pharmacist) will maintain an ongoing inventory of the investigational product supply according to standard site procedures. The investigational product 74 Abbreviated Title: Neoadjuvant IO for HNSCC Version Date: August 31, 2022 will be dispensed at the direction of an investigator for administration to a study participant enrolled on the clinical trial. Disposal of expired or unused product will be returned to the manufacturer or disposed of according to standard site procedures based on agreement between the manufacturer and the site. 14.1.2 Dosage Form: Suspension for injection Product Name ETBX-011 (Ad5 [E1-, E2b-]-CEA(6D) Vaccine) Dose 5 x 1011 VP (standard dose) Route of Administration SC injection Physical Description ETBX vaccine is supplied as a sterile, clear solution in a 2-mL single-dose vial. The vaccine is provided at a concentration of 5 x 1011 VP per 1 mL and contains ARM formulation buffer (20 mM TRIS, 25 mM NaCl, 2.5% glycerol, pH 8.0). Each vial contains approximately 1.3 mL of the vaccine. ETBX-011 should be stored at ≤ -60°C until ready for use. Manufacturer Etubics (a wholly owned subsidiary of ImmunityBio Inc., formerly known as NantCell, Inc; hereafter referred to as Immunity Bio ) Product Name(s): ETBX-061 (Ad5 [E1-, E2b-]-MUC1 Vaccine) Dosage Form: Suspension for injection Dose 5 x 1011 VP (standard dose) Route of Administration SC injection Physical Description ETBX vaccine is supplied as a sterile, clear solution in a 2-mL single-dose vial. The vaccine is provided at a concentration of 5 x 1011 VP per 1 mL and contains ARM formulation buffer (20 mM TRIS, 25 mM NaCl, 2.5% glycerol, pH 8.0).