BeiGene has entered into an exclusive licence agreement with Singlomics (Beijing DanXu) Biopharmaceuticals for neutralising Covid-19 antibodies.
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Under the deal, BeiGene will develop, manufacture and commercialise Singlomics’ investigational anti-Covid-19 antibodies, including DXP-593 and DXP-604, across the globe except for Greater China.
By using single-cell sequencing of convalescent blood samples from recovered Covid-19 patients, Singlomics has detected multiple antibodies that were demonstrated to be potent in pre-clinical studies in neutralising SARS-CoV-2.
In September, a phase 1 randomised, double-blind, and placebo-controlled clinical study that enrols up to 30 healthy subjects in Australia is expected to be commenced.
The phase 1/2 multinational study in patients with mild to moderate Covid-19 is also expected to commence recruitment by early October.
DXP-593 has demonstrated strong neutralisation potency in preclinical testing against pseudotyped and authentic SARS-CoV-2, while the DXP-604 that binds to a different epitope from DXP-593 also showed high potency.
BeiGene global research, clinical operations and biometrics and APAC clinical development head and senior vice president Dr Lai Wang said: “We are looking forward to initiating clinical trials for this exciting programme and to contribute to the worldwide efforts in developing novel treatments for patients with Covid-19.”
As per terms of the agreement, BeiGene has secured exclusive rights from Singlomics for DXP-593 and DXP-604 preclinical assets in ex-China territory, as well as a series of antibody sequences that can target the Covid-19 virus.
BeiGene intends to develop one or more of these antibodies globally outside of greater China. Singlomics will hold rights in Greater China.
Singlomics will secure an upfront payment, as well as eligible to secure payments based on the achievement of regulatory and commercial milestones.
The deal also includes the payment of tiered royalties up to double-digits to Singlomics on future product sales.
Singlomics founder and CEO Dr Janet Xu Zhang said: “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 organisation 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.”
In January this year, Amgen completed the acquisition of a 20.5% stake in BeiGene for approximately $2.8bn to support the expansion of its oncology footprint in China.