Clover Biopharmaceuticals Doses First Patient in Phase I Study of SCB-313 in China for Malignant Ascites

CHENGDU, China

Clover Biopharmaceuticals, a biotechnology company focused on developing novel and transformative biologic therapies, today announced 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. 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).

“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.”

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; moreover, the continuous accumulation of ascites often leads to rapid loss of nutrients, causing severe hypoalbuminemia. 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.

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