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: Interim readout, biochemically recurrent prostate cancer (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: PDS0301 — Interim readout, biochemically recurrent prostate cancer (Q4 2026). 16 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
- Sep 30, 2026n/a Dr. Patrick Soon-Shiong joined the Board of Directors following September 2026 financing led by Nant Capital.
Following a September 2026 financing led by Nant Capital, Dr. Patrick Soon-Shiong joined the Board of Directors, bringing prior experience obtaining FDA approval for an immunocytokine.
Filing - Sep 30, 2026n/a PDS Biotechnology completed a financing led by Nant Capital in September 2026.
Following a September 2026 financing led by Nant Capital, Dr. Patrick Soon-Shiong joined the Board of Directors.
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
7 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
- Tango Therapeutics, Inc. TNGX
- Tyra Biosciences, Inc. TYRA
- Verastem, Inc. VSTM
- Obsidian Therapeutics, Inc. OBX
- Puma Biotechnology, Inc. PBYI
- Fulgent Genetics, Inc. FLGT
- Delcath Systems, Inc. DCTH
- Unknown Unknown
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.