On February 22, 2019 Elpiscience Biopharma, Ltd. reported that the bispecific antibody ES101 has been approved by the Center for Drug Evaluation (CDE) for clinical trials in China (Press release, Elpiscience, FEB 22, 2019, View Source;id=1311 [SID1234536920]). ES101 is a first-in-class, bispecific antibody targeting both PD-L1 and 4-1BB, where 4-1BB-induced T cell activation is dependent on the binding to PD-L1 in the tumor microenvironment. The combination of "de-brake" and "add-gas" ideas not only greatly improved the efficacy of the drug, but also avoided the toxicity that 4-1BB single agent may have. This would solve the problem that 4-1BB monoclonal antibodies have encountered in clinical development. In the mean time, on February 19th, Inhibrx, Elpiscience’s US partner of ES101, announced the dosing of first patient of ES101 in the US. With ES101 being tested in clinical trials both in China and the US, it is expected to benefit cancer patients worldwide.

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Dr. Darren Ji, CEO of Elpiscience, said: "ES101 represents the arrival of the next generation of cancer immunotherapy beyond PD-1/PD-L1. As a first-in-class bispecific antibody, ES101 is expected to bring a transformative treatment to cancer patients on top of the existing therapies. We are delighted to witness this historical moment, which would have marked a small step for Elpiscience and its partner, and a giant leap for patients."

About ES101

ES101 is a tetravalent bispecific antibody that contains four binding domains, two targeting PD-L1 and two targeting 4-1BB, with a molecular weight being only two-thirds of that of an conventional antibody. Based on the high expression of PD-L1 in the tumor microenvironment and an unique antibody engineering, ES101 can conditionally activate 4-1BB upon binding to PD-L1. This would allow for a more efficient tumor killing by immune cells.