The companies have signed a large-scale manufacturing agreement for the main drug intermediate in the supply of clinical material for Oasmia’s investigational drug candidate, Cantrixil.
“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,” says Kai Wilkinson, Chief Technical Officer at Oasmia.
Treatment of late-stage ovarian cancer
Cantrixil, an intraperitoneally administered drug in development for the treatment of late-stage ovarian cancer, was licensed by Oasmia from the Australian pharmaceutical company Kazia in 2021, having completed a Phase I trial. The Phase I study demonstrated the potential for it to provide prolonged survival in advanced ovarian cancer by inducing ovarian cancer stem cells’ death and sensitizing cancer cells to standard chemotherapy.
Oasmia is now preparing for the initiation of a Phase II trial of Cantrixil in advanced ovarian cancer.
Manufacturing will begin in March 2022
Under the terms of the agreement, Lonza will provide kilogram-scale synthesis, purification, and stability testing of Cantrixil, and deliver cGMP batches of drug substance for clinical supply. Oasmia will leverage Lonza’s extensive experience and expertise in manufacturing highly-potent API (HPAPI). The drug substance will be manufactured at Lonza’s recently expanded production facility at Nansha, China. The manufacturing is expected to begin later in March 2022.
Photo of Kai Wilkinson: Oasmia