26 September 2022 | News
Further seeking approval for Ph II trials of the novel anticancer drug
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Bora Pharmaceutical Laboratories Inc. (Zhunan), a division of Bora Pharmaceuticals has partnered with TaiRx, Inc., a Taiwan new drug development company, to manufacture a novel anticancer drug, CVM-1118.
CVM-1118 is a new small molecule chemical entity being developed by TaiRx as a potential anti-cancer agent in numerous human cancer cell lines with strong anti-cancer activity, high safety margin, and multiple mechanisms of actions in targeting cancer-specific factors.
In particular, CVM-1118 possesses the novel mechanism of inhibiting a unique structure known as vasculogenic mimicry (VM), which is associated with metastasis and drug-induced resistance in malignant tumors. The safety of orally administering CVM-1118 on a human is evaluated from the phase 1 study US FDA. Based on results of the Phase I clinical studies, CVM-1118 obtained the approval to conduct two Phase II clinical trials by both the US FDA and Taiwan FDA.
The manufactured batches will be used to further support Phase II clinical trials and then submitted to the NDA for approval.
Bora Pharmaceuticals recently announced that it acquired a $100 million Biologics site in Taiwan as part of its 5-year growth plan. The investment enables Bora Pharmaceuticals to significantly expand its capabilities in the Biologics space, which will allow its customers to gain access to high-quality manufacturing facilities for their new and innovative pharmaceutical products.