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 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. The manufacturing is expected to begin later 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 with 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 is the preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our unparalleled breadth of offerings enables our customers to commercialize their discoveries and innovations in the healthcare industry.
Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately 16,000 full-time employees, we comprise high-performing teams and individual talent that make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 5.4 billion with a CORE EBITDA of CHF 1.7 billion in Full-Year 2021.
About Oasmia Pharmaceutical AB
Oasmia is a specialty pharmaceutical company focused on the development of new therapeutic options for patients suffering from hard-to-treat cancers. It has a growing pipeline of clinical-stage assets targeting late-stage cancers. Apealea® (paclitaxel micellar) is being made available to ovarian cancer patients through a partnership with Elevar Therapeutics, Inc. Development programs include Cantrixil, in clinical development for late-stage ovarian cancer, and docetaxel micellar, in development for advanced prostate cancer. Oasmia has proprietary drug delivery technology designed to improve solubility, efficacy and safety.