On May 7, 2019 Clover Biopharmaceuticals, a biotechnology company focused on developing novel and transformative biologic therapies, reported it has received Clinical Trial Application (CTA) approval from the Chinese National Medical Products Administration (NMPA) to conduct clinical trials in China with SCB-313, an investigational fully-human TRAIL-Trimer fusion protein, for the treatment of cancer patients with intracavitary malignancies (Press release, Clover Biopharmaceuticals, MAY 7, 2019, View Source [SID1234535854]). A phase I clinical trial for malignant ascites is planned to initiate in China this year.
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"We are delighted to receive this clearance, as it further validates Clover’s innovative and proprietary Trimer-Tag© technology, in-house R&D capabilities and biomanufacturing expertise," said Dr. Peng Liang, co-founder, Chairman and President of Clover. "We are extremely excited to initiate clinical trials for SCB-313 in China. The treatment of malignant ascites remains a high unmet need globally, with no targeted or biologic antitumor therapies currently approved and available, and we hope that SCB-313 will provide a safe and efficacious option for patients in China and worldwide."
"We believe that SCB-313 has the potential to be a first-in-class and best-in-class TRAIL-based therapy based on our preclinical results to date. 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."