The first in China!

On June 7, the new drug clinical trial application (IND) of the antibody-conjugated drug MRG004A that targets tissue factor (TF) submitted by Shanghai Miac, a wholly-owned subsidiary of Lepu Bio, was accepted by CDE

Tissue factor is a transmembrane protein involved in blood coagulation, but abnormally high expression of TF has been found in a variety of tumors

The results of immunohistochemical staining reported in a series of papers showed that TF is positively expressed in a variety of solid tumors, such as cervical cancer with a positive rate of 100%, non-small cell lung cancer at 34%~88%, and endometrial cancer at 14%~ 100%, prostate cancer 47%~75%, ovarian cancer 75%~100%, esophageal cancer 43%~91%, bladder cancer 78%[1]

Globally, there are relatively few new drug projects under development for the target of TF, and there are only 3 TF ADC drugs under development.

TF ADC drugs under development worldwide

Source: NextPharma database

Unlike the traditional coupling technology used by tisotumab vedotin through the interchain thiol group, MRG004A is an innovative ADC developed by Lepu Bio/Miyaco based on the GlycoConnectTM fixed-point coupling technology imported from Synaffix and the HydraSpaceTM polar spacer technology.

This technology has precise control of the coupling site, can reduce the risk of drug shedding in the blood circulation and toxicity, and has a wider treatment window

In pre-clinical studies, MRG004A has shown significant anti-tumor activity in multiple animal models of pancreatic cancer and ovarian cancer carrying Kras G12V mutations, showing good clinical application potential

Source: Lepu Biotech Prospectus

The first indication for the fastest TF ADC drug Tisotumab vedotin is cervical cancer.

In view of the good safety data and therapeutic potential of MRG004A in preclinical studies, it is also expected that the TF ADC drugs developed by Chinese companies can obtain excellent data in subsequent clinical development

Reference

[1].