Fimepinostat is under clinical development by Curis 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 Fimepinostat’s likelihood of approval (LoA) and phase transition for Hodgkin Lymphoma (B-Cell Hodgkin Lymphoma) took place on 18 Dec 2020, 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 18 Dec 2020 increased Fimepinostat’s Phase Transition Success Rate (PTSR) for CNS Lymphoma, increased LoA and PTSR for Neuroblastoma, increased PTSR for NUT Midline Carcinoma (NMC or Nuclear Protein in Testis Midline Carcinoma), and increased PTSR for Ovarian Cancer.

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

Fimepinostat overview

Fimepinostat (CUDC-907) is under development for the treatment of newly diagnosed diffuse intrinsic pontine glioma (DIPG), recurrent medulloblastoma, recurrent high-grade glioma (HGG), refractory or relapsed lymphomas such as Hodgkin lymphoma, diffuse large B-cell lymphoma, high-grade B-cell lymphoma, transformed follicular lymphoma, Burkitt lymphoma, solid tumors, NUT midline carcinoma, hormone receptor-positive breast cancer, triple-negative breast cancer, high-grade serous ovarian cancer, CNS tumors or lymphoma including neuroblastoma. The drug candidate is administered orally. It is a multi-targeted synthetic small molecule. CUDC-907 is a dual inhibitor of class I and IIB histone deacetylase or HDAC enzymes and alpha, delta and beta isoforms of phosphoinositide 3-kinase. It was also under development for the treatment of thyroid cancers including anaplastic or undifferentiated thyroid cancer, poorly differentiated thyroid cancer, hurthle cell carcinoma, tall-cell variant of papillary thyroid cancer and a sclerosing variant of papillary thyroid cancer.

Curis overview

Curis is a biotechnology company that focuses on developing and commercializing novel drug candidates for treating cancers with substantial unmet medical need. The company’s lead product Erivedge has been developed in collaboration with F. Hoffmann-La Roche Ltd and Genentech, which is commercialized for the treatment of advanced basal cell carcinoma (BCC). The product is approved for use in patients with advanced BCC in the US, European Union (EU), Australia and several other countries.

Quick View Fimepinostat LOA Data

Report Segments
  • Innovator
Drug Name
  • Fimepinostat
Administration Pathway
  • Oral
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.