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On July 20, TOP-2 ADC of Toyo Pharmaceutical was approved for clinical use

As a new type of antibody drug, ADC has gradually attracted the attention of all parties in recent years, and the number of development has exploded, and it is inevitable that it has encountered the phenomenon of clustering popular targets

TROP-2 target

TROP-2, human trophoblast cell surface glycoprotein antigen 2, also known as tumor-associated calcium signal transducer 2 (TACSTD2), is a cell surface glycoprotein encoded and expressed by the Tacstd2 gene in the 1p32 region of chromosome

Compared with normal tissue cells, TROP-2 is up-regulated in a variety of malignant tumor cells and is also an important tumor development factor.

Currently, radioimmunotherapy targeting TROP-2, antibody drugs combined with traditional chemotherapy, chemotherapeutic therapy, and antibody-conjugated drugs are rapidly developing and gradually applied in clinical research, especially ADC drugs

Figure 1 Trop2-mediated apoptosis/proliferation signaling pathway and reducing tumor cell adhesion/promoting invasion and metastasis

(Image source: Chin Med Biotechnol, August 2018, Vol.

TROP-2 Domestic R&D Status

According to the Insight database, a total of 5 domestic companies are currently developing Trop-2 ADC

From the Insight database (http://db.

Gosartuzumab that became famous in World War I

Sacituzumab govitecan (IMMU-132) is a First-in-class TROP-2 ADC developed by Immunomedics abroad, and its trade name is Trodelvy

Trodelvy has been making great progress from clinical to market

In China, Genting Xinyao completed the first layout on the TROP-2 track by introducing this product in 2019, with a transaction amount of US$835 million

Figure 4.

(Image source: https:// first echelon in China: Kelun, Junshi

Among the domestic ADC products targeted by TROP-2, there are a total of 3 products that have entered the clinic

The other two products with the same target are from Kelun Botai and Duoxi/Junshi

SKB-264 Project Time Axis (Insight)

The development company of DAC-002 is Hangzhou Duoxi Biologics, which is an ADC drug of anti-Trop2 monoclonal antibody coupled with anti-tubulin Tubulysin B analogues through a smart linker.

JS108 project time axis (Insight)

Latecomers: Dongyao Pharmaceutical, Fudan Zhangjiang

The FDA018 of Fudan Zhangjiang and the recombinant humanized anti-Trop2 monoclonal antibody-SN38 conjugate of Toyo Pharmaceuticals/Shijian Biotechnology were newly applied for clinical application in April and May of this year, and have now been approved for clinical use

In addition, many domestic companies are deploying Trop-2, including CSPC, Hausen Pharmaceutical, Luoqi Biological, Qide Pharmaceutical and other companies have published antibody patents, and Henlius has also introduced a Trop-2.
Antibody
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