8-KAccepted Sep 22, 8:05 AM ET
PDS Biotechnology Corp Announces Publication of Phase 2 Trial Results
Accepted (ET)
8:05 AM
Sep 22, 2026
Filed
Sep 22, 2026
Documents
13
Size
173.1 KB
Summary
PDS Biotechnology Corp Announces Publication of Phase 2 Trial Results
What Happened
PDS Biotechnology Corporation (PDSB) filed a Form 8-K on September 22, 2026, announcing a press release that the results from its Phase 2 trial of PDS0101 (an HPV16-targeted T‑cell immunotherapy) combined with pembrolizumab were published in the September 17, 2026 issue of JAMA Oncology. The article is titled “VERSATILE-002 – A Phase 2 Study of PDS0101 HPV16-targeted T Cell Immunotherapy and Pembrolizumab Combination in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Nonrandomized Clinical Trial.”
Key Details
- Form 8-K filed September 22, 2026 (Item 8.01: Other Events).
- Results published in JAMA Oncology on September 17, 2026.
- Trial name: VERSATILE-002; indication: HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
- Combination studied: PDS0101 (HPV16-targeted immunotherapy) plus pembrolizumab; company press release included as Exhibit 99.1.
Why It Matters
Publication in a peer-reviewed journal like JAMA Oncology gives the VERSATILE-002 Phase 2 data formal scientific validation and broader visibility to clinicians, researchers, and potential partners or investors. The filing reports the publication event itself (not new financial results or regulatory approvals), so investors should view this as an update on clinical development and scientific communication rather than a direct financial disclosure.