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

CHENGDU, China–(BUSINESS WIRE)–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.

Contacts

Clover Biopharmaceuticals
Joshua Liang, +86 028-85336966
[email protected]