4.3.5 Vaccine a. Dosage and Preparation The E75 vaccine (HER2/neu p369-377) will be supplied by Galena Biopharma. The E75 acetate drug substance is a 9-amino acid peptide produced by solid-phase peptide synthesis. E75 acetate drug product is manufactured by Oso Biopharmaceuticals Manufacturing, Albuquerque, NM as a 1.5 mg/mL solution in 1 mL water for injection (WFI) in a 2-mL glass vial. The control is Water For Injection (WFI). Prior to administration, 0.8 mL of the E75 acetate or control is mixed by the pharmacist or research nurse with 1 mL of reconstituted lyophilized Leukine® (250 µg GM-CSF/mL in solution). Immediately after mixing, the study drug is withdrawn into four 1 mL syringes and within 6 hours, a total of 1.6 mL is administered as 4 intradermal injections. The control vial contains 1 mL WFI. The guidance for mixing E75 (or control) solution from lyophilized Leukine® 250 µg and test drug (E75 solution or control) is stated in Appendix G. Galena Biopharma, Inc. will supply both agents, the E75 and the GM-CSF. Leukine® (sargramostim) is a recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast (S. cerevisiae) expression system.