NEMOD Immuntherapie AG Presents Promising Biodistribution Data for PankoMab™ in Mice

Berlin, 17.6.2003. NEMOD Immuntherapie AG, a drug discovery company focusing on oncological indications, today presented promising preclinical biodistribution data for the systemic delivery of the company’s proprietary PankoMab™ antibody targeting the TA-MUC-1 antigen. In her report, Dr. Renate Stahn, Director, Preclinical Development, NEMOD, showed that PankoMab™ coupled to the radionuclide 111Indium accumulates strongly and specifically in colon and breast carcinomas implanted in mice.

“We are extremely encouraged by the results of these studies, and have already initiated negotiations about a Phase I biodistribution study in late stage cancer patients following from the report presented by Dr. Stahn”, said Dr. Andreas Hey, COO of NEMOD. “The preclinical work reported on by Dr. Stahn and her team demonstrates the versatility and power of the PankoMab™ platform in delivering cell toxins, in this case supporting the feasibility of systemic radioimmunotherapy”. The preclinical study reported on in the oral presentation by Dr. Stahn, entitled “Biodistribution of 111Indium in Xenograft Mice”, was designed to investigate biodistribution of the radionuclide 111Indium in mice xenografted with tumor implants. Using various dosing regimes, infusions of antibodies chelated to 111Indium were administered. After infusion radioactivity was measured in blood collected as well as biodistribution of 111Indium in the liver, lung, kidney, heart, brain, and bone over 72 h.

No embolization or adverse clinical signs were associated with this procedure. Antibody uptake by the tumor was rapid and specific whereas radiation burden in other organs was low (e.g. 5% of the injected dose per gram in the liver). Radioactivity measured in organs on various days post-dosing showed that the majority of the 111Indium was localized in the tumor, with uptake rates (injected dose per gram) after 72 hours exceeding 80%. Importantly, PankoMab™ showed no binding to shedded MUC-1, a finding consistent with the data from in-vitro studies of sera from gastro-intestinal cancer patients. The study suggests the feasibility of radioimmunotherapy using PankoMab™ and provides the foundation for additional investigations.

NEMOD Immuntherapie AG is a drug discovery company affiliated with publicly listed Eckert & Ziegler Strahlen- und Medizintechnik AG (ISIN DE 0005659700, German Prime Standard) and dedicated to the development and commercialization of its proprietary PankoMab™ technology. Prime foci are oncological indications like gastric, colon, liver, and breast cancer. MUC-1 (“human epithelial mucin ”) is a well known, widely expressed protein of normal epithelial cells. A variation of MUC- 1, TA-MUC-1, is a carbohydrate-induced conformational antigen that can only be found on epithelial tumors including colon, gastric, pancreatic, prostate, lung, and breast cancer. The monoclonal antibody PankoMab™ has been shown to have very high affinity to the TA-MUC-1 molecule in preclinical development as well as high ADCC capacities. ADCC – Antibody-Dependent Cellular Cytotoxicity – is the mechanism by which antibodies induce natural killer cells and other effector cells of the patients’ immune system to destroy the tumor cell.

The Board of Directors