1 Abbreviated Title: Combo Immunotx in HPV OPSCC Version Date: 04.25.2023 Abbreviated Title: Combo Immunotx in HPV OPSCC NIH Protocol #: 20C0104 Version Date: April 25, 2023 NCT Number: NCT04432597 IBC Registration: RD-20-V-22 RSC Number: 2763 Title: Phase I/II Trial of HPV Vaccine PRGN-2009 Alone or in Combination with Anti-PD- L1/TGF-β trap (M7824) in Subjects with HPV Associated Cancers NCI Principal Investigator: Charalampos Floudas, MD, DMSc, MS Center for Immuno-Oncology (CIO) Center for Cancer Research (CCR) National Cancer Institute (NCI) Building 10, Room 7N240A Bethesda, MD 20892 Phone: 240-858- 3032 Email: charalampos.floudas@nih.gov Drug Name: PRGN-2009 M7824 IND Number: 19628 19628 Sponsor: CCR, NCI CCR, NCI Manufacturer: Precigen, Inc. EMD Serono, Inc.