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.
Clinical Trials
3
Trial Phases
3 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
This company may not have drug approvals in our database
Clinical Trials
Distribution across different clinical trial phases (3 trials with phase data)• Click on a phase to view related trials
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
- 2025-07-30
- Lead Sponsor
- PDS Biotechnology Corp.
- Target Recruit Count
- 351
- Registration Number
- NCT06790966
- Locations
- 🇺🇸
University of Virginia Health System, Charlottesville, Virginia, United States
🇺🇸Mayo Clinic Arizona, Phoenix, Arizona, United States
🇺🇸Marin Cancer Care, Greenbrae, California, 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
- 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
- 🇺🇸
Marin Cancer Center, Greenbrae, California, United States
🇺🇸University of California San Francisco, San Francisco, California, United States
🇺🇸Mayo Clinic, Rochester, Minnesota, 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
- 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
- 🇺🇸
Montefiore Medical Center, Bronx, New York, United States
🇺🇸Suffolk Obstetrics & Gynecology, Port Jefferson, New York, United States
News
PDS Biotechnology Secures $11 Million in Latest Funding Round
PDS Biotechnology, a portfolio company of EMV Capital, has successfully raised $11 million in new funding to advance its biotechnology initiatives.
PDS Biotech's VERSATILE-003 Phase 3 Trial for HPV16-Positive Head and Neck Cancer to Initiate Q1 2025
PDS Biotech reaffirms its plan to initiate the VERSATILE-003 Phase 3 trial in Q1 2025, evaluating Versamune HPV plus pembrolizumab for recurrent/metastatic HPV16-positive head and neck cancer.
PDS Biotech's Versamune HPV Shows Promise in HPV16-Positive Cancers, Phase III Trial Planned
PDS Biotechnology's VERSATILE-003 Phase III trial, evaluating Versamune HPV with pembrolizumab, is set to begin in early 2025, with interim data expected six months after enrollment completion.
PDS Biotech's PDS0101 and Keytruda Combination Therapy to Enter Phase 3 Trial for HPV16-Positive Cancers
PDS Biotechnology is set to initiate the VERSATILE-003 Phase 3 trial in Q1 2025, evaluating the combination of PDS0101 and Keytruda.
PDS Biotech Updates Phase 3 VERSATILE-003 Trial Design for HPV16-Positive HNSCC
PDS Biotechnology has updated the Phase 3 VERSATILE-003 trial design for HPV16-positive recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC), increasing the patient target to approximately 350.
PDS Biotech Reports Q3 2024 Results, Highlights VERSATILE-003 Trial Progress
PDS Biotechnology Corp reported a net loss of $10.7 million in Q3 2024, slightly better than the $10.8 million loss in Q3 2023, with revenue in line with expectations.
PDS Biotech Announces Clinical Program Updates and Q3 2024 Financial Results
PDS Biotech is advancing the VERSATILE-003 Phase 3 trial of Versamune HPV + pembrolizumab for recurrent/metastatic HPV16-positive head and neck squamous cell cancer (HNSCC).
PDS Biotech to Announce Third Quarter Financial Results and Clinical Program Update
PDS Biotech will release its financial results for the quarter ending September 30, 2024, offering insights into its financial performance and strategic initiatives.
PDS Biotech Presents Trial Design of PDS01ADC Plus Enzalutamide for Recurrent Prostate Cancer
PDS Biotech presented the rationale and design for a clinical trial evaluating PDS01ADC in combination with enzalutamide for recurrent prostate cancer.
PDS Biotech's PDS0101 Shows Promising Survival Data in Advanced Cervical Cancer Trial
PDS Biotechnology's IMMUNOCERV trial shows an 84.4% overall survival rate at 36 months for advanced cervical cancer patients treated with PDS0101 and chemoradiation.