China Oncology Focus Limited Receives Approval by Chinese Authorities to Begin Clinical Trials in Three Separate Cancer Indications Using Sorrento’s Anti-PD-L1 Monoclonal Antibody
HONG KONG and SAN DIEGO,
The investigation sites will be:
- Beijing Cancer Hospital
The Cancer Instituteand 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
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento's multimodal multipronged approach to fighting cancer is made possible by its’ extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”), intracellular targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Seprehvir®”).
Sorrento's commitment to life-enhancing therapies for cancer patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule in Resiniferatoxin (“RTX”) and ZTlido. Resiniferatoxin is completing a Phase 1b trial in terminal cancer patients. ZTlido is in regulatory review following NDA re-submission.
For more information visit www.sorrentotherapeutics.com
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Media and Investor Relations Contact of COF: Dr. Benjamin Li (CEO) Telephone: 852.2314.1282 Email: email@example.com Website: http://www.leespharm.com Contact of Sorrento: Alexis Nahama, DVM (
VP Corporate Development) Telephone: 1.858.203.4120 Email: firstname.lastname@example.org Website: www.sorrentotherapeutics.com
Source: Sorrento Therapeutics, Inc.