BeiGene, Ltd. and Singlomics (Beijing DanXu) Biopharmaceuticals Co., Ltd., today announced that the companies have executed an exclusive license agreement for BeiGene to develop, manufacture and commercialize globally outside of greater China Singlomics’ investigational anti-COVID-19 antibodies, including DXP-593 and DXP-604. Utilizing high-throughput single-cell sequencing of convalescent blood samples from recovered patients with COVID-19, Singlomics has identified multiple antibodies that have been shown to be highly potent in pre-clinical studies in neutralizing SARS-CoV-2, the virus that causes COVID-19.
“Our goal was to find highly potent neutralizing antibodies as quickly as possible in order to develop a potential treatment that can be scaled to treat more patients than convalescent plasma therapy can provide,” said Sunney Xie, Lee Shau-Kee Chair Professor of Peking University, Director of Beijing Advanced Innovation Center for Genomics (ICG), and Co-Founder and Chairman of the Scientific Advisory Board at Singlomics.
“By collaborating with BeiGene, we are confident that these important scientific advancements are in good hands for the next stage of their development, as BeiGene has a strong global clinical development organization with a team of more than 1,300 people as well as the reach and drive to bring innovative treatments to the people who need them,” said Janet Xu Zhang, Ph.D., Co-Founder and CEO at Singlomics.
“Dr. Xie has made an important contribution to our understanding of COVID-19, utilizing single cell genomics to find potentially human neutralizing antibodies,” said Lai Wang, Ph.D., Senior Vice President, Head of Global Research, Clinical Operations & Biometrics and APAC Clinical Development, at BeiGene. “We are looking forward to initiating clinical trials for this exciting program and to contribute to the worldwide efforts in developing novel treatments for patients with COVID-19.”
A Phase 1 randomized, double-blind, and placebo-controlled clinical trial is expected to begin enrolling up to 30 healthy subjects in Australia in September. The Phase 1/2 multinational trial in patients with mild to moderate COVID-19 is also expected to begin enrollment by early October. More information on the trials will be available on www.clinicaltrials.gov.
Under the terms of the agreement, Singlomics has granted BeiGene exclusive rights in ex-China territory to develop, manufacture, and commercialize its preclinical assets DXP-593 and DXP-604, as well as for a series of antibody sequences that could target the COVID-19 virus. BeiGene plans to develop one or more of these antibodies globally outside of greater China, while Singlomics will retain rights in greater China. Singlomics will receive an upfront payment and be eligible to receive payments upon the achievement of regulatory and commercial milestones. Singlomics will also be eligible to receive tiered royalties, up to double-digits, on future product sales.
About DXP-593 and DXP-604
DXP-593 and DXP-604 are SARS-CoV-2 neutralizing antibody drug candidates identified by high-throughput single-cell RNA and VDJ sequencing of antigen-enriched B cells from over 60 convalescent patients. DXP-593 has exhibited strong neutralization potency in preclinical testing, with an IC50 of 1.2 ng/mL and 15 ng/mL against pseudotyped and authentic SARS-CoV-2, respectively. It displayed strong therapeutic and prophylactic efficacy in SARS-CoV-2-infected rodent models. DXP-604 binds to a different epitope from DXP-593, also with demonstrated high potency. DXP-593 and DXP-604 can potentially be used as a cocktail treatment option that could avoid resistance due to viral mutation.
Source – BusinessWire