PDS Biotechnology Corp PDSB
PDS Biotechnology Corp (Nasdaq: PDSB) is an oncology drug developer. Its lead program, PDS0301 (formerly PDS01ADC / NHS-IL12), is in Phase 2 for metastatic colorectal cancer with liver metastases (also prostate cancer, Kaposi sarcoma, other liver-associated cancers). Its next catalyst on record is PDS0301: PDS0301 interim data readout in biochemically recurrent prostate cancer expected Q4-2026/Q1-2027. (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: PDS0301 — PDS0301 interim data readout in biochemically recurrent prostate cancer expected Q4-2026/Q1-2027. (Q4 2026). 9 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| PDS0101 (Versamune HPV16 vaccine) VERSATILE-003 vs pembrolizumab | HPV16-positive recurrent/metastatic head and neck cancer | vaccine | Phase 3 |
| PDS0301 + chemotherapy (NCI-led Phase 2) | MSS/pMMR metastatic colorectal cancer with liver metastases | antibody | Phase 2 |
| PDS0301 + enzalutamide | biochemically recurrent prostate cancer | antibody | Phase 2 |
| PDS0301 + docetaxel | metastatic castration-resistant prostate cancer | antibody | Phase 2 |
| PDS0301 monotherapy | advanced Kaposi sarcoma | antibody | Phase 2 |
| PDS0101 + pembrolizumab (VERSATILE-002) | HPV16-positive recurrent/metastatic head and neck cancer | vaccine | Phase 2 |
| PDS0101 + chemoradiotherapy (IMMUNOCERV) | locally advanced cervical cancer | vaccine | Phase 2 |
| PDS0101 +/- pembrolizumab | locally advanced HPV16-positive head and neck cancer | vaccine | Phase 2 |
| PDS0101 + PDS0301 + ICI | HPV16-positive recurrent/metastatic cancers | vaccine | Phase 2 |
| PDS0301 Phase 3 (planned registrational) | metastatic colorectal cancer with liver metastases | antibody | Pre-clinical |
Recent results and decisions
- Oct 21, 2026positive PDS0301 combined with chemotherapy achieved 71.4% objective response rate at six months in MSS/pMMR metastatic colorectal cancer with liver metastases.
In an NCI-led Phase 2 trial in MSS/pMMR* metastatic colorectal cancer (mCRC) with liver metastases, chemotherapy plus PDS0301 achieved a 71.4% response rate at six months and approximately 80% 24-month survival.
Filing - May 13, 2026completed enrollment Enrollment completed in the PDS01ADC metastatic colorectal cancer Phase 2 trial; VERSATILE-003 enrollment has not yet restarted under the amended protocol.
With regards to PDS01ADC, we have completed enrollment in the metastatic colorectal cancer trial, and the advanced castration resistant prostate cancer trial continues to recruit well
Filing - Apr 15, 2026positive Published Stage 1 data (n=9) showed 77.8% ORR (7/9) at six months with PDS01ADC plus HAIP versus 35% in a parallel trial without PDS01ADC, with approximately 85% 24-month survival; no head-to-head comparison.
Objective response rate by RECIST v1.1: 77.8% (7/9) at six months; in the parallel trial without PDS01ADC, the ORR was 35% (7/20)
Filing
2 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 oncology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.