Under the agreement, Lonza will deliver cGMP-standard drug substance for clinical supply
The collaboration is projected to take Cantrixil through the planned Phase II clinical trial
Manufacturing to begin in March 2022 at Lonza's HPAPI manufacturing laboratories in Nansha, China
Solna, Sweden and Basel, Switzerland, 21 March 2022 - Oasmia Pharmaceutical AB, an oncology-focused specialty pharmaceutical company, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, announced today that the companies have signed a large-scale manufacturing agreement for the main drug intermediate in the supply of clinical material for its investigational drug candidate, Cantrixil.
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 successfully completed a Phase I trial. Ovarian cancer is one of the most aggressive cancers and is difficult to treat in advanced stages. The Phase I study of Cantrixil 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.
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. Manufacturing is expected to begin in March 2022.
Kai Wilkinson, Chief Technical Officer at Oasmia, commented:"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, added: "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."
Lonza Group Ltd. published this content on 21 March 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 21 March 2022 06:07:05 UTC.