Jun. 14 at 4:09 AM
$PDSB
🔹 Target Population:
PDS Biotech focuses on patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who are HPV16-positive.
Most of these patients are in advanced stages of the disease, not eligible for surgery, and have not previously received PD-1 inhibitors (such as Keytruda).
🔹 Current Status:
• The company’s lead clinical trial, VERSATILE-003, requires participants to be PD-1–naïve (i.e., not previously treated with anti–PD-1 therapy).
• Merck’s KEYNOTE‑689 trial, by contrast, targets early-stage, resectable HNSCC patients, most of whom are not HPV16-positive (only 3.3%–4.3% were HPV+).
• As a result, there is little to no overlap between the patients treated under the new Keytruda perioperative label and PDSB’s target population.
🔹 Conclusion:
✅ There is no immediate impact on PDS Biotech, as its current target population is not affected by the new Keytruda indication.
