Nerofe is under clinical development by Immune System Key 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 Nerofe’s likelihood of approval (LoA) and phase transition for Refractory Acute Myeloid Leukemia took place on 24 Oct 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 24 Oct 2022 increased Nerofe’s LoA and PTSR for Relapsed Acute Myeloid Leukemia.

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

Nerofe overview

Nerofe is under development for the treatment of advanced malignancies, pancreatic cancer, myelodysplastic syndrome, Alzheimer''s disease and relapsed and refractory acute myelocytic leukemia (AML). The drug candidate is administered by intravenous route as an infusion. It is a derivative of the human hormone-peptide tumor-cells apoptosis factor (TCApF). It contains 14 amino-acids. The drug candidate acts by targeting IL1RL1. It was under development for the treatment of renal cell carcinoma, metastatic ovarian cancer, triple negative breast cancer, metastatic colorectal carcinoma, metastatic solid tumors.

Immune System Key overview

Immune System Key (ISK) is a drug discovery and development company. It offers treatments for malignant and autoimmune diseases with unmet needs. The company provides lead compound such as Nerofe, the US Food and Drug Administration approved orphan drug for the treatment of AML. In addition, It also offers assets which are based on human secreted peptides. ISK provides Nerofe which is in preparation for phase IIa. ISK has several peptides and derivatives of natural human proteins which possess anti-cancer properties and the ability to regenerate several types of white blood cells. The company holds various patents on the molecule and applications. ISK is headquartered in Jerusalem, Israel.

Quick View Nerofe LOA Data

Report Segments
  • Innovator
Drug Name
  • Nerofe
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Central Nervous System
  • Oncology
Key Developers
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.