Zedenoleucel is under clinical development by Marker Therapeutics and currently in Phase I for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia). According to GlobalData, Phase I drugs for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia) have a 70% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Zedenoleucel’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.

Zedenoleucel overview

zedenoleucel (MT-401) is under development for the treatment of acute myelocytic leukemia, acute lymphoblastic leukemia, pancreatic cancer and myelodysplastic syndrome. The therapeutic candidate is administered as intravenous infusion. The cellular immunotherapy constitutes donor derived multi tumor associated antigen (TAA)-specific T cells which act by targeting cancer cells which express WT1, PRAME, NY-ESO-1, Survivin tumor associated antigens. It is administered as an intravenous infusion.

It was under development for the treatment of relapsed or refractory acute myeloid leukemia, sarcoma, breast cancer, lymphoma and ovarian cancer.

Marker Therapeutics overview

Marker Therapeutics is a clinical-stage immuno-oncology company that carries out the development and commercialization of novel T cell-based immunotherapies and innovative peptide-based vaccines for the treatment of hematological malignancies and solid tumor indications. The company’s pipeline products include MT-401, which is used for the treatment of post-transplant AML and MT-601, which is used for the treatment of advanced unresectable pancreatic cancer. It also provides Multi-Antigen Targeted (MultiTAA) technology that utilizes a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s blood. Marker Therapeutics carries out several clinical studies including acute myeloid leukemia, non-Hodgkin’s lymphoma, multiple myeloma and breast cancer. Marker Therapeutics is headquartered in Houston, Texas, the US.

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

This content was updated on 20 May 2024

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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 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.