On March 11, 2019 Yuhan Corporation (000100.KS; Yuhan) and Sorrento Therapeutics, Inc. (Nasdaq: SRNE) announced today that ImmuneOncia, a joint venture formed in September 2016, has completed the Phase 1 study of IMC-001 (also known as STI-3031), a fully human anti-PD-L1 monoclonal antibody (mAb) immune checkpoint inhibitor (Press release, Sorrento Therapeutics, MAR 11, 2019, View Source [SID1234534199]).
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This Phase 1 dose-escalation study, approved by the South Korean Ministry of Food and Drug Safety (MFDS) in February of 2018, enrolled subjects with locally-advanced or metastatic solid tumors at Seoul National University Hospital (SNUH) and Samsung Medical Center (SMC). The Recommended Phase 2 Dose (RP2D) was determined to be successful with no observations of dose-limiting toxicities. More results of this study will be disseminated at upcoming conferences.
"Based on the results of the Phase 1 trial of IMC-001, we are planning on conducting a Phase 2 trial to evaluate its efficacy in rare cancers in the second half of this year," stated Yun Jeong Song, CEO of ImmuneOncia. "Moreover, we greatly appreciate those who supported us and for their contributions as the company successfully completed a Phase 1 trial of IMC-001. In collaboration with various institutions, we will continue our research and development of IMC-001 as well as the additional checkpoint immune-oncology molecules in our pipeline."
About IMC-001 (PD-L1 monoclonal antibody)
IMC-001 is a fully human anti-PD-L1 monoclonal antibody immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, suppressing the inhibitory signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting natural killer (NK) cells and other effector cells against the tumor and potentially further strengthening the anti-tumor effect of the antibody. The clinical-grade material of IMC-001 was manufactured by Sorrento in its San Diego-based GMP antibody production facility.