On September 29, 2019 Clover Biopharmaceuticals, a biotechnology company focused on developing novel and transformative biologic therapies, reported that the first patient was dosed in another Phase I trial of SCB-313, an investigational fully-human TRAIL-Trimer fusion protein, in China for the treatment of cancer patients with malignant ascites (Press release, Clover Biopharmaceuticals, SEP 29, 2019, View Source [SID1234539894]). There are now four 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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"Malignant ascites has historically posed significant challenges for both patients and clinicians, and with no efficacious therapies currently available, it remains a high unmet medical need for many cancer patients worldwide. My team and I look forward to evaluating SCB-313 as a potential new therapy for the treatment of cancer patients with malignant ascites," said Dr. Jin Li, Director of Department of Oncology at Tongji University Shanghai East Hospital, President of the Chinese Society of Clinical Oncology (CSCO) and Principal Investigator of the trial.
The Phase I, open-label, dose escalation trial in China is designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of intraperitoneally administered SCB-313 as a single-agent for the treatment of malignant ascites.
"We are excited to work with world-renowned medical oncologist Dr. Jin Li and his team at Shanghai East Hospital. China has the largest global incidence of gastrointestinal cancers, which often cause malignant ascites, so we look forward to the results from this SCB-313 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."