Pharmanovia has announced a licensing agreement with Lindis Biotech for catumaxomab, a first-in-class, trifunctional bi-specific monoclonal antibody, to treat malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas who are ineligible for further systemic anticancer therapy. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on catumaxomab in October 2024, potentially making it the only approved drug for this indication.
Malignant ascites, characterized by abnormal fluid accumulation in the peritoneal cavity, commonly arises from advanced-stage cancers, particularly ovarian, pancreatic, and gastric cancers, with an incidence rate between 20% and 50% of all cases. Current management strategies lack specific, evidence-based guidelines, leaving a significant unmet need for effective therapies.
Novel Targeted Approach of Catumaxomab
Dr. Stephen Deacon, Chief Scientific Officer of Pharmanovia, highlighted the unique mechanism of catumaxomab, stating, “What is exciting about catumaxomab is that it has a novel targeted approach. This bispecific (anti-EpCAM x anti-CD3) trifunctional antibody combines the characteristics of classical monoclonal antibodies and bispecific molecules. It binds directly to the tumour cells expressing EpCAM and then enhances the activation of the patient’s own immune system resulting in the killing of tumour cells.”
Catumaxomab functions by binding to both EpCAM on tumor cells and CD3 on T-cells, forming a bridge that facilitates T-cell-mediated killing of cancer cells. Additionally, it activates Fc-gamma receptor-positive immune cells, such as monocytes and macrophages, further enhancing the body's immune response and potentially inducing a vaccination effect.
Addressing Unmet Needs in Malignant Ascites
Pharmanovia CEO, Dr. James Burt, emphasized the company's mission, stating, “Our mission is to bring innovative and improved medicines to patients who need them, and this deal is the epitome of this. We have a first-in-class medicine, that can play a critical role in cancer supportive care that has previously been approved but is no longer available. We’re looking to change that through this partnership with Lindis Biotech, reintroducing catumaxomab to the market, subject to full regulatory approval.”
Dr. Horst Lindhofer, CEO of Lindis Biotech, added, “We are excited to partner with Pharmanovia to support the commercialisation of catumaxomab in Europe. Both companies share a firm belief in the profound impact this therapy can have on the lives of patients facing this devastating condition and uphold a steadfast commitment to making catumaxomab available to as many people as possible.”
Clinical Perspective
Prof. Carsten Bokemeyer, Director of the Department of Medical Oncology and Hematology at the University of Hamburg, UKE, noted the challenges in managing malignant ascites: “The clinical management of malignant ascites remains a distressing problem in the medical field. Unfortunately, to this day, no generally accepted, evidence-based treatment guidelines or specific management recommendations for MA exist and there has been little progress to ease the burden for patients and improve their quality of life. Thus, the availability of catumaxomab as a specific tumour-directed therapy is a clear benefit for patients in this difficult situation. Catumaxomab reduces the need for punctures, improves quality of life, and even seems to improve life expectancy in a number of cases.”
Catumaxomab was previously granted marketing authorization in the EU in 2009 but was withdrawn in 2017 due to commercial reasons. The anticipated EU marketing authorization is expected by the end of 2024, under the brand name KORJUNY®.
