OncoTab proposes to develop a targeted radionuclide therapy using its patented tumor-specific antibody designated TAB004 for Triple Negative Breast Cancers. The tumor specific nature of tihs newly discovered antibody makes this an ideal molecule for targeted radiotherapy applications both for TNBC patients and eventually in patients with other types of malignancies that express this MUC1 variant. We propose to fully humanize this antibody and use innovative techniques developed by investigators at Duke (Drs. Vaidyanathan and Zalutsky) to (1) test the feasibility of labeling TAB004 with radioiodine, 131I; (b) evaluate the binding affinity and internalization of I-131 labeled TAB004 in retarding growth and reducing the size of TNBC tumors in mice. Finally we propose to initiate preliminart toxivity studies. The overarching goal of this Phase I proposal is to determine if TAB004 can be used for targeted radioimmunotherapy of TNBC. Successful completion will lead to Phase II activities focused on scaling up manufacturing and IND enabling studies in consultation with the FDA for a fast track approval.OncoTab proposes to develop a targeted radionuclide therapy using its patented tumor-specific antibody designated TAB004 for Triple Negative Breast Cancers. The tumor specific nature of tihs newly discovered antibody makes this an ideal molecule for targeted radiotherapy applications both for TNBC patients and eventually in patients with other types of malignancies that express this MUC1 variant. We propose to fully humanize this antibody and use innovative techniques developed by investigators at Duke (Drs. Vaidyanathan and Zalutsky) to (1) test the feasibility of labeling TAB004 with radioiodine, 131I; (b) evaluate the binding affinity and internalization of I-131 labeled TAB004 in retarding growth and reducing the size of TNBC tumors in mice. Finally we propose to initiate preliminart toxivity studies. The overarching goal of this Phase I proposal is to determine if TAB004 can be used for targeted radioimmunotherapy of TNBC. Successful completion will lead to Phase II activities focused on scaling up manufacturing and IND enabling studies in consultation with the FDA for a fast track approval.
