Enitociclib is under clinical development by Vincerx Pharma and currently in Phase I for Mantle Cell Lymphoma. According to GlobalData, Phase I drugs for Mantle Cell Lymphoma have a 74% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Enitociclib’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.

Enitociclib overview

Enitociclib is under development for the treatment of refractory solid tumor like tumor agnostic MYC aberrations, mantle cell lymphoma, follicular lymphoma, diffuse large B-cell lymphoma, hematological tumor, melanoma, primary mediastinal b-cell lymphoma, gastrointestinal tract cancer, endometrial cancer, ovarian cancer, triple-negative breast cancer, hormone refractory (castration resistant, androgen-independent) prostate cancer, Richter's syndrome (RS), non-Hodgkin’s lymphoma (NHL), burkitt lymphoma, double-hit diffuse large B-cell lymphoma (DH-DLBCL), multiple myeloma, endometrial, vulva, cervical cancer and various other hematological tumors. It is administered as an intravenous infusion. The drug candidate acts by targeting Cyclin Dependent Kinase 9 (CDK9).

It was also under development for the treatment of relapsed chronic lymphocytic leukemia (CLL), refractory chronic lymphocytic leukemia (CLL).

Vincerx Pharma overview

Vincera Pharma Inc (Vincera) is a clinical-stage biopharmaceutical company. It discovers and develops therapies for the treatment of cancer. The company’s pipeline product candidates include enitociclib, a CDK9 Inhibitor for MYC-rearranged DLBCL, and Non-GCB DLBCL and Peripheral T-cell Lymphoma. Vincera other pipeline includes VIP236 for the treatment of multiple solid tumors; VIP943, a KSP inhibitor against leukemia, VIP924, an antibody-drug conjugate to treat B-cell malignancies. The company is evaluating therapeutic programs for solid and hematologic tumors. It also utilizes its proprietary bio conjugate platform to develop therapies in the areas of oncology. Vincera is headquartered in Santa Clara, California, the US.

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

This content was updated on 7 February 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.