BeiGene Announces an Exclusive License Agreement on Neutralizing Antibodies against SARS-CoV-2 Developed by Singlomics
Phase 1 and 1/2 clinical trials are expected to be initiated by early October this year to enroll healthy subjects and patients with mild to moderate symptoms of COVID-19 infections, respectively.
On August 27, 2020, BeiGene (NASDAQ: BGNE; HKEX: 06160) and Singlomics Biopharmaceuticals Co., Ltd. announced they have entered into an exclusive license agreement. BeiGene will further develop, manufacture, and commercialize neutralizing antibodies against SARS-CoV-2 (including DXP-593 and DXP-604) under development by Singlomics globally, but outside Greater China. In preclinical studies, Singlomics have screened out several potent neutralizing antibodies against SARS-CoV-2 from blood samples of convalescent COVID-19 patients by using the high-throughput single-cell sequencing technology.
Academician Xiaoliang Xie, Lee Shau-kee Chair Professor of Peking University, Director of Beijing Advanced Innovation Center for Genomics, and Co-founder & Chairman of the Scientific Advisory Board of Singlomics, said: "Our goal is to find potent neutralizing antibodies against SARS-CoV-2 as quick as possible. We aim to develop a potential treatment regimen which can greatly benefit broader patient populations than those treated by the convalescent plasma therapy."
Dr. Xu Zhang, Co-founder and CEO of Singlomics, said: "We believe that working with BeiGene can effectively push these significant scientific achievements into the next stage of development. BeiGene’s global clinical development team of more than 1,300 employees has the ability to reach out around the world to bring innovative therapies to patients in need."
Dr. Lai Wang, Senior Vice President of BeiGene, Head of Global Research, Clinical Operations & Biostatistics and Head of Asia-Pacific Clinical Development, commented: "Professor Xiaoliang Xie has made a major breakthrough in the study of antibodies against SARS-CoV-2, and has screened out antibodies expected to neutralize
SARS-CoV-2 by using the high-throughput single-cell sequencing technology. We are pleased to be able to initiate a clinical trial for this exciting drug candidates and to contribute to the development of novel therapies for the global fight against COVID-19 epidemic."
A randomized, double-blind, placebo-controlled Phase 1 clinical trial is expected to be initiated in Australia in September, enrolling up to 30 healthy subjects, while Phase 1/2 clinical trials to be conducted in multiple countries will be initiated by early October to enrol patients with mild to moderate symptoms of COVID-19 infections. Information on both clinical trials will be published on clinicaltrials.gov.
Under the terms of the Agreement, Singlomics has authorized BeiGene exclusive rights to develop, manufacture, and commercialize its preclinical drug candidates DXP-593, DXP-604, and other neutralizing antibodies against SARS-CoV-2 outside Greater China. BeiGene plans to develop one or more drug candidates globally outside Greater China, while Singlomics will retain relevant rights in Greater China. Singlomics will receive an upfront payment from BeiGene and be eligible to receive payment after the latter reaching the registration and milestone of commercialization. In addition, Singlomics will be eligible to receive graded royalties from BeiGene’s sales of the future products at a two-digit percentage ratio.
About DXP-593 and DXP-604
DXP-593 and DXP-604 are two neutralizing antibodies against SARS-CoV-2, screened from the memory B cells specific for the viral spike protein harvested from more than 60 convalescent COVID-19 patients. The antibody discovery was accomplished by using the high-throughput single-cell transcriptome and VDJ sequencing technologies. In biological assays, DXP-593 demonstrated strong neutralizing activity against SARS-CoV-2 pseudoviruses and live viruses, with half maximal inhibitory concentration (IC50) measured as 1.2 ng/ml and 15 ng/ml, respectively. In rodent models infected with SARS-CoV-2, DXP-593 also showed a strong curative and preventive effect. The binding epitope of DXP604 is different from that of DXP593, and it also showed distinctly neutralizing activity. The pairing of DXP593 and DXP604 are expected to be a highly competitive cocktail therapeutic option for the treatment of COVID-19 infections, especially in combatting drug resistance caused by viral mutations.
About Singlomics
Singlomics Biopharmaceuticals Co., Ltd. is a biotechnology company committed to using single-cell sequencing technology platforms to research and develop antibody drugs, and to promoting the discovery of innovative medicine for the treatment of difficult human diseases including infectious as well as autoimmune diseases. Singlomics is preparing to build an antibody drug production base in Changping District, Beijing, and has completed the first round of financing from China's medical and health investors with a focus on expanding its product portfolio and enhancing manufacturing capabilities.
About BeiGene
BeiGene is a global, commercial-stage biotechnology company focused on the research, development, manufacturing, and commercialization of innovative drugs to improve treatment outcomes and broaden the access of drugs for patients worldwide. It currently has over 4,200 employees in mainland China, the United States, Australia and Europe and is accelerating the diversification of its new therapeutic drug pipelines. Currently, two drug products independently developed by BeiGene have been brought to market: a BTK inhibitor Brukinsa® (Zanubrutinib Capsules) sold in the United States and China, and an anti-PD-1 antibody drug Baizean® (Tislelizumab Injection) sold in China. In addition, BeiGene is selling or plans to sell multiple anti-cancer drugs in China, which have been licensed from Amgen, Celgene Logistics, Ltd. (a subsidiary of Bristol Myers Squibb) and EUSA Pharma. For more information, please visit www.beigene.cn.
Forward-looking Statements of BeiGene
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding future development and potential commercialization of licensed drug candidates, potential payments to Singlomics, potentials for licensed drug candidates, mutual commitments and potential benefits of cooperations. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory authorities, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development & commercialization of its drug candidates and achieve and maintain profitability; the impact of the COVID-19 pandemic on the BeiGene’s clinical development, regulatory, commercial, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.
