PDS Biotechnology
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2005-01-01
- Employees
- 25
- Market Cap
- $114.8M
- Website
- http://www.pdsbiotech.com
- Introduction
PDS Biotechnology Corp. engages in the development of clinical-stage immunotherapies to treat various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its product, PDS0101, is an off the shelf immunotherapeutic that is administered by subcutaneous injection. The company was founded by Frank K. Bedu-Addo in 2005 and is headquartered in Princeton, NJ.
Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- Conditions
- Recurrent Head and Neck CancerMetastatic Head and Neck CancerHPV Positive Oropharyngeal Squamous Cell CarcinomaNeoplasms, Head and NeckUnresectable Head and Neck Squamous Cell Carcinoma
- Interventions
- Combination Product: Combination Treatment of PDS0101 and Pembrolizumab
- First Posted Date
- 2025-01-24
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- PDS Biotechnology Corp.
- Target Recruit Count
- 351
- Registration Number
- NCT06790966
- Locations
- 🇺🇸
Mayo Clinic Arizona, Phoenix, Arizona, United States
🇺🇸Marin Cancer Care, Greenbrae, California, United States
🇺🇸Mayo Clinic Florida, Jacksonville, Florida, United States
Study of PDS0101 and Pembrolizumab Combination I/O in Subjects with HPV16 + Recurrent And/or Metastatic HNSCC
- Conditions
- Metastatic Head and Neck CancerHPV Positive Oropharyngeal Squamous Cell CarcinomaNeoplasms, Head and NeckRecurrent Head and Neck Cancer
- Interventions
- Combination Product: Pembrolizumab (KEYTRUDA®) and PDS0101
- First Posted Date
- 2020-02-07
- Last Posted Date
- 2025-03-25
- Lead Sponsor
- PDS Biotechnology Corp.
- Target Recruit Count
- 95
- Registration Number
- NCT04260126
- Locations
- 🇺🇸
Cleveland Clinic Florida, Weston, Florida, United States
🇺🇸University of Kentucky Chandler Medical Center - Markey Cancer Center, Lexington, Kentucky, United States
🇺🇸University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101
- Conditions
- High-risk HPV Infection and Biopsy-proven CIN1
- Interventions
- Biological: R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7
- First Posted Date
- 2014-02-19
- Last Posted Date
- 2018-12-13
- Lead Sponsor
- PDS Biotechnology Corp.
- Target Recruit Count
- 12
- Registration Number
- NCT02065973
- Locations
- 🇺🇸
Suffolk Obstetrics & Gynecology, Port Jefferson, New York, United States
🇺🇸Montefiore Medical Center, Bronx, New York, United States