Clover Biopharmaceuticals Doses First Patient in Phase I Study of SCB-313 in China for Peritoneal Carcinomatosis

BEIJING

Clover Biopharmaceuticals, a 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 China for the treatment of cancer patients with peritoneal carcinomatosis.

“Peritoneal carcinomatosis 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 peritoneal carcinomatosis.” said Dr. Yan Li, Director of Department of Peritoneal Surgical Oncology at Beijing Shijitan Hospital 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 peritoneal carcinomatosis.

“Since China has the largest global incidence of gastrointestinal cancers, which often cause peritoneal carcinomatosis, we are extremely excited about the initiation of the SCB-313 study in China. Now that SCB-313 has successfully initiated clinical studies evaluating SCB-313 in multiple countries, Clover hopes to bring this novel and potentially first-in-class therapy to patients worldwide,” said Dr. Min Dong, Executive Vice President, Global Clinical Development at 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,” 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 Peritoneal Carcinomatosis
Peritoneal carcinomatosis (PC) is a locoregional disease defined as tumor dissemination inside the peritoneal cavity and is typically a grave prognostic sign; PC often stems from gastrointestinal tumors but may also arise from primary peritoneal cancers as well as pseudomyxoma peritonei and peritoneal mesothelioma. When possible, cytoreductive surgery (CRS) to remove peritoneal tumors combined with hyperthermic intraperitoneal chemotherapy (HIPEC) and intraperitoneal/systemic chemotherapy have remained the most frequently utilized treatment modalities; however, many patients are unresectable, and high rates of recurrence or incomplete CRS leave many patients with no treatment options. Currently, there are no targeted or biologic antitumor therapies approved to treat PC, and thus, PC remains a major unmet medical need worldwide.

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