PDS Biotechnology Corporation

09/22/2026 | Press release | Distributed by Public on 09/22/2026 06:05

Company continues to prioritize PDS0301 in metastatic colorectal cancer (mCRC) while pursuing partnership strategy for PDS0101 (Form 8-K)

Company continues to prioritize PDS0301 in metastatic colorectal cancer (mCRC) while pursuing partnership strategy for PDS0101
PRINCETON, N.J., September 22, 2026 -- PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced the publication of results from a Phase 2 trial evaluating PDS0101, its HPV16-targeted immunotherapy, in combination with pembrolizumab in the September 17, 2026, issue of JAMA Oncology, a peer reviewed journal of the American Medical Association. The data were published in an article 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 findings
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62.3% of the ICI-naïve participants in the mITT cohort (n = 53) had low CPS of 1-19, and 37.7% had high CPS ≥ 20. In the overall CPS ≥ 1 population, the mOS was 39.3 months (95% CI, 23.9 to NE); The best published result with standard of care pembrolizumab or pembrolizumab + chemotherapy is 17.9 months 1.
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Objective response rate (ORR) for CPS ≥ 1 was 36% of which 5/53 were complete responders by investigator review and 34% of which 6/53 were complete responders by central review.
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The published ORR for the overall population with CPS ≥ 1 when treated with standard of care pembrolizumab is 19%2.
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The treatment was well-tolerated with 13.8% Grade ≥3 treatment-related adverse events (TRAEs), 1 Grade 4 event one year after PDS0101 therapy, and no Grade 5 TRAEs.
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The published safety profile for the overall population with CPS ≥ 1 when treated with standard of care pembrolizumab reports 17% Grade ≥ 3 TRAEs 2.
VERSATILE-002 was an open-label, non-randomized phase 2 trial performed at twenty-six oncology centers across the US, UK and Ireland. Eighty-eight patients with histologically confirmed R/M HPV16-positive diseases were enrolled in the study; 87 received treatment and comprised the safety population; 75 were in the modified Intention-to-Treat (mITT) population used for efficacy analyses: 53 ICI-naïve with PD-L1 CPS ≥1, 22 ICI-resistant (Mean age = 64.5 years, 94.7% male, 92.0% White).
The trial was led by Dr. Jared Weiss, MD, of the Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, and was performed to determine the efficacy and safety of PDS0101, in combination with pembrolizumab in participants with HPV16-positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC), with separate evaluation of immune checkpoint inhibitor (ICI)-naïve and -resistant cohorts.
"We're very pleased with the publication of the Phase 2 clinical results of the VERSATILE-002 clinical trial in a leading peer reviewed oncology journal," said Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech. "These results support the durable clinical effect of PDS0101, consistent with promising survival outcomes reported in two other recently published studies, the IMMUNOCERV study, and the NCI-led study in HPV16-positive recurrent and/or metastatic cancers. We believe PDS0101 has the potential to bring new hope to the rapidly growing population of HPV16-positive head and neck cancer patients."
The Company recently announced the initial closing of a PIPE financing of up to $22.3 million led by Nant Capital, alongside an agreement granting NantWorks, LLC, an affiliate of Nant Capital, a one-year exclusive right to negotiate an exclusive license to PDS0101.
*No head-to-head trials have been performed.
1Licitra L et al, J Clin Oncol; 2026 Apr 20;44(12):1098-1107.doi: 10.1200/JCO-25-00570. Epub 2026 Mar 12
2Harrington, KJ et al. J Clin Oncol. 2022;41:790-802. https://doi.org/10.1200/JCO.21.02508.
About PDS Biotechnology
PDS Biotechnology is a clinical-stage biotechnology company focused on developing targeted immunotherapies for cancer. PDS Biotechnology owns the Versamune® cancer vaccine platform, including PDS0101, which has been evaluated in HPV16-positive cancers. The Company intends to pursue strategic partnerships or other externally funded opportunities for the Phase 3 development of PDS0101.
The Company's lead development program, PDS0301 (also referred to as PDS01ADC & NHS-IL12), is an investigational tumor-targeted interleukin-12 (IL-12) immunocytokine designed to deliver IL-12 preferentially to the tumor microenvironment, with the goal of enhancing anti-tumor immune activity while limiting systemic exposure. PDS0301 has been clinically evaluated across multiple solid tumors, including metastatic colorectal cancer and prostate cancer. The Company is focused on advancing PDS0301 in indications where its tumor-targeted mechanism may help address and overcome mechanisms of resistance to immunotherapy.
For more information, please visit www.pdsbiotech.com
PDS Biotechnology Corporation published this content on September 22, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on September 22, 2026 at 12:07 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]