IGF::OT::IGF SBIR TOPIC 255 cGMP Manufacture of

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The objective of this NCI-SBIR manufacturing contract is to produce an immunotherapeutic to treat HER2/neu+ breast cancer. HER2/neu, a member of the epidermal growth factor receptor (EGFR) family, is a transmembrane tyrosine kinase receptor associated with the pathogenesis of certain breast adenocarcinomas. HER2/neu overexpression has been indentified in about one third of invasive breast cancers and is associated with more aggressive progression, shofter relapse time, poorer overall survival, increased cell proliferation, increased regional and distant metastases, accelerated angiogenesis, and reduced apoptosis of cancer cells. The immunogenicity of HER2/neu has been clinically demonstrated and it is a promising target for immunotherapeutic approaches. HER2/neu is classified as a priority target by the NCl. Etubics will emptoy its E.C7 human manufacturing cell line to produce the AdS [E1-, E2b-]-HER2 product that is designed to overcome pre-existing AdS immunity in patients that challenges other vector approaches. This platform contains the HER2/neu gene and induces robust immune responses against the gene target that inhibits tumor progression and may prevent metastases. Our goal is to complete the Aims of this contract and submit an IND to the FDA to initiate a phase l/lla clinical trial to treat HER2/neu+ breast cancer.