“We are extremely excited about the initiation of the SCB-313 study for malignant ascites. This milestone marks the successful and complete transition of Clover into a global, clinical-stage biotechnology company,” said Joshua Liang, Chief Strategy Officer and Board Director at Clover. “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 worldwide.”
The Phase I, open-label, dose escalation, multi-center trial in Australia 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 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,” said Dr. Peng Liang, co-founder, Chairman and President of Clover. “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. As our first drug candidate utilizing Trimer-Tag© technology to enter human clinical trials, SCB-313 is yet another validation of our translational research capabilities, and we look forward to advancing our other promising biological candidates in the months ahead.”
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercializing transformative biologic therapies, with a focus on oncology and autoimmune diseases. Clover is utilizing its proprietary Trimer-Tag© technology platform to develop novel biologics targeting trimerization-dependent pathways. Additionally, Clover is leveraging its in-house cGMP biomanufacturing capabilities to develop select biosimilars. For more information, please visit our website: www.cloverbiopharma.com.
About Trimer-Tag© Technology
Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. Many major disease targets are trimerization-dependent such as the tumor necrosis factor superfamily (involved in extrinsic apoptosis, immune co-stimulation and inflammation) as well as enveloped RNA virus antigens responsible for entry into host cells. Clover is using Trimer-Tag© technology to create trimerized fusion proteins that are able to effectively target these previously undruggable pathways.
About Malignant Ascites
Malignant ascites is the abnormal accumulation of fluid in the peritoneal cavity in cancer patients, indicating intraperitoneal dissemination of cancer cells and is typically a grave prognostic sign. Repeated paracentesis (peritoneal puncture and drainage of ascites) and diuretics have remained the most frequently utilized treatment modalities for decades but do not treat the underlying tumor cells causing ascites production, and ascitic fluid typically quickly re-accumulates. Currently, there are no targeted or biologic antitumor therapies approved and available to reduce production or prevent re-accumulation of malignant ascites. Often occurring in patients with gastro-intestinal and ovarian primary malignancies, malignant ascites remains a major unmet medical need worldwide.