FR-104 is under clinical development by OSE Immunotherapeutics and currently in the Phase I and 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 FR-104’s likelihood of approval (LoA) and phase transition for Stem Cell Transplantation took place on 01 Apr 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.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their FR-104 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

FR-104 overview

FR-104 is under development for the treatment of autoimmune disorders including, rheumatoid arthritis, multiple sclerosis, psoriasis, uveitis, graft versus host disease (GVHD) and prevention of transplantation rejection including kidney transplantation and stem cell transplantation. It is administered intravenously and subcutaneously. It is a monovalent pegylated Fab fragment of a humanised anti-CD28 monoclonal antibody. The drug candidate is a new molecular entity (NME).

OSE Immunotherapeutics overview

OSE Immunotherapeutics (OSE) is a biotechnology company that discovers and develops immunotherapy products against invasive and metastatic late-stage cancers. The company’s memopi technology is employed in studying the development of treatments for ovarian, colon, and breast cancer. It provides products such as tedopi and effi-7. OSE’s Effi-7 is in preclinical development and targets autoimmune diseases and transplantation. OSE’s tedopi stimulates cytotoxic killer T cells and relearns them to detect cancer cells to eliminate them. The company offers pipeline products such as OSE-172, OSE-703, FR104, and 0SE-127. It markets its products through its distribution network. OSE is headquartered in Nantes, Pays-de-la-Loire, France.

Quick View FR-104 LOA Data

Report Segments
  • Innovator
Drug Name
  • FR-104
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Central Nervous System
  • Hormonal Disorders
  • Immunology
  • Ophthalmology
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.