On January 29, 2018 Lee’s Pharm and Sorrento Therapeutics reported that the Chinese authorities have approved China Oncology Focus Limited (COF, an affiliate of Lee’s Pharmaceutical Holdings Limited, Hong Kong Stock Symbol: 0950.HK) to proceed with the clinical trials for ZKAB001, an anti-PD-L1 monoclonal antibody exclusively licensed to COF for Greater China territories, by Sorrento Therapeutics (Press release, Sorrento Therapeutics, JAN 29, 2018, View Source [SID1234532254]).
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The investigation sites will be:
Beijing Cancer Hospital
The Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Wuhan Union Hospital
Shanghai Sixth People’s Hospital
The trials will be anticipated to use a 3+3 design with 5mg/kg, 10mg/kg and 15mg/kg dosing regimens. Once the Maximum Tolerated Dose (MTD) has been established, additional patients are expected to be recruited in an expanded Phase 1 protocol. Clinical data from these studies could be available by the end of the year 2019, and positive results could lead to conditional approval of the antibody prior to a confirmatory Phase 3 study.
"We are proud to announce the acceptance of the IND for our anti-PD-L1 antibody ZKAB001. It’s further evidence for COF continued commitment to addressing high unmet oncology needs by bringing new effective immuno-oncology therapies to the Chinese market. Throughout the IND-enabling activities and the extensive IND review process by the Chinese FDA, the COF team has worked closely and efficiently with Sorrento colleagues. In the landscape of anti-PD-L1 therapies in China, we believe our program is part of the first wave of immune checkpoint inhibitors. Encouraged by our impressive preclinical data, we are excited about evaluating our immunotherapy and addressing unmet medical needs of cancer patients in the Greater China region. Based on this highly productive first joint project, we look forward to potentially expanding our partnership with Sorrento," said Dr. Xiaoyi (Benjamin) Li, Chief Executive Officer and Executive Director of COF.
"We believe COF’s progress in the development of cancer therapeutics for the Greater China market utilizing our G-MAB library of fully human antibodies is a testimony of the value of Sorrento’s comprehensive portfolio of immuno-oncology platform technologies and products acquired and developed over the years," stated Dr. Henry Ji, Chairman and CEO. "Although our own internal resources are currently focused on the development of CAR-T platforms and programs, we think we have shown success in collaborations and out-licensing of other therapeutic assets to a number of strategic partners. COF’s success in developing ZKAB001 could lead to milestone and royalty payments to Sorrento."
About ZKAB001 (anti-PD-L1 monoclonal antibody)
ZKAB001 is a fully human anti-PD-L1 monoclonal antibody (mAb), an immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, then suppressing the inhibition of PD-1/PDL1 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 potentially further strengthening the anti-tumor effect of the antibody. It was licensed from Sorrento Therapeutics, Inc. (SRNE) to COF in Q4 2014.