A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC)

Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of HPV16+ squamous cell carcinoma of the head and neck post standard of care definitive therapy. * History of histologically confirmed HPV16+ squamous cell cancer (from in-house or local evaluation by HPV16 RNA in situ hybridization (ISH) or PCR) is required for all patients on study. * Detection of HPV16 specific TTMV-HPV DNA via peripheral blood NavDx assay in combination with historically confirmed p16 expression can be used as a surrogate for enrollment and initiation of treatment as per the discretion of site PI whilst histological confirmation with RNA ISH or PCR is in process. * No clinical or radiographic evidence of persistent or recurrent disease at time of evaluation (indeterminate findings are allowed based on discretion of P.I.) * Positive TTMV-HPV DNA score (HPV16 specific) by NavDx® 3 months or more after definitive therapy for HPV16+ squamous cell carcinoma of the head and neck allows for pre-screen consent for a confirmatory NavDx. * Definitive therapy includes surgery and/or chemotherapy/radiation therapeutic paradigms that are aimed at eradicating and curing disease with the goal of no additional therapies being required afterwards. This will include standard of care treatments and IRB-approved, de-escalation treatment protocols and strategies.For those patients who had surgery only as definitive therapy, a positive TTMV-HPV DNA score after completion of surgery fu…