Partnership between Bora Pharmaceuticals and TaiRx, Inc. for anticancer drug manufacturing

A partnership between Bora Pharmaceuticals and TaiRx, Inc. is expected to support the manufacturing of breakthrough anticancer drug CVM-1118, with two phase II clinical trials to commence.

The small molecule therapeutic is a novel chemical entity developed by TaiRx Inc. as an anticancer agent for numerous human cancer cell lines. The drug boasts a strong anticancer activity profile, along with a high safety margin and multiple mechanisms of action when targeting cancer-specific factors. CVM-1118 utilises a novel mechanism involving the inhibition of vasculogenic mimicry, a structure associated with metastasis and drug-induced resistance in malignant tumours. In a phase I study by the US FDA, the safety of oral administration of CVM-1118 was demonstrated and obtained approval for the commencement of two phase II clinical trials by the US FDA and Taiwan FDA.  

Bora Pharmaceuticals, an international CDMO specialising in complex oral solid dosages and other modes of administration, will provide sites for the manufacturing of the phase II clinical trial batches, with submission to the NDA for approval. CEO of Bora Pharmaceuticals Bobby Sheng commented on the partnership: “We are extremely excited about this new partnership with TaiRx. As a trusted global pharmaceutical partner, we look forward [to] providing many of our technical and quality resources to TaiRx and supporting them on this important project.” 

Du-Shieng Chien, President and CEO of TaiRx Inc. Further added: “As we enter the second stage of clinical trials, we hope our success continues and we hope to gain approval from the NDA for CVM-1118 in the near future.” 

The partnership comes on the heels of Bora Pharmaceuticals acquisition of a USD $100 million Biologics site in Taiwan as part of a 5-year plan to grow and develop. Such investment is aimed at increasing Bora Pharmaceuticals’ capabilities in biologics manufacturing and to provide customer support with high-quality manufacturing facilities for innovative pharmaceutical products.