TaiRx, a biotech company listed on the emerging stock market, announced on the 17th that its anti-cancer drug CVM-1118 has completed Phase 2a clinical trials for the treatment of neuroendocrine tumors (NET) and advanced liver cancer. The company is now moving forward with Phase 2b clinical trials. The pancreatic neuroendocrine tumor indication has been granted orphan drug status by the US FDA, which will provide seven years of market exclusivity upon the drug’s approval.

In addition to its new drug development, TaiRx’s selenium injection product, Zelnite®, has recently signed a partnership agreement with Taiwan Biotech to help promote Zelnite® in Japan and Southeast Asia. The product is expected to receive drug approval in Japan by the second half of next year, with potential approval in Malaysia by the end of next year.

TaiRx’s Chairman Andrew Lin stated that the company plans to launch a new round of capital increases in the second half of this year and will apply for a technology industry certification, aiming to complete its public listing by next year.

TaiRx’s General Manager Du-Shieng Chien mentioned that CVM-1118 has completed its initial Phase 2 clinical trial for treating neuroendocrine tumors (NET). Preclinical animal studies confirmed that CVM-1118 effectively reduced pancreatic neuroendocrine tumors (PNET) in mice. Based on these results, TaiRx applied for orphan drug designation from the US FDA and received approval. This designation will grant seven years of market exclusivity upon approval, and the drug will be exempt from expensive new drug application fees. It will also have priority review qualifications, which could expedite the approval process.

TaiRx is now in discussions with the US FDA regarding the next phase of the Phase 2b clinical trial for CVM-1118 and will plan the trial’s design based on the FDA’s feedback, which will also facilitate negotiations with partners for multinational, multi-center trial collaborations.

Additionally, early results from a clinical trial in Taiwan on the combination of CVM-1118 and the immune drug Nivolumab as second-line treatment for advanced liver cancer show a trend toward better efficacy compared to monotherapy with immune treatment. This has attracted interest from Chinese pharmaceutical companies, which are seeking to collaborate on combining CVM-1118 with their immune drug for first-line treatment in the Chinese liver cancer market.

TaiRx has begun preparing for an application for clinical trials in China and will consult with the Chinese FDA regarding the design of the immune combination treatment. The company has also presented its research findings on CVM-1118 to leading liver cancer experts in China, who have expressed strong support and agreed to assist in advancing clinical trials in the mainland.

Resource: 台睿癌藥獲美FDA孤兒藥資格 硒注射劑將進軍日本及大馬