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PDS0101 + PDS01ADC + immune checkpoint inhibitor
- Development stage
- Unknown
- Lead developer
- PDS Biotech
- Modality
- Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics, Vaccines & Immunotherapeutics
- Administration
- Subcutaneous, Intravenous
01
Overview
This triple combination immunotherapy regimen is being developed by PDS Biotechnology for the treatment of HPV16-positive recurrent or metastatic cancers. The regimen consists of **PDS0101**, a therapeutic vaccine targeting HPV16 E6 and E7 antigens using the Versamune platform; **PDS01ADC** (also known as M9241), an antibody-conjugated interleukin-12 (IL-12) immunocytokine designed to deliver IL-12 directly to the tumor microenvironment; and an **immune checkpoint inhibitor** (typically a PD-1 inhibitor such as pembrolizumab). The mechanism of action involves PDS0101 priming and expanding HPV-specific CD8+ and CD4+ T cells, while PDS01ADC enhances T-cell infiltration and activation within the tumor, and the checkpoint inhibitor prevents tumor-mediated immune suppression. This synergistic approach aims to overcome the low response rates seen with checkpoint inhibitor monotherapy in HPV-associated malignancies.
- Other names
- Triple Combination TherapyVersamune HPV + PDS01ADC + ICI
02
Targets
HPV16 E6 oncoproteinPDCD1 (Programmed cell death protein 1 receptor)HPV16 E7 (Human papillomavirus 16 E7 protein)IL-12R (Interleukin-12 receptor)TGFB (GARP–latent transforming growth factor beta 1 complex)CD274 (Programmed cell death protein 1 ligand 1)Nucleosome (DNA–histone complex)
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