NIU-440 is under clinical development by Novartis and currently in the Phase I 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 NIU-440’s likelihood of approval (LoA) and phase transition for Peritoneal Cancer took place on 17 Nov 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 NIU-440 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

NIU-440 overview

NIU-440 is under development for the treatment of metastatic breast cancer, metastatic pancreatic adenocarcinoma, persistent or recurrent serious epithelial ovarian cancer or primary peritoneal carcinoma, malignant pleural/peritoneal mesothelioma, lung adenocarcinoma and fallopian tube carcinoma. The therapeutic candidate is administered through intravenous and intrapleural routes. It comprises of autologous T cells lentivirally transduced with chimeric anti-mesothelin immunoreceptor SS1 fused to the 4-1BB and CD3 signaling domains.

Novartis overview

Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.

Quick View NIU-440 LOA Data

Report Segments
  • Innovator
Drug Name
  • NIU-440
Administration Pathway
  • Intrapleural
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: Novartis
  • Originator: University of Pennsylvania
Highest Development Stage
  • Phase I

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.