The trials will be anticipated to use a 3+3 design with 5mg/kg, 10mg/kg and 15mg/kg dosing regimens. O
HONG KONG and SAN DIEGO, Jan. 29, 2018 (GLOBE NEWSWIRE) -- Effective January 29th, 2018, Lee’s Pharma and Sorrento Therapeutics announce 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.
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.
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
About China Oncology Focus Limited (“COF”)
COF is an affiliate of Lee’s Pharmaceutical Holdings Limited and is a drug development company specialized in oncology disease area. COF is currently developing three assets, namely PD-L1, TG02 and Glufosfamide. PD-L1 is a human monoclonal antibody against programmed cell death 1 ligand 1 and its development is to help cancer patient’s own immune system to fight the disease. TG02 is a unique, oral multi-kinase inhibitor and its development will initially focus on the treatment of glioblastoma and hepatocellular carcinoma. Glufosfamide is a third-generation alkylating agent designed for greater specificity and tumor uptake, with reduced systemic toxicities and side effects. It is currently being evaluated in a pivotal Phase 3 international randomized trial, for the second-line treatment of patients with pancreatic cancer. China’s part is expected to be initiated by 1H of 2018.
About Lee’s Pharmaceutical Holdings Ltd. (“Lee’s Pharm”)
Lee’s Pharmaceutical Holdings Limited is a research-based, biopharmaceutical company listed in Hong Kong with over 20 years of operation in China’s pharmaceutical industry. It is fully integrated with solid infrastructures in drug development, clinical development, regulatory, manufacturing, sales and marketing in China with global perspectives and currently markets 15 products in China. Lee’s Pharm focuses on several different areas such as cardiovascular and infectious diseases, dermatology, oncology, gynecology, ophthalmology and others. It has more than 30 products under different development stages stemming from both internal R&D as well as from the recent acquisition of licensing and distribution rights from various US, European and Japanese companies. The mission of Lee’s Pharm is to become a successful biopharmaceutical group in Asia providing innovative products to fight diseases and improve health and quality of life. Additional information is available at http://www.leespharm.com
Forward-Looking Statements
This press release contains forward-looking statements related to Sorrento Therapeutics, Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward looking statements include statements regarding the developments of and prospects for ZKAB001; Sorrento’s products and technologies, including its antibody products and technologies; Sorrento’s ability to leverage the expertise of its employees, subsidiaries, affiliates and partners to assist the company in the execution of its strategies; outcome of the data from a clinical trial for ZKAB001; Sorrento’s M&A and licensing strategy; Sorrento’s and its partners’ abilities to accelerate the development of any lead programs in the clinic; and expectations for Sorrento’s and its subsidiaries’ technologies and product candidates. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento’s, its subsidiaries’ and partners’ technologies and prospects; risks that ZKAB001 may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks related to seeking regulatory approvals and conducting clinical trials; and other matters that are described in Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2016, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
ZTlido™ and G-MAB™ are trademarks owned by Scilex Pharmaceuticals, Inc. and Sorrento, respectively.
Seprehvir®, is a registered trademark of Virttu Biologics Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and part of the group of companies owned by Sorrento Therapeutics, Inc.
All other trademarks are the property of their respective owners.
© 2018 Sorrento Therapeutics, Inc. All Rights Reserved.
Media and Investor Relations Contact of COF: Dr. Benjamin Li (CEO) Telephone: 852.2314.1282 Email: Website: http://www.leespharm.com Contact of Sorrento: Alexis Nahama, DVM (VP Corporate Development) Telephone: 1.858.203.4120 Email: Website: www.sorrentotherapeutics.com
