PDS Biotechnology Q4 2022 Earnings Report
Key Takeaways
PDS Biotechnology announced the completion of key activities to initiate a global, multicenter Phase 3 registrational trial investigating the combination of PDS0101 and KEYTRUDA® in Q4 2023. The trial, named VERSATILE-003, will investigate the combination compared to KEYTRUDA® monotherapy for the treatment of unresectable, recurrent/metastatic human papillomavirus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC).
Completed key tech transfer, scale up and manufacturing activities required to initiate a Phase 3 trial.
Phase 3 trial, VERSATILE-003, will investigate PDS0101 and KEYTRUDA® combination compared to KEYTRUDA® monotherapy.
PDS Biotech plans to submit an amended Investigational New Drug (IND) application to the FDA in Q3 2023.
FDA granted Fast Track designation to the combination of PDS0101 and KEYTRUDA for the treatment of HPV16-positive HNSCC.