8-K: PDS Biotech's VERSATILE-002 Trial Shows Promising Results in Head and Neck Cancer, Phase 3 Trial Planned

PDS Biotechnology's VERSATILE-002 Phase 2 trial demonstrated a 30-month median overall survival in first-line recurrent/metastatic HPV16-positive head and neck cancer, significantly exceeding historical benchmarks.

Summary

• PDS Biotechnology hosted a Key Opinion Leader event on May 8, 2024, to discuss positive data from the VERSATILE-002 trial.
• The VERSATILE-002 trial is evaluating the combination of Versamune HPV and KEYTRUDA (pembrolizumab) in patients with HPV16-positive head and neck squamous cell cancer (HNSCC).
• The trial achieved a median overall survival (mOS) of 30 months in first-line recurrent metastatic HNSCC patients, compared to published results of 7-18 months for immune checkpoint inhibitors.
• The best overall response (BOR) by investigator assessment was 34% for patients with a Combined Positive Score (CPS) of 1 and 48% for patients with a CPS of 20.
• Published results for immune checkpoint inhibitors show BOR of less than 20% for CPS>1 and less than 25% for CPS20.
• Progression-free survival (PFS) was 6.3 months for CPS1 and 14.1 months for CPS20, compared to published results of 2-3 months for immune checkpoint inhibitors.
• The combination of Versamune HPV and pembrolizumab was well tolerated.
• The company plans to initiate a Phase 3 registrational trial in 2024 focusing on a triple combination of Versamune HPV, PDS01ADC, and pembrolizumab as a first-line treatment.
• PDS01ADC is a novel, investigational tumor-targeting IL-12-fused antibody-drug conjugate (ADC).

Sentiment

Score: 9

Explanation: The document presents very positive clinical trial results with significant improvements over existing treatments, indicating a strong potential for the company's technology. The planned Phase 3 trial further reinforces the positive outlook.

Positives

• The 30-month median overall survival significantly exceeds the 7-18 month range seen with immune checkpoint inhibitors.
• The best overall response rates of 34% (CPS1) and 48% (CPS20) are substantially higher than the <20% and <25% seen with immune checkpoint inhibitors.
• The progression-free survival of 6.3 months (CPS1) and 14.1 months (CPS20) is much improved compared to the 2-3 months seen with immune checkpoint inhibitors.
• The trial data indicates a durable response in first-line recurrent and/or metastatic HNSCC patients with CPS1.
• The combination therapy was well tolerated.

Risks

• The company's ability to protect its intellectual property rights is a risk.
• The company's anticipated capital requirements and dependence on additional financing to fund operations and complete development are risks.
• The company has a limited operating history in its current line of business, making it difficult to evaluate prospects.
• The timing and success of planned clinical trials for PDS01ADC, PDS0101, PDS0203 and other product candidates are uncertain.
• The company's ability to continue as a going concern is a risk.

Future Outlook

The company plans to initiate a Phase 3 registrational trial in 2024 focusing on a triple combination of Versamune HPV, PDS01ADC, and pembrolizumab as a first-line treatment in HPV16-positive recurrent/metastatic HNSCC. The trial will have two parts, with the first focusing on dose optimization and the second being a randomized trial with overall survival as the primary endpoint.

Management Comments

• PDS Biotech believes that proof-of-concept long-term data have shown positive survival results and tumor shrinkage with this combination and indicate favorable tolerability.
• PDS Biotech believes that with a novel investigational inside-outside mechanism, the PDS01ADC and Versamune HPV immunotherapy has shown compelling results with potential to successfully disrupt a tumor's inside defenses, while also generating potent, targeted killer T-cells to attack the tumor from the outside.
• PDS Biotech believes that data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated the potential for both platforms and point to potential broad utility.

Industry Context

The announcement highlights the potential of PDS Biotechnology's immunotherapy approach in the competitive landscape of head and neck cancer treatment. The results significantly outperform historical benchmarks for immune checkpoint inhibitors, suggesting a potential shift in treatment paradigms for HPV16-positive HNSCC.

Comparison to Industry Standards

• The median overall survival of 30 months in the VERSATILE-002 trial is significantly higher than the 7-18 months typically seen with immune checkpoint inhibitors in similar patient populations.
• The best overall response rates of 34% (CPS1) and 48% (CPS20) are substantially better than the <20% (CPS>1) and <25% (CPS20) reported for immune checkpoint inhibitors.
• The progression-free survival of 6.3 months (CPS1) and 14.1 months (CPS20) also exceeds the 2-3 months typically observed with immune checkpoint inhibitors.
• These results suggest that PDS Biotechnology's combination therapy may offer a more effective treatment option compared to standard immune checkpoint inhibitor therapies, such as Keytruda alone, in this patient population.
• Competitors in the HNSCC space include companies developing other immunotherapies and targeted therapies, but the specific data from this trial positions PDS Biotech as a potential leader in the HPV16-positive HNSCC treatment landscape.

Stakeholder Impact

• Shareholders are likely to react positively to the strong clinical trial results and the planned Phase 3 trial.
• Patients with HPV16-positive HNSCC may benefit from a potentially more effective treatment option.
• Employees may be motivated by the positive progress of the company's lead program.
• The company's suppliers and partners may see increased business opportunities.

Next Steps

• Initiate a Phase 3 registrational trial in 2024 focusing on the triple combination of Versamune HPV, PDS01ADC, and pembrolizumab.
• Conduct dose optimization in the first part of the Phase 3 trial.
• Conduct a randomized second part of the Phase 3 trial with an interim data readout and overall survival as the primary endpoint.

Key Dates

Keywords

HNSCC, HPV16, Versamune HPV, KEYTRUDA, pembrolizumab, PDS01ADC, immunotherapy, clinical trial, overall survival, response rate, cancer treatment