PDSB - PDS Biotechnology Corp (PDSB) - Clinical Milestone Reached - Raising Price Target
Raising Our Price Target PDS Biotech announced that it has completed enrollment of the safety cohort in the Phase 2 VERSATILE-002 study. This is one of the clinical milestones we had expected in 2H21. We believe this shows development progress as well as proof-of-concept for the Versamune technology platform. We are raising our price target to $22 per share, up from $17.VERSATILE-002 Study Design: The Phase 2 VERSATILE-002 study is testing PDS0101 with the checkpoint inhibitor Keytruda (pembrolizumab, from Merck, MRK, $73.45, Not Rated). It is an open-label, single-arm trial testing the combination of PDS0101 with Keytruda against Keytruda alone in patients with advanced human papilloma virus-16-associated (HPV-16) head and neck cancer that has recurred or spread. Target enrollment is about 100 patients at 25 clinical sites in the US.PDS0101 Reached Another Clinical Milestone Enrollment has been completed for the lead-in safety cohort for evaluation by a Drug Safety and Monitoring Board (DSMB). The trial is designed with a first group of checkpoint inhibitor naïve (not previously treated), and a second group that has failed multiple treatments including checkpoint inhibitor therapy (CPI refractory). The trial will resume enrollment following the DSMB evaluation. Three Clinical Trials Are Ongoing With PDS0101: PDS0101 was developed to stimulate a strong immune response against the HPV16 antigen. A separate Phase 2 trial is testing PDS-001 in combination with two other immune modulating drugs (bintrafusp and Il-12) recently presented initial data in ASCO 2021. A third trial tests PDS0101 in combination with chemotherapy and radiation for advanced cervical cancer. Conclusion: PDS Biotechnology continues to meet its clinical milestones, with additional data expected in late 2021 through 2022. Clinical trials for two additional Versamune products, PDS102 and PDS103, are planned for 1H22. Based our our estimated time to market and evidence supporting the Versamune technology platform, we are increasing our price target to $22 per share. Read More >>