No clinic ally relevant abnormal hematology, blood chemistry, urinalysis, or physical findings were observed. 14.1.3 Formulation and P reparation PDS0101 is a 2-vial formulation which is mixed 1:1 v/v just prior to administration. Vial #1 (ImmunoMAPK -RDOTAP) : is a sterile, turbid pharmaceutical suspension of liposomal nanoparticles composed of the pure R -enantiomer of the cationic (positively charged) lipid DOTAP (dioleoyl -trimethylammonium propane). The particle size is between 100 -200nm. RDOTAP is a novel i mmune modulator which induces the production of important cytokines and chemokines and also enhances the cytolytic T -Lymphocyte response when combined with the antigenic peptides. ImmunoMAPK -RDOTAP is has been evaluated at 3 dos e levels, 1.0, 3.0 and 10.0mg. Vial #2 (HPVmix) : is a s terile, clear and slightly viscous suspension consisting of 6 nononcogenic lipidated peptides selected from immunogenic regions of the human papillomavirus strain 16 E6 and E7 proteins. The peptides exist in a mixed micellar particulate state. The HPVmix formulation contains 20% by volume of dimethyl sulfoxide (DMSO). HPVmix is being evaluated at a single dose level of 2.7 mg. The 1:1 mixture of R -DOTA P and HPVmix (antigens) yields a mixture of liposomes and peptide mixed micelles in 10% DMSO. The nanoparticulate vaccine induces antigen specific T -cell therapeutic responses. 14.1.4 Stability and Storage ImmunoMAPK -RDOTAP (Vial #1) and HPV Mix (Vial #2) Storage: Store at -70 oC ± 10oC. 85 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 Shipping: Shipped on dry ice in insulated container. Always check the temperature monitoring device to ensure maintenance of required storage condition during shipment. R-DOTAP Thawing: Place at room temperature for a minimum of 90 minutes (1.5 hours) prior to mixing with HPVmix. HPVmix Thawing: Remove from freezer at least 60 minutes (1 hour) after removal of RDOTAP. Place at room temperature for a minimum of 30 minutes (0.5 hours) and a maximum of 90 minutes (1.5 hours) prior to mixing with RDOTAP. Mixture: PDS0101 should not be administered if held in vial for more than 120 minutes (2 hours) at ambient temperature after mixing. 14.1.5 Administration P rocedures Subcutaneous administration in a limb. Each subsequent vaccination should preferably be administered alternating between limbs (e.g., L arm  R arm). Two separate 0.5 mL injections preferably ~ 6 cm apart of v accine in the same extremity Total Dose: 3.0mg R- DOTAP/2. 7 mg HPV Peptides 14.1.6 Incompatibilities Not available. 14.2 M7824 (MSB0011359C) (IND # 019267) 14.2.1 Source / Acquisition and Accountability M7824 is manufactured and supplied for the trial by EMD Serono Research and Development Institute . M7824 will be provided to the clinical trial site by the manufacturer. The investigator or designee (e.g., pharmacist) will maintain an ongoing inventory of the investigational product supply according to standard site procedures. The investigational product will be dispensed at the direction of an i nvestigator 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. 14.2.2 Toxicity The immunoglobulin portion of M7824 molecule is identical to avelumab (Bavencio). Respective warni ngs and precautions for grade 2 or higher immune -mediated pneumonitis, immune -mediated colitis, immune -mediated endocrinopathies, immune -mediated hepatitis) and infusion reactions are included in the prescribing for Bavencio (bavencio.com). P articipants will be pre -medicated to prophylax against infusions reactions. The following additionally significant immune -mediated adverse reactions have occurred in less than 1% of 1738 participants treated with BAVENCIO: myocarditis with fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain- Barré syndrome, and systemic 86 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 inflammatory response. The above irAEs are all considered an anticipated risk of treatment with M7824 and thus will not be considered DLTs. In a phase 1, open- labe l 3+3 dose -escalation study of M7824 in 16 participants , 3 participants experienced grade 3 drug -related adverse events including skin infection secondary to grade 2 bullous pemphigoid, lipase increased, and colitis with associated anemia. There were no grade 4 – 5 treatment related adverse events.