Published On: Tue, Apr 20th, 2021

Transcenta gets US FDA clearance for launching phase 1 trial of TST005

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has secured clearance of its investigational new drug (IND) application for TST005 from the US Food and Drug Administration (FDA) for launching a phase I clinical trial of the bi-functional anti-PD-L1/TGF-β antibody.

According to the Chinese clinical stage biotherapeutics company, TST005 is a bi-functional anti-PD-L1 and TGF-β trap fusion protein that has been designed to a couple of immuno-suppressive pathways simultaneously by transforming growth factor -β (TGF-β) and programmed cell death ligand-1 (PD-L1), that are widely used by cancer cells to escape from the immune system.

TST005 is said to contain a high affinity PD-L1 antibody that is fused with a modified TGF-β Receptor Type II protein in its C-terminal, said Transcenta.

As it lacks FcR binding activity, TST005 can reduce FcR mediated killing of PD-L1 expressing effector .

Transcenta gets US FDA clearance for launching phase 1 trial of TST005

Transcenta gets clearance for launching phase 1 trial of TST005. Photo courtesy of The U.S. Food and Drug Administration/

Dr. Michael Shi – Transcenta EVP, Head of Global R&D and CMO, said: “We plan to simultaneously develop TST005 both in China and the United States under the same Phase I protocol with an innovative basket trial design.

“With the IND Clearance for TST005 in the US, we will accelerate the clinical development globally by allowing Chinese dosed at the current dose level when joining the study upon Chinese IND clearance.

“Once safety and tolerability are established, we plan to further evaluate TST005 in multiple other pretreated tumor types globally, benefiting patients worldwide at an early date.”

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