Pharmanovia, a global pharmaceutical company focused on commercializing innovative medicines and revitalizing established ones, today announced the expansion of its oncology portfolio with a new licensing agreement for catumaxomab. This agreement will enable the treatment of malignant ascites, a rare and serious condition.
Pharmanovia, a global pharmaceutical company focused on revitalizing and advancing established medicines, today announced the expansion of its oncology portfolio through a licensing agreement with Lindis Biotech for catumaxomab, a treatment for malignant ascites.
Catumaxomab is a trifunctional bispecific monoclonal antibody designed for the intraperitoneal treatment of malignant ascites in adults with epithelial cell adhesion molecule (EpCAM)-positive cancers who are not candidates for further systemic therapy. Malignant ascites is an abnormal fluid buildup in the abdominal cavity often caused by advanced cancer.
Dr. Stephen Deacon, Chief Scientific Officer, explained: “Catumaxomab’s novel targeted approach is exciting. This bispecific (anti-EpCAM x anti-CD3) trifunctional antibody combines the characteristics of traditional monoclonal antibodies with bispecific molecules. It binds to EpCAM-expressing tumor cells and enhances the immune system’s ability to kill these cells.”
Malignant ascites occurs most frequently in ovarian, pancreatic, and stomach cancers, affecting 20 to 50% of patients with advanced disease.
Dr. James Burt, CEO of Pharmanovia, stated: “This partnership exemplifies our mission to bring innovative treatments to patients. Catumaxomab is a first-in-class therapy that has the potential to play a crucial role in cancer supportive care. Through this collaboration with Lindis Biotech, we aim to reintroduce this promising treatment to the market, pending regulatory approval. We are eager to leverage our expertise in bringing novel medicines to patients.”
Dr. Horst Lindhofer, CEO of Lindis Biotech, added: “We’re thrilled to partner with Pharmanovia to commercialize catumaxomab in Europe. Both companies are committed to making this transformative therapy available to as many patients as possible. Pharmanovia’s strong oncology expertise and broad European platform make them the ideal partner for this important mission.”
Professor Carsten Bokemeyer, Director of Medical Oncology and Hematology at the University of Hamburg, noted: “Malignant ascites treatment remains a major challenge, with few evidence-based treatment guidelines. The availability of catumaxomab, a tumor-targeted therapy, provides clear benefits by reducing the need for punctures and improving patients’ quality of life, and in some cases, even their life expectancy.”
Catumaxomab received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in October 2024, with expected EU marketing authorization by the end of 2024. If approved, it will be the only drug specifically approved for the cancer-targeted treatment of malignant ascites.
About Pharmanovia
Pharmanovia is a global healthcare company dedicated to the lifecycle management of medicines. Our goal is to future-proof therapies that improve patient outcomes. We focus on rediscovering, repurposing, or developing new medicines in key therapeutic areas such as endocrinology, neurology, cardiovascular disease, and oncology.
About Lindis Biotech
Lindis Biotech is a clinical-stage biopharmaceutical company focused on developing Triomab® antibodies, a new class of bispecific trifunctional antibodies that target T cells to fight malignant cancers.
About Catumaxomab
Originally approved in the EU in 2009 under the brand name Removab, catumaxomab was the first drug specifically approved for the treatment of malignant ascites. It binds to both EpCAM and CD3 antigens, forming a bridge between cancer cells and T cells, enhancing the body’s immune response to destroy cancer cells. The drug was withdrawn from the EU market in 2017 for commercial reasons but has demonstrated its safety and effectiveness in over 2,000 patients. It is now poised for reapproval under the brand name KORJUNY®.
