02 September 2020 | News
Phase 1 and Phase 1/2 Clinical Trials Expected to Begin Enrolling Healthy Subjects and Patients with Mild to Moderate COVID-19 by early October
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The global company BeiGene, Ltd. and Beijing based Singlomics (Beijing DanXu) Biopharmaceuticals Co., Ltd., have 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 (Abs), 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.
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.