CHENGDU, China--(BUSINESS WIRE)--Clover Biopharmaceuticals, a global clinical-stage biotechnology company focused on developing novel and transformative biologic therapies, today announced 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). 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).
“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.”
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 Pleural Effusions (MPE)
MPE is the abnormal accumulation of fluid in the pleural cavity in cancer patients, indicating intrapleural dissemination of cancer cells and is typically a grave prognostic sign. Almost all MPE is associated with dyspnea (shortness of breath) due to the obstruction of lung expansion. Worldwide chemical pleurodesis, utilizing sclerosing agents such as talc, is often performed to manage MPE, but often results in chest pain and has a high failure rate. Pleural aspiration and/or insertion of an indwelling pleural catheter (IPC) for ambulatory MPE drainage are alternative treatment modalities. None of these methods treat the underlying tumor cells, and all have potential risks and recognized complications. Currently, there are no targeted or biologic antitumor therapies approved to reduce production or prevent re-accumulation of MPE. Most often occurring in patients with lung cancer (but also occurring in other malignancies such as breast cancer, lymphoma/hematological malignancies, gastrointestinal cancers, etc.), MPE remains a major unmet medical need worldwide.