Azercabtagene zapreleucel is under clinical development by Imugene and currently in Phase II for Primary Mediastinal B-Cell Lymphoma. According to GlobalData, Phase II drugs for Primary Mediastinal B-Cell Lymphoma have an 82% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Azercabtagene zapreleucel’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.

Azercabtagene zapreleucel overview

Azercabtagene zapreleucel (PBCAR-0191) is under development for the treatment of graft vs host disease, relapsed or refractory B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma including diffuse large B cell lymphoma, follicular lymphoma, primary mediastinal B-cell lymphoma, mantle cell lymphoma, small lymphocytic lymphoma, high grade B cell lymphoma and autoimmune disorders. It is administered through intravenous route. The therapeutic candidate constitutes of allogenic anti-CD19 chimeric antigen receptor (CAR) T cells. It is developed based on the ARCUS technology platform. It is a genome editing platform derived from a natural genome editing enzyme called homing endonuclease which incorporates Adeno-associated virus (AAV) vector. It acts by targeting cells expressing the CD19 protein.

Imugene overview

Imugene is a clinical-stage biopharmaceutical company that focuses on the development of vaccines in the area of oncology. The company develops immunotherapies that activate the immune system of cancer patients to identify and eradicate tumors. The company develops products for the treatment of various tumors including gastric, breast, lung cancers. Imugene’s lead product candidate, CF33 is a chimeric vaccinia poxvirus for the treatment of mixed advanced solid tumors (MAST) and metastatic triple-negative breast cancer. It develops vaccine candidates based on Mimotope technology, which uses peptide mimics of conformational epitopes recognized by an antibody with antitumor activity. Imugene is headquartered in Sydney, New South Wales Australia.

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

This content was updated on 22 January 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.