PDS-0101 is a Subunit Vaccine owned by PDS Biotechnology, and is involved in 8 clinical trials, of which 3 were completed, and 5 are ongoing.

PDS-0101 acts by activating the immune system and inducing production of T-cells and important immune chemicals, known as cytokines and chemokines, needed to produce and activate the T-cells by activating an immune signaling pathway known as the MAP kinase pathway. The vaccine candidate elicits therapeutic effect by inducing an immune response to disease associated proteins or peptides.

The revenue for PDS-0101 is expected to reach a total of $2.2bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the PDS-0101 NPV Report.

PDS-0101 is originated and owned by PDS Biotechnology.

PDS-0101 Overview

PDS-0101 is under development for the treatment of HPV-induced cancers which includes cervical intraepithelial neoplasia (cervical dysplasia). It is administered through subcutaneous route. It targets HPV-16. The drug candidate contains Versamune nanoparticles and multiple short HPV strain-16 viral proteins. The drug candidate is developed by Versamune nanotechnology platform. Versamune nanotechnology facilitates efficient processing of the disease related protein and its presentation to the T-cells of the immune system.

It is also under development for the treatment of human papillomavirus z (hpv) infection related head and neck cancer, HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). anal cancer, hpv associated vulvar cancer, vaginal cancer, penile cancer, cervical cancer, oropharyngeal cancer, squamous cell rectal cancers, lung cancer, esophageal cancer and oropharyngeal cancer.

PDS Biotechnology Overview

PDS Biotechnology is a biopharmaceutical company that develops vaccines and immunotherapies for cancer and infectious disease. It is investigating PDS0101 for the treatment of head and neck, HPV-positive anal, cervical, penile, vaginal, vulvar cancers, and pre-metastatic HPV-associated oropharyngeal cancer (OPSCC); PDS-0201 to prevent tuberculosis; PDS0202 targeting influenza; and PDS0203 against COVID-19. The company is also evaluating PDS0102 for TARP-associated AML (acute myeloid leukemia), prostate and breast cancers; PDS0103 against MUC1-associated breast, colon, lung, ovarian and other cancers; and PDS0104 to treat melanoma. It utilizes Versamune and Infectimune, T-cell immune activating platform technologies. PDS Biotechnology is headquartered in Princeton, New Jersey, the US.

The operating loss of the company was US$21.4 million in FY2021, compared to an operating loss of US$14.9 million in FY2020. The net loss of the company was US$16.9 million in FY2021, compared to a net loss of US$14.9 million in FY2020.

Quick View – PDS-0101

Report Segments
  • Innovator
Drug Name
  • PDS-0101
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Oncology
  • Women’s Health
Key Companies
Highest Development Stage
  • Phase II

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.