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Eli Lilly and Junshi Biosciences have made a deal to jointly develop therapeutic antibodies for the possible prevention and treatment of COVID-19. Multiple antibodies have been developed, with the best one to enter clinical testing in the coming months. The disease currently sweeping the globe is caused by the SARS-CoV-2 novel coronavirus.
Junshi Biosciences is a China-based biopharmaceutical company specializing in the commercial development of novel drug therapies.
At the outset of the COVID-19 pandemic, Junshi launched one of the industry’s first research and development projects aimed at developing unique therapies to defeat COVID-19. Junshi has engineered a few neutralizing antibodies, with the most promising ones poised for clinical testing very soon.
“Since the outbreak of the novel coronavirus, we’ve been working around the clock to fight against the pandemic. Entering into this deal with Eli Lilly enables us to speed up the clinical development of Junshi SARS-CoV-2 antibodies on a global basis,” said Ning Li, Junshi Biosciences’ chief executive officer of commercialization. “By leveraging Eli Lilly’s global capabilities and presence, we now have the potential to reach a broader COVID-19 patient base in a wider range of regions and countries.”
Lilly’s chief scientific officer and president of Lilly Research Laboratories, Daniel Skovronsky said, “As the number of global Covid-19 cases continues to increase, there is a critical need to study more than one complementary approaches to the disease. The data from Junshi Biosciences suggests the leading antibody may have good properties to allow testing its therapeutic use in patients. Likewise, we can explore its potential for preventing future infection in at-risk people. We look forward to partnering with Junshi Biosciences to quickly begin testing these new potential therapies in clinical trials.”
As part of the deal, Eli Lilly will receive an exclusive license to carry out the clinical development, manufacturing, and distribution of the resulting products in countries outside of China. Junshi Biosciences will maintain all rights in China.
Junshi’s JS016 is a unique, fully human recombinant monoclonal neutralizing antibody that specifically targets the SARS-CoV-2 surface spike protein receptor-binding domain. It can effectively block the virus from binding to the surface of the host cell receptor ACE2. The development of this is a joint project between Junshi Biosciences and the Institute of Microbiology at the Chinese Academy of Science.
At the outset of the COVID-19 pandemic, Junshi Biosciences quickly launched the research program to develop neutralizing antibodies to defeat COVID-19. In under two months, Junshi had completed IND facultative pre-clinical studies. Likewise, they achieved the process development and production for a GLP toxicity study. Finally, GMP production of clinical material was leveraged with the company’s technology platform.
Lilly and Junshi Biosciences seek to submit an IND application and begin clinical studies in the U.S. in the coming months. In the meantime, the company is in constant communication with the Center for Drug Evaluation of the National Medical Products Administration to begin the IND application process in China as soon as possible.
Eli Lilly has also partnered with AbCellera Biologics to develop antibodies to prevent and treat Covid-19.
The partnership will combine Lilly’s antibody development, manufacturing, and distribution capability with AbCellera’s rapid pandemic response platform.
After a week of receiving blood samples from a recovered Covid-19 patient, AbCellera was able to screen more than five million immune cells, identifying the ones that produced antibodies.
Subject to agreement with the National Institute of Allergy and Infectious Diseases, the antibodies’ ability to neutralize the virus will be assessed.
Under this agreement, Lilly and AbCellera will share equally the initial cost of development for a final product.
After that, Lilly will proceed with further development, as well as manufacturing and distribution. If successful, Lilly will also obtain the necessary regulatory approvals.
Daniel Skovronsky, Eli Lilly chief scientific officer said, “With the number of cases quickly growing all over the globe, doctors and patients are looking for a therapeutic drug that can speed their recovery or even prevent the disease. We are moving as fast as we can to create a treatment to help Covid-19 patients. While a new therapeutic antibody typically takes years to get into the clinic, our goal with AbCellera is to test a potential new drug in patients within the next few months.”