Lindis Biotech and Pharmanovia Obtain EU Approval for Catumaxomab for Malignant Ascites

MUNICH, Germany, and BASILDON, UK, February 13, 2025 – LINDIS Biotech GmbH, a company in the clinical stage of developing biopharmaceuticals, and Pharmanovia, a global entity in the pharmaceutical sector, have announced a groundbreaking development in cancer treatment. The European Commission (EC) has approved catumaxomab, marking it as the sole drug authorized for the treatment of malignant ascites (MA) in Europe. This condition, which is a severe complication of advanced cancer, involves fluid buildup in the abdomen, leading to symptoms like abdominal distension, pain, and fatigue, significantly affecting the quality of life.

Under a licensing agreement, LINDIS Biotech has granted exclusive rights to Pharmanovia for marketing and launching catumaxomab throughout Europe. This drug is a first-in-class therapeutic primarily aimed at adults with malignant ascites due to epithelial cellular adhesion molecule (EpCAM)-positive carcinomas who cannot undergo other systemic anticancer treatments.

Stephen Deacon, the Chief Scientific Officer at Pharmanovia, emphasized the importance of this approval, noting its potential to enhance the lives of those suffering from malignant ascites. Catumaxomab leverages the patient's immune system to fight cancer cells, providing a novel treatment strategy for this debilitating condition.

Pharmanovia's CEO, Dr. James Burt, discussed the broader impact of this approval, reinforcing Pharmanovia's dedication to innovation in the pharmaceutical sector. He highlighted that the authorization of catumaxomab not only offers a crucial treatment for malignant ascites but also strengthens Pharmanovia's stature in delivering essential medications.

Dr. Horst Lindhofer, CEO of LINDIS Biotech, expressed enthusiasm about the marketing approval, underscoring its potential to tackle significant medical challenges associated with malignant ascites. He pointed out that patients often endure invasive procedures like paracentesis, which comes with risks and impacts their quality of life. Partnering with Pharmanovia ensures that this innovative therapy reaches all eligible patients.

Catumaxomab operates by targeting and linking cancer cells and T-cells, enabling the immune system to attack and destroy cancer cells. It binds to EpCAM, a common marker in many carcinomas, and CD3 antigens, forming a bridge that facilitates the immune response. Additionally, it engages other immune cells to enhance the body’s defense against cancer.

The history of catumaxomab adds an interesting layer to this achievement. Initially authorized under the brand name Removab in the EU in 2009, its marketing was halted in 2014 due to commercial reasons, and it was withdrawn in 2017. Despite these challenges, LINDIS Biotech's continued development led to a favorable opinion from the Committee for Medicinal Products for Human Use (CHMP), and it was reintroduced under the brand name KORJUNY®.

This development is promising for targeting EpCAM-positive carcinomas, including gastric, colorectal, ovarian, and other cancer types. The specific targeting of the EpCAM marker, prevalent in various carcinomas and cancer stem cells, offers a strategic approach to potentially reducing metastasis and improving patient outcomes.

In summary, the marketing authorization of catumaxomab represents a significant advancement in treating malignant ascites, offering hope to patients across Europe. LINDIS Biotech and Pharmanovia's collaboration ensures that this innovative therapy will become a vital option in the cancer treatment landscape.