PDS Biotechnology Showcases Robust Clinical and Immunological Responses With PDS0101 and PDS01ADC in New SITC 2025 Data
Translational Findings Validate Broad and Predictive Immune Activation in Advanced Cancers
On November 10, 2025, PDS Biotechnology (NASDAQ: PDSB) presented pivotal data at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. The results highlight how their novel immunotherapies, PDS0101 and PDS01ADC, drive powerful immune responses in patients with advanced, difficult-to-treat cancers. The latest clinical and translational data provide new evidence that these therapies can both trigger and predict long-lasting anti-tumor activity.
Key Insights: Immune Biomarkers and Clinical Benefit Go Hand-in-Hand
At SITC 2025, a study involving 50 patients with HPV16-positive cancers treated with a combination of PDS0101, PDS01ADC, and an immune checkpoint inhibitor showed notable immune system activation. Specifically, patients experienced:
- Increased pro-inflammatory cytokines, crucial for recruiting and activating T cells against cancer.
- Quantifiable blood protein markers that accurately predicted which patients would benefit most.
These results underscore the promise of blood-based biomarker monitoring, helping doctors better tailor immunotherapy treatments for individual patients. Importantly, the rapid oral abstract reporting these findings was recognized among the top 150 presentations at SITC this year.
| Study Group | Patients | Therapy | Key Immune Changes | Predictive Biomarkers |
|---|---|---|---|---|
| HPV16-positive Cancers | 50 | PDS0101 + PDS01ADC + Checkpoint Inhibitor | Broad T cell and cytokine activation | Blood protein markers for clinical benefit |
PDS01ADC Shows Targeted Reprogramming of Immune Cells
Data on PDS01ADC, an investigational IL-12 immunocytokine, indicate that this therapy can actively reprogram a patient's natural killer (NK) and T cells:
- PDS01ADC increased multifunctional NK cells tied to better clinical responses in patients with advanced solid tumors.
- The therapy boosted specific NK cell populations that efficiently kill tumor cells, while reducing those associated with poorer responses.
- Further findings reveal PDS01ADC increases stem-like, self-replicating memory T cells (both CD8 and CD4) that are associated with prolonged anti-tumor immunity and disease stabilization in treatment-resistant cancer.
| Therapy | Cellular Changes | Clinical Outcome |
|---|---|---|
| PDS01ADC Monotherapy | ? Multifunctional NK cells ? Stem-like memory T cells |
Improved tumor control and disease stabilization |
Scientific Rationale Supports Next Steps in Clinical Development
These mechanistic insights, validated through partnerships with the National Cancer Institute, build confidence in PDS Biotechnology’s approach. The connection between immune biomarkers and positive patient outcomes could pave the way for more personalized and effective immunotherapy regimens.
Looking forward, PDS Biotech is progressing with a pivotal Phase 3 trial evaluating PDS0101 with pembrolizumab (Keytruda®) in HPV16-positive head and neck cancers. Simultaneously, PDS01ADC continues in multiple Phase 2 trials for other solid tumor types, backed by these translational results.
What This Means for Investors and Patients
The 2025 SITC presentations underscore PDS Biotechnology’s scientific momentum and its progress toward critical regulatory and clinical milestones. As the link between immune system signatures and patient response grows clearer, PDSB stands to potentially advance new, tailored cancer immunotherapies in areas of significant unmet need.
With a current stock price of $1.01 (as of 11:18 AM), investors may be watching closely to see how ongoing studies, biomarker strategies, and regulatory developments will shape PDSB’s future. These recent findings could provide an important foundation for further clinical advances—and, ultimately, improved outcomes for patients facing aggressive cancers.
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