other material
confidence high
sentiment neutral
materiality 0.85
PDS Biotech refocuses on PDS0301 in mCRC; discontinues PDS0101 Phase 3 trial
PDS Biotechnology Corp
- PDS0301 showed 71% ORR at 6 months and 80% 24-month survival in MSS/pMMR mCRC with liver metastases.
- Company discontinues PDS0101 Phase 3 VERSATILE-003 trial and will pursue strategic partnerships for PDS0101.
- PDS0301 has been studied in >380 patients with encouraging safety; Phase 2b trial designed with FDA feedback.
- PDS0301 also evaluated in prostate, Kaposi sarcoma, HPV16+ cancers via NCI-sponsored trials.
- Q2 2026 financial results scheduled for announcement on August 13, 2026.