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Tucidinostat/Chidamide (Trade name in Mandarin :剋必達®, Trade name in English : Kepida®)

Overview Anti-cancer mechanism First indication Second indication

Tucidinostat/Chidamide (Trade name in Mandarin :剋必達®,  Trade name in English : Kepida®)

 

Tucidinostat is a globally recognized novel therapeutic currently being developed by four pharmaceutical companies across various regions. GNT Biotech Hub (GNTbm) secured the exclusive rights for the research, development, manufacturing, and commercialization of Tucidinostat in Taiwan in September 2013.As one of the most promising candidates in the global landscape of HDAC inhibitors, Tucidinostat functions as a subtype-selective histone deacetylase inhibitor (also known as an epigenetic modulator) that specifically targets HDAC isoforms 1, 2, 3, and 10. By blocking the activity of histone deacetylases, the drug facilitates the transition of tightly wound chromatin into a more relaxed structure, thereby reactivating tumor suppressor genes or immune antigen genes previously silenced by cancer cells.Acting as a genomic switch in anti-cancer strategies, Tucidinostat exposes disguised malignant cells to the immune system. It serves as a pivotal epigenetic agent in the conversion of immunologically cold tumors into hot tumors.

Tucidinostat has been approved for four indications globally, and two pivotal Phase III clinical trials for cancer immunotherapy are about to be completed. So far, in the global development of HDAC inhibitors, Tucidinostat is the most approved HDACi for cancer indications, expanding from lymphoma to solid tumors.

Tucidinostat is being actively developed in Taiwan and also by the other three companies around the world for different new indications. Firstly in China, Tucidinostat has obtained drug approvals for three new indications: treatment of relapsed or refractory peripheral T-cell lymphoma (R/R PTCL), HR+/Her-2- advanced breast cancer, and MYC/BCL2 double-expressing DLBCL; in Japan, Tucidinostat has also obtained drug approvals for two new indications: relapsed or refractory adult T-cell lymphoma (R/R ATL) and relapsed or refractory peripheral T-cell lymphoma (R/T PTCL); in the United States, the European Union, and other countries, a pivotal Phase III trial of Tucidinostat combined with Opdivo® for first-line treatment of advanced melanoma has completed patient enrollment in 17 countries worldwide; and in Taiwan, Tucidinostat has obtained the first drug approval for the treatment of HR+/Her-2- advanced breast cancer, and is expanding the second indication for the treatment of relapsed or refractory peripheral T-cell lymphoma (R/R PTCL).

 

Basic Information of Tucidinostat/Kepida®


Tucidinostat Patent Licensing and Development

  After the originator Chipscreen Biosciences completed the global multinational patent layout of Tucidinostat, it  successively licensed the patents to many international new drug development companies and well-known big pharmaceutical companies, and the international licensing and development status is as follows:

In 2006, Chipscreen Biosciences granted patents outside China, Hong Kong and Taiwan to HUYABIO International, LLC.
In 2013, Chipscreen Biosciences authorized Taiwan right to GNTbm.
In 2020, HUYABIO International reauthorizes a total of eight countries, including Japan, Korea and Southeast Asia to Meiji Seika Pharma of Japan.
Tucidinostat is currently developed globally and owned by four pharmaceutical companies, cooperating with each other.


 

 

Table 1. The current status of Tucidinostat clinical development.