As a continuation of our Phase I SBIR contract with the NCI, this Phase II application is directed towards the further development of a biosimilar Erbitux antibody, designated ch225, for the immunotherapy of EGFR+, KRAS mutation negative colorectal and head and neck cancers. In 2011, there were 141,210 new cases of colon and rectal cancers and 49,380 deaths in the United States accounting for the 12.2 billion dollars spent on colorectal cancer treatment of patients. In addition to colorectal cancer which is the third most common cancer and the third leading cause of cancer-related mortality in both men and women in the United States, head and cancer accounts for 45,000 additional cases that are eligible for Erbitux treatment. Based upon these statistics, Erbitux is an important treatment modality in oncology and if current clinical trials to demonstrate its effectiveness in non-small cell lung cancer are successful, its commercial value will greatly increase in the near future. In Phase I of this contract, ch225 with similar characteristics to Erbitux was developed in the laboratory using genetic engineering methods. Extensive characterization studies demonstrated its close identity to commercial Erbitux using mass spectroscopy, BiaCore analysis, glycosylation profiling, and binding characteristics on EGFR positive and negative cell lines. Based upon these results, this Phase II contract application will further the development of ch225 to the clinic by focusing on functional studies in cells including the identification of signal transduction pathways, its mode of action on tumor cells, and the its action in vivo including PK/PD analyses, and efficacy againt EGFR+ tumor models.
