Drugs / PEXIPEPIMUT-S
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05232851 | Jun 2022 → Apr 2025 overdue | human papillomavirus-related squamous cell carcinoma, oropharyngeal carcinoma | Mayo Clinic | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04287868 | Jun 2020 → Jul 2022 | anal carcinoma, cervical cancer, oropharyngeal carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07090174 | Oct 2025 → Jul 2026 overdue | HIV infectious disease, anal carcinoma, cervical cancer, human papilloma virus infection +1 | Weill Medical College of Cornell University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04260126 | Mar 2021 → May 2025 | oropharynx squamous cell carcinoma | PDS Biotechnology Corp. | Completed | No outcome recorded |
| Phase 2 | NCT04580771 | Oct 2020 → Mar 2027 expected | cervical cancer | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06790966 | May 2025 → Aug 2026 | oropharynx squamous cell carcinoma | PDS Biotechnology Corp. | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-09-22 | PDS Biotechnology Corp. | Results PDS Biotech Announces Publication of VERSATILE-002 Phase 2 Clinical Trial Results of PDS0101 with pembrolizumab in HPV16-Positive Recurrent and/or Metastatic (R/M) Head and Neck Cancer in JAMA Oncology pdsbiotech.com ↗ |
| 2026-01-09 | PDS Biotechnology Corp. | Regulatory PDS Biotech Announces FDA Alignment on use of Progression Free Survival (PFS) as Primary Endpoint pdsbiotech.com ↗ |
| 2025-11-13 | PDS Biotechnology Corp. | Results PDS Biotech Reports Third Quarter 2025 Financial Results and Provides Clinical Programs Update pdsbiotech.com ↗
Announced final topline survival data from the VERSATILE-002 Phase 2 clinical trial. |
| 2025-11-10 | PDS Biotechnology Corp. | Results PDS Biotechnology Announces Translational Data Showing Strong Immunological and Clinical Activity of PDS0101 and PDS01ADC Presented at SITC 2025 pdsbiotech.com ↗
The presentations highlight immune-driven mechanisms and biomarkers that explain strong clinical activity of the Company’s investigational HPV16-targeted immunotherapy PDS0101 and its novel, investigational immunocytokine PDS01ADC. |
| 2025-09-18 | PDS Biotechnology Corp. | Results PDS Biotech Sets Significant Benchmark in Head and Neck Cancer by Achieving Extended Survival in Low PD-L1 Expression (CPS 1–19) Cohort in VERSATILE-002 Trial, Potentially Eliminating Need for Chemotherapy in the Population pdsbiotech.com ↗
First combination therapy to report 29.5 months of Median Overall Survival (mOS); Standard of care Keytruda ® (pembrolizumab) alone (10.8 months) and Keytruda ® + chemotherapy (12.3 months) in patients with CPS 1-19* |
| 2025-08-25 | PDS Biotechnology Corp. | Results PDS Biotech Announces Final Topline Survival Data from VERSATILE-002 Phase 2 Trial in Head and Neck Cancer pdsbiotech.com ↗
The median overall survival (mOS) is 39.3 months in patients with CPS ≥ 1. |
| 2021-05-18 | EMD Serono Research & Development Institute, Inc. | Results Data from EMD Serono’s Oncology Portfolio Highlight Significant Advances in Cancer Care at ASCO21 emdserono.com ↗
Data from this NCI-led Phase II clinical study of patients with advanced HPV 16+ cancers provided early evidence of the clinical activity of a triple combination of bintrafusp alfa, NHS-IL12 and PDS0101, with a manageable safety profile. |
All press releases naming this drug 13 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PEXIPEPIMUT-S | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095479 ↗ |
| Known as | PDS0101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04287868 ↗ |
| Action | Activate | “by activating multiple immune pathways” NCT04260126 ↗ |
| Modality | Vaccine | “the HPV type 16 therapeutic vaccine PDS0101” PMID 39976981 ↗ Apr 2025 |
| Route | Subcutaneous | “two 0.5mL sub-cutaneous injections of PDS0101 administered on Cycle 1, 2, 3, 4 and 12” NCT04260126 ↗ |