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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Head and Neck Cancer |
| Drug: | Keytruda (pembrolizumab) (PD1 inhibitor) + PDS0101 (Immunostimulant, HPV-16 E6 protein inhibitor, HPV-16 E7 protein inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
PDS Biotechnology Granted FDA Fast Track Designation for Lead Candidate PDS0101
Published date:
06/02/2022
Excerpt:
PDS Biotechnology Corporation (Nasdaq: PDSB)...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). PDS0101 in combination with KEYTRUDA® is being studied in the VERSATILE-002 Phase 2, open-label, multicenter trial for the treatment of recurrent or metastatic HPV16-positive head and neck cancer in collaboration with Merck (known as MSD outside the US and Canada).
