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

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, for the
treatment of cancer patients with malignant ascites.

“We are extremely excited about the initiation of the SCB-313 study for
malignant ascites. This milestone marks the successful and complete
transition of Clover into a global, clinical-stage biotechnology
company,” said Joshua Liang, Chief Strategy Officer and Board Director
at Clover. “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 worldwide.”

The Phase I, open-label, dose escalation, multi-center trial in
Australia 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 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,” said Dr. Peng Liang, co-founder, Chairman and President of
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. As our first drug
candidate utilizing Trimer-Tag© technology to enter human
clinical trials, SCB-313 is yet another validation of our translational
research capabilities, and we look forward to advancing our other
promising biological candidates in the months ahead.”

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.

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