On November 21, 2019 Clover Biopharmaceuticals, a global clinical-stage biotechnology company focused on developing novel and transformative biologic therapies, reported that the first patient was dosed in a Phase I trial of SCB-313, an investigational fully-human TRAIL-Trimer fusion protein, in Australia for the treatment of cancer patients with malignant pleural effusions (MPE) (Press release, Clover Biopharmaceuticals, NOV 21, 2019, View Source [SID1234551590]). There are now five clinical studies evaluating SCB-313 open to recruiting patients in China and Australia across three oncology indications (malignant ascites, peritoneal carcinomatosis, and malignant pleural effusions).
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"MPE has historically posed significant challenges for both patients and clinicians, and it remains a high unmet medical need for many cancer patients worldwide," said Dr. Y. C. Gary Lee, Director of Pleural Medicine at Sir Charles Gairdner Hospital, Perth, Australia.
The Phase I, open-label, dose escalation trial in Australia is designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of intrapleural administered SCB-313 for the treatment of MPE. Several sites in Australia, including Dr. Lee’s unit, are participating in this study.
"We are excited to work with these world-class investigators and sites participating in this study," said Dr. Min Dong, Executive Vice President, Global Clinical Development at Clover. "Now that Clover has successfully initiated clinical studies evaluating SCB-313 in multiple countries, we hope to bring this novel and potentially first-in-class therapy to patients worldwide."
"TRAIL has long been considered a tantalizing target for cancer therapy because it can induce apoptosis in a tumor-specific manner across many different tumor types. SCB-313, which utilizes our proprietary Trimer-Tag© technology, is able to potently and uniquely target this trimerization-dependent pathway," said Dr. Peng Liang, co-founder, Chairman and President of Clover. "We believe that SCB-313 has the potential to be a best-in-class TRAIL-based therapy based on our R&D results to date, and in the months ahead, we look forward to initiating multiple new clinical studies for the treatment of intracavitary cancers."