DCVax-Direct is under clinical development by Northwest Biotherapeutics and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect DCVax-Direct’s likelihood of approval (LoA) and phase transition for Bile Duct Cancer (Cholangiocarcinoma) took place on 31 May 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their DCVax-Direct Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

DCVax-Direct overview

DCVax-direct is under development for the treatment of solid tumors, metastatic  cholangiocarcinoma and bladder cancer. The vaccine candidate is administered as an intratumoral injection. It comprises of autologous and activated dendritic cells and specific tumor-related proteins or antigens that induce a specific immune response against cancer cells. The vaccine candidate is developed through DCVax technology. It was also under development for non-small cell lung cancer, liver cancer, colorectal cancer, pancreatic cancer, melanoma, ovarian cancer, soft tissue sarcoma, head and neck cancer, neuroendocrine tumors,  colon cancer and breast cancer with brain metastases.

Northwest Biotherapeutics overview

Northwest Biotherapeutics (NW Bio) is a development-stage biotechnology company. It discovers and develops immunotherapy products to treat cancer. The company uses its proprietary technology platform, DCVax to develop therapeutic product candidates. DCVax is a personalized immune therapy and consists of therapeutic vaccine which uses patient’s own dendritic cells as the therapeutic agent. NW Bio’s product lines include DCVax-L, for the treatment of glioblastoma multiforme (GBM), brain cancer; DCVax-Direct, for the treatment of all inoperable solid tumor cancers; and DCVax-Prostate, for the treatment of late-stage prostate cancer. NW Bio is headquartered in Bethesda, Maryland, the US.

Quick View DCVax-Direct LOA Data

Report Segments
  • Innovator
Drug Name
  • DCVax-Direct
Administration Pathway
  • Intratumor
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase II


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

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.