Phase 2 clinical trials. Sym001 Rozrolimupab (Sym001), an orphan drug, is a recombinant polyclonal antibody consisting of twenty-five monoclonal antibodies that is being developed for treatment of various hematological diseases such as, Idiopathic Thrombocytopenic Purpura and Hemolytic disease of the newborn. Sym004 Mechanism: Sym004 is a combination of two chimeric monoclonal antibodies (mAB), 992 and 1024, discovered and developed using the Symplex process that inhibits tumor growth in a number of cancerous cell lines including A431NS (A431 cells). When used together, 992 and 1024 cross link epidermal growth factor receptor (EGFR) and the EGFR is rapidly internalized and undergoes degradation. Alone, these mAbs are unable to effectively induce degradation of EGFR and inhibit tumor growth. mAb 992 and 1024 are thought to work synergistically. The antibodies bind to different epitopes on the EGFR and their cooperation shows a statistically significant improvement on tumor growth inhibition over non-synergistic use of the antibodies. Alone, Sym004 has been shown to be more potent than Cetuximab, a monoclonal antibody used to block ligands from accessing the EGFR, because Sym004 induces removal of the receptor from the cell surface. Sym004 also inhibits tumor cell growth because removal of the EGFR prevents it from cooperating with other receptors and signaling molecules in the tumor cell. Clinical Results: Cynomolgus monkeys were used in preclinical studies. Dose range finding studies showed an increase in cynomolgus monkey kidney weight and decrease in body weight in respect to the control group, but both effects were reversible. The clearance of Sym004 is dependent on antibody mediated receptor internalization. Due to the efficiency of Sym004 induction of receptor internalization, repeat dose studies showed little accumulation of Sym004 and the clearance rate was higher than Cetuximab. Because EGFR is expressed in the skin and gastrointestinal tract, the only toxic side effects observed were rash and diarrhea, and presented much earlier than Cetuximab. Current Status: Phase I trials finished in June 2011 in patients with colorectal cancer and squamous cell carcinoma of the head and neck. Phase II trials were announced on 23 August 2011 and are continuing for 24 weeks, beginning at Antwerp University Hospital in Belgium. Patients are receiving weekly doses, and the drug is being evaluated on "safety, efficacy, and pharmacokinetics". References External links Official website Biotechnology companies of Denmark Life science companies based in Copenhagen Companies based in Ballerup Municipality Danish companies established in 2000