2 October 2019 - - 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, Chinese biotechnology company Clover Biopharmaceuticals said.

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).

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.

Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercialising transformative biologic therapies, with a focus on oncology and autoimmune diseases.

Clover is utilising its proprietary Trimer-Tag technology platform to develop novel biologics targeting trimerization-dependent pathways.

Trimer-Tag is an innovative drug development platform which allows the production of novel, covalently-trimerised fusion proteins.

Many major disease targets are trimerisation-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 trimerised fusion proteins that are able to effectively target these previously undruggable pathways.

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 utilised 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.