BEIJING – In one of the latest Sino-foreign collaborations formed to find a cure for the pandemic that has infected 3.5 million people worldwide, Shanghai-based Junshi Biosciences Co. Ltd. and Eli Lilly and Co. have disclosed an agreement to co-develop therapeutic antibodies for preventing and treating COVID-19.
Under the terms, Junshi grants Lilly an exclusive license, outside of greater China, to conduct R&D, manufacture and distribute the SARS-CoV-2 JS-016 neutralizing antibodies developed by Junshi. Lilly will pay $10 million up front and milestone payments of up to $245 million for a particular derivative neutralizing antibody or combination of derivative antibodies corresponding to the same product, as well as double-digit royalties on the net sales of the product.
The U.S. company also undertakes to subscribe to $75 million of Junshi’s shares if certain conditions are met. Financial terms aside, both companies agreed to collaborate in the research, development and commercialization of products relating to these neutralizing antibodies.
“We’ve already started our collaborative work,” Junshi CEO Ning Li told BioWorld. “Lilly will take over the U.S. part and advance [JS-016] to the clinic in June, while we handle the work in greater China ourselves.”
JS-016 is a recombinant fully human monoclonal neutralizing antibody that is specific to the SARS-CoV-2 surface spike protein receptor binding domain. It can effectively block the binding of viruses to host cell surface receptor ACE2.
As reported in March, Junshi worked closely with the Institute of Microbiology of the Chinese Academy of Sciences (IMCAS) to develop JS-016. The two had obtained multiple strains of neutralizing antibodies that can effectively block viral invasion in laboratory assays and had conducted animal experiments. The immuno-oncology firm was verifying the preclinical toxicology and in vivo activity of the antibodies.
Li told BioWorld in March that the company is preparing for an IND for the neutralizing antibodies with domestic and overseas regulatory agencies, including the FDA. On Monday, Junshi revealed plans to submit the IND and initiate clinical studies in the U.S. in the second quarter this year and push it into the clinic in China as soon as possible.
“By leveraging Lilly's global presence and capabilities, we have the potential to reach broader COVID-19 patient populations in a wider range of countries and regions,” said Li in a statement on May 4.
The company stressed its speediness in developing the therapeutic. In the space of two months, Junshi has completed IND-enabling preclinical studies, the process development and production for GLP toxicity study, and GMP production of clinical material with its platform technology.
Earlier, the company said that preliminary in vitro and in vivo studies have verified the blocking activity of the neutralizing antibody strains. It used its antibody development platform to carry out screening for various pathogen host receptors and anti-pathogen antibodies from patients who recovered from COVID-19.
Its Chinese partner, IMCAS, also has a pathogen immunity development platform and has acquired the technical know-how related to the coronavirus. IMCAS has five national key laboratories, the largest fungarium in Asia with nearly 520,000 specimens and the largest common microbial strain collection and management center with nearly 61,000 strains in China.
“The data generated by Junshi suggest the lead antibody may have appropriate properties to support testing its therapeutic use in patients as well as exploring its potential for preventing infection in at-risk individuals,” said Daniel Skovronsky, Lilly's chief scientific officer and president of Lilly Research Laboratories.
The Junshi-Lilly partnership is one of the latest examples of Sino-foreign joint efforts in tackling the pandemic over the past few months.
China, U.S. and the Netherlands-based Harbour Biomed Therapeutics Ltd. is helping Dutch researchers find a monoclonal antibody that prevents SARS-CoV-2 virus from infecting cultured cells. Meanwhile, it is working to combine its H2L2 Harbour Mice platform for fully human monoclonal antibody generation with U.S.-based Mount Sinai Health System’s translational medical research expertise to find novel biotherapies to treat cancer and COVID-19.
Beijing-based Beigene Ltd. has formed a collaboration with Atreca Inc. and IGM Biosciences Inc. by contributing its global clinical trial team to help discover and develop engineered immunoglobulin IgM and IgA antibodies targeting SARS-CoV-2.
Chengdu-based Clover Biopharmaceuticals Inc. is teaming up with Emeryville, Calif.-based Dynavax Technologies Corp. in a research collaboration to develop a COVID-19 vaccine candidate, known as COVID-19 S-Trimer.
Shanghai’s Fosun Pharmaceutical Co. Ltd. is collaborating with Mainz, Germany-based Biontech SE to develop and commercialize a COVID-19 mRNA prevention vaccine.
Other partnerships that have been made public include a vaccine candidate being co-developed by Inovio Pharmaceuticals Inc. and Beijing Advaccine Biotechnology Co., as well as SARS-CoV-2-targeting human monoclonal antibodies co-developed by Wuxi Biologics and Vir Biotechnology Inc.