The CDMO will provide kilogram-scale synthesis, purification, and stability testing for Oasmia’s drug candidate
Oasmia Pharmaceutical, an oncology-focused specialty company, has signed a large-scale manufacturing agreement with Lonza for the main drug intermediate in the supply of clinical material for its investigational drug candidate, Cantrixil.
The candidate is an intraperitoneally administered drug in development for the treatment of late-stage ovarian cancer. A Phase I study demonstrated the potential for the ingredient to provide prolonged survival in advanced ovarian cancer by inducing ovarian cancer stem cells’ death and sensitising cancer cells to standard chemotherapy. Oasmia is now preparing for the initiation of a Phase II trial in advanced ovarian cancer.
Through the agreement, Lonza will provide kilogram-scale synthesis, purification, and stability testing, and also deliver cGMP batches of drug substance for clinical supply. The drug substance will be manufactured at Lonza’s recently expanded production facility at Nansha, China. Manufacturing is expected to begin in March 2022.
Kai Wilkinson, Chief Technical Officer at Oasmia, said: “We are excited to have partnered with Lonza, a global leader in drug manufacturing. The manufacture of Cantrixil is planned to be performed in three steps and this agreement is the first and most crucial step in us securing the clinical drug supply for its development.”
Christian Dowdeswell, VP and Global Head, Commercial Development – Small Molecules, Lonza, said: “Our team has extensive experience supporting the development and manufacture of challenging molecules. We are looking forward to collaborating with Oasmia to advance this promising drug candidate in the clinic.”
Image copyright: Lonza Ltd