MEDI-0457 is under clinical development by AstraZeneca 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 MEDI-0457’s likelihood of approval (LoA) and phase transition for Head And Neck Cancer Squamous Cell Carcinoma took place on 08 Dec 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their MEDI-0457 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

MEDI-0457 overview

MEDI-0457 (VGX-3100 plus DNA-based IL-12 cytokine) is under development for the treatment of HPV-caused head and neck squamous cell carcinoma (HNSCC), HPV positive oropharyngeal squamous cell carcinoma, cervical cancer, vulvar cancer, anal, penile cancer and vaginal cancer, newly diagnosed glioblastoma. It is administered intramuscularly by electroporation. INO-3112 is DNA-based combination immunotherapeutic composed of VGX-3100 DNA plasmids encoding the E6 and E7 genes of human papilloma virus (HPV) subtypes 16 and 18 combined with INO-9012, a DNA plasmid encoding interleukin-12 (IL-12). The vaccine is developed based on SynCon DNA vaccine technology, ASPIRE technology and CELLECTRA electroporation-based delivery technology. It was also under development for advanced unresectable or metastatic urothelial carcinoma.

AstraZeneca overview

AstraZeneca is a biopharmaceutical company, which is focused on discovery, production and commercialization of a range of prescription drugs. It develops products related to therapy areas such as respiratory, cardiovascular, renal and metabolic diseases, cancer, autoimmune, infection and neurological diseases. The company’s product portfolio includes biologics, prescription pharmaceuticals and vaccines. AstraZeneca sells its products through wholly-owned local marketing companies, distributors and local representative offices. The company markets its products to primary care and specialty care physicians. The COVID-19 Vaccine AstraZeneca has been approved for conditional marketing or emergency use. The company operates in Europe, the Americas, Asia, Africa and Australasia. AstraZeneca is headquartered in Cambridge, Cambridgeshire, the UK.

Quick View MEDI-0457 LOA Data

Report Segments
  • Innovator
Drug Name
  • MEDI-0457
Administration Pathway
  • Intramuscular
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: AstraZeneca
  • Originator: University of Pennsylvania
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.