare Summit in Shanghai, China. The recognition is for the R&D achievements of Brii Bio's investigational monoclonal neutralizing antibody combination therapy, BRII-196/BRII-198 for the treatment of COVID-19.
October 8, 2021 - Brii Biosciences Limited announced the filing of an emergency use authorization application for its investigational SARS-CoV-2 combination monoclonal antibody therapy, BRII-196/BRII-198, with the U.S. FDA.
October 3, 2021 - Brii Biosciences Limited presented interim results from Phase 3 of the ACTIV-2 trial, which showed that BRII-196/BRII-198 (“combination BRII-196/BRII-198”), the Company’s neutralizing monoclonal antibody (mAb) combination therapy for the SARS-CoV-2 coronavirus, achieved a similar reduction in hospitalization or death among patients who initiated treatment early (within five days) versus late (six to 10 days) following symptom onset. These initial results suggest that combination BRII-196/BRII-198 may remain effective in a majority of patients who are late to treatment, potentially extending its clinical benefit in a real-world setting, where rapid access to care can be a challenge.
September 7, 2021 - Brii Biosciences Limited announced that the Company is committing an additional US$100 million to advance global regulatory filings and commercial efforts for its investigational SARS-CoV-2 combination therapy BRII-196/BRII-198.
August 24, 2021 - Brii Biosciences Limited announced that its SARS-CoV-2 neutralizing monoclonal antibody combination therapy, BRII-196/BRII-198, demonstrated a statistically significant reduction of 78%, relative risk in the combined endpoint of hospitalization and death compared with placebo in 837 non-hospitalized COVID-19 patients at high risk of clinical progression.
July 20, 2021 - Brii Biosciences Initiates Phase 2 Clinical Trial in China for Neutralizing Antibodies, BRII-196, and BRII-198.
BRII-196/BRII-198 Monoclonal Antibody Clinical Trials
Clinical Trial NCT04787211 - The aim of this phase 2 study is to evaluate the safety and efficacy of single-dose IV infusion of BRII-196 and BRII-198 given as combination therapy in patients with severe COVID-19 and mild to moderate COVID-19 and asymptomatic carrier.