Tinostamustine is under clinical development by Mundipharma EDO and currently in Phase II for Endometrial Cancer. According to GlobalData, Phase II drugs for Endometrial Cancer have a 22% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Tinostamustine’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Tinostamustine overview

Tinostamustine (NL-101) is under development for the treatment of hematological malignancies and solid tumors including glioblastoma multiforme (GBM), sarcomas, breast cancer, triple negative breast cancer, endometrial cancer, soft tissue sarcoma (STS) or non-KIT gastrointestinal stromal tumors (GIST), small cell lung cancer, acute myelocytic leukemia, advanced cutaneous T-cell lymphoma (either mycosis fungoides [MF] or Sezary syndrome [SS]), multiple myeloma, mantle cell lymphoma, diffuse large B-cell lymphoma and epithelial ovarian cancer, primary peritoneal cancer,T-cell prolymphocytic leukemia and fallopian tube cancer. The therapeutic candidate is administered by intravenous and parenteral route. NL-101 is a hybrid fusion molecule in which the side chain of bendamustine was replaced with the hydroxamic acid of HDACi vorinostat (SAHA). It has a bendamustine back-bone and a histone deacetylase (HDAC) pharmacophore. The drug candidate targets DNA and histone deacetylase. It is developed based on dual functional cytotoxic targeted therapy (DCTT) technology.

It was under development for relapsed/refractory multiple myeloma, relapsed and refractory cutaneous T-cell lymphoma, Hodgkin lymphoma, peripheral T-cell lymphomas.

For a complete picture of Tinostamustine’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.