Pharmanovia In-Licenses Catumaxomab from Lindis Biotech for Malignant Ascites Treatment

BASILDON, UK I November 19, 2024 I Pharmanovia, a global pharmaceutical enterprise known for its innovation in developing new medicines and improving the life cycle of established drugs, has announced the expansion of its oncology portfolio with a new licensing agreement for catumaxomab, an innovative treatment for malignant ascites.

The agreement grants Pharmanovia exclusive rights to bring catumaxomab to market. Catumaxomab is a pioneering, trifunctional bi-specific monoclonal antibody aimed at the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who have no further options for systemic anticancer therapy. Malignant ascites, an abnormal fluid accumulation in the peritoneal cavity, is commonly associated with advanced-stage cancers.

Dr. Stephen Deacon, Chief Scientific Officer at Pharmanovia, elaborates on the drug's novel approach: "Catumaxomab stands out due to its targeted methodology. This bispecific (anti-EpCAM x anti-CD3) trifunctional antibody merges the attributes of traditional monoclonal antibodies with those of bispecific molecules. It directly binds to tumour cells expressing EpCAM and then boosts the patient's immune system to destroy these tumour cells."

Malignant ascites is a relatively rare but serious condition, most frequently associated with ovarian, pancreatic, and gastric cancers, affecting 20-50% of cases.

Dr. James Burt, Pharmanovia's CEO, emphasized the company's mission: "Our goal is to provide innovative and enhanced medicines to those in need, and this agreement perfectly aligns with this mission. Catumaxomab is a first-in-class medicine that has a critical role in cancer supportive care. Although it was previously approved, it is currently unavailable. Through our partnership with Lindis Biotech, we aim to reintroduce catumaxomab to the market, subject to regulatory approval. We are eager to leverage our capabilities in New Chemical Entities (NCEs) to make this important medicine available to patients."

Dr. Horst Lindhofer, CEO of Lindis Biotech, expressed his enthusiasm: "We are thrilled to collaborate with Pharmanovia to commercialize catumaxomab in Europe. Both companies are committed to the significant impact this therapy can have on patients suffering from this challenging condition. Pharmanovia's focus on supportive care, extensive European platform, and expertise in oncology make them the perfect partner. We look forward to a successful partnership while continuing to expand our pipeline for other high-need indications, such as bladder cancer."

Prof. Carsten Bokemeyer, Director of the Department of Medical Oncology and Hematology at the University of Hamburg, UKE, acknowledged the current challenges in treating malignant ascites: "Managing malignant ascites in a clinical setting remains problematic. There are no widely accepted, evidence-based treatment guidelines or specific management recommendations. Progress has been limited in easing the burden on patients and improving their quality of life. Thus, catumaxomab's availability as a targeted therapy is a significant benefit. It reduces the need for punctures, enhances quality of life, and may even improve life expectancy in some cases."

Catumaxomab received a favorable opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in October 2024. If approved, it will become the only drug specifically approved for the treatment of malignant ascites.

Pharmanovia is dedicated to making medicines fit for tomorrow to improve patient lives globally. The company redistributes, repurposes, or re-engineers established medicines and brings novel medicines to market, focusing on high-quality, ethical, and sustainable solutions across endocrinology, neurology, cardiovascular, and oncology therapeutic areas.

Lindis Biotech is committed to developing Triomab® antibodies, a new class of T-cell engaging trifunctional antibodies that enable the immune system to manage and possibly cure malignant cancers.