Drug intelligence / Profile preview

PDS0101 + chemoradiation therapy

Development stage
Unknown
Lead developer
PDS Biotech
Modality
Implantable Devices → Device-based Delivery → Drug Delivery Systems, Small Molecules, Vaccines & Immunotherapeutics
Administration
Subcutaneous, Intravenous
01

Overview

PDS0101 in combination with chemoradiation therapy is an investigational treatment regimen being developed for locally advanced cervical cancer. PDS0101 is a subcutaneous HPV-specific T cell immunotherapy based on the proprietary Versamune platform, designed to target and induce a potent T cell response against HPV16 E6 and E7 oncoproteins. In this combination approach, PDS0101 is administered alongside standard-of-care chemoradiotherapy (CRT) to enhance the immune system's ability to clear HPV-positive tumor cells. The regimen is currently being evaluated in the Phase 2 IMMUNOCERV trial, specifically for patients with high-risk, locally advanced squamous cell cervical cancer with lymph node metastasis or large tumors. Preliminary data has shown high overall response rates and significant tumor shrinkage with a manageable safety profile.

Brand names
Versamune HPV
Other names
PDS0101 + CRTPDS0101 + chemoradiotherapy
02

Targets

HPV16 E6 oncoprotein

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