PDS0101

P2, N=22, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=35 --> 22 | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025

"Forty-seven patients with cervical cancer were enrolled on this study between 2017 and 2022, either as part of a standard-of-care (SOC) treatment banking protocol (33 patients) or as part of a clinical trial combining a therapeutic HPV vaccine (PDS0101; Immunocerv, 14 patients)...Treatment with a therapeutic HPV vaccine was associated with a more rapid decline in cfHPV DNA. Further analysis of cfDNA kinetics could provide valuable information on the relationship between cfDNA levels, treatment response, and clinical outcomes."

Conclusions The PDS0101/pembrolizumab combination generates polyfunctional CD4 and CD8 T cells that secrete multiple cytokines and chemokines associated with a predominant effector, stimulatory functional profile. Further investigation of T cell polyfunctionality and correlation with clinical outcomes is warranted.

P1/2, N=51, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2024 --> Jul 2026 | Trial primary completion date: Jun 2023 --> Jul 2022

P2; Recruiting --> Active, not recruiting | Trial primary completion date: May 2023 --> Jun 2024

Background The novel, investigational HPV-targeted immunotherapy PDS0101 is being studied in combination with pembrolizumab in a phase 2 clinical trial (NCT04260126) in patients with HPV16-positive head and neck cancer. Conclusions PDS0101 treatment induces polyfunctional CD4 and CD8 T-cell responses across multiple timepoints. Additional studies of cell-specific functional profiles in larger numbers of subjects and correlation with clinical outcomes are planned.

P1/2, N=51, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Jan 2024

P1/2, N=56, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2023 --> Jun 2023 | Trial primary completion date: Jun 2022 --> Jun 2023

The combination of PDS0101 and pembrolizumab demonstrates an excellent safety profile with preliminary evidence of clinical activity in the majority of CPI naïve patients with HPV-related HNSCC.

P1/2, N=56, Recruiting, National Cancer Institute (NCI) | Trial primary completion date: Jan 2022 --> Jun 2022

P1/2, N=56, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting | N=21 --> 56

P1/2, N=21, Suspended, National Cancer Institute (NCI) | N=56 --> 21 | Recruiting --> Suspended

Case Description A 62 year-old male with squamous cell carcinoma of the head and neck refractory to chemotherapy, radiation and proton therapy was admitted for dysphagia, fever and hypotension two weeks after starting experimental immunotherapy with bintrafusp, NHS/IL-12, and PDS101. Awareness of these adverse events is necessary as these medications see more widespread use. The views expressed are those of the authors and do not necessarily reflect the official policy the Department of Defense or the U.S. government.

P1/2, N=45, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2022 --> Jan 2023 | Trial primary completion date: Jul 2021 --> Jan 2022

P2, N=96, Recruiting, PDS Biotechnology Corp. | Initiation date: Nov 2020 --> Feb 2021

P2, N=96, Recruiting, PDS Biotechnology Corp. | Not yet recruiting --> Recruiting

These studies provide the rationale for the potential clinical use of combinations of agents that can (1) induce tumor-associated T-cell responses, (2) potentiate immune responses in the TME and (3) reduce immunosuppressive entities in the TME.

P2, N=96, Not yet recruiting, PDS Biotechnology Corp.