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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
.
MRG004A is one of the few TF ADC drugs in the world that has entered the clinical development stage.
Tissue factor is a transmembrane protein involved in blood coagulation, but abnormally high expression of TF has been found in a variety of tumors
.
Abnormal expression of TF is usually associated with tumor growth, angiogenesis, tumor metastasis, and poor prognosis of clinical treatment.
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.
Currently, only Lepu Bio/Miyaco develops ADCs targeting TF.
Drugs
.
Currently, no drug targeting TF has been approved for marketing in the world.
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.
Drugs
.
This technology has precise control over 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
.
The first indication for the fastest TF ADC drug Tisotumab vedotin is cervical cancer.
Its US marketing application was accepted by the FDA in April this year.
It is suitable for cervical cancer patients who relapse or metastasize during or after chemotherapy
.
The application has obtained the priority review qualification granted by the FDA, and will usher in the FDA's approval decision on October 10, 2021
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].
