PDS-0101 is under clinical development by PDS Biotechnology and currently in Phase II for Recurrent Head And Neck Squamous Cell Carcinoma. According to GlobalData, Phase II drugs for Recurrent Head And Neck Squamous Cell Carcinoma have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how PDS-0101’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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 Florham Park, New Jersey, the US.

For a complete picture of PDS-0101’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.