TaiRx, Inc. (6580) announces good news at the start of 2019 that it receives “Technology and Product or Technology Development is Successful and Marketable” recommendation from the Industrial Development Bureau, bringing TaiRx one step closer to its IPO goal. TaiRx also successfully initiated two Phase II clinical trials for its CVM-1118 anticancer compound. 2019 is looking to be a fruitful year for TaiRx.
The recommendation from the Industrial Development Bureau is the government’s effort to support companies with potential and promising performance allowing biotech and pharmaceutical companies to IPO under the “science and technology” categorization. Companies will have to first go through a round of rigorous assessment by the Ministry of Economic Affairs for its competitiveness, marketability, development resources, product pipeline, and operational stability before receiving this recommendation. For a new drug development company, this is a stamp of recognition by the government for its development effort.
TaiRx’s main product in development, a small molecule anticancer agent, CVM-1118, also started its Phase II multi-center clinical trial in Taiwan and the United States, which is also another important milestone for the company. CVM-1118 is a new generation multi-target anticancer agent with unique capability of inhibiting vasculogenic mimicry formation. Vasculogenic mimicry is a new cancer metastatic mechanism. In addition to the commonly known angiogenesis, vasculogenic mimicry allows the cancer cell to form blood vessel-like structure without vascular cells. The formation of vasculogenic mimicry is a result of an aberration gene expression from malignant tumor allowing the cells to form vascular structure and connected to blood vessels allowing tumor to receive nutrition and metastasize. As a result, recent clinical practices have suggested the inhibition of both endothelial-guided angiogenesis and non-endothelial cell-formed vasculogenic mimicry be the best strategy to stop tumor growth, providing a novel development target for new anticancer drug.
TaiRx has received the approval for the International Nonproprietary Names of Foslinanib for CVM-1118 by WHO. This is the first chemical compound developed in Taiwan to receive such approval. After the completion of its Phase I clinical trials, TaiRx will target Neuroendocrine Tumor and Hepatocellular Carcinoma for Phase II clinical trials of CVM-1118 in Taiwan and the United States. The reason behind these two indications is due to its limited selection and effectiveness of the treatment options available to late stage patients. CVM-1118 will target these two indications first and expand to additional indications in the future.
In addition to the major development CVM-1118, TaiRx’s sepsis adjuvant treatment agent, Rexis®, continues its clinical trial in seven clinical centers in Taiwan. Zelnite® for the prevention and treatment of selenium deficiency has also received NDA approval in January 2018 and officially on market by the end of 2018. TaiRx is now a new drug development company with product on the market.
To expand TaiRx’s international reach, TaiRx has established subsidiaries in both Maryland, United States, and Kunshan, China. This will allow TaiRx to establish its product manufacturing and market in China and at the same time push its antibody drug development in the United States and TaiRx to international pharmaceutical companies in order to open up the possibility of global or regional licensing and compete in the global pharmaceutical market.