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Clover Biopharmaceuticals Receives NMPA Approval for SCB-313 (TRAIL-Trimer) to Initiate Clinical Trials in China

2019年05月07日 PM10:00
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CHENGDU, China

Clover Biopharmaceuticals, a biotechnology company focused on developing novel and transformative biologic therapies, today announced 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. A phase I clinical trial for malignant ascites is planned to initiate in China this year.

“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.”

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190507005611/en/

CONTACT

Clover Biopharmaceuticals
Joshua Liang, +86 028-85336966
joshua.liang@cloverbiopharma.com

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