Flucytosine ER + vocimagene amiretrorepvec is under clinical development by Denovo Biopharma and currently in Phase I for High-Grade Glioma. According to GlobalData, Phase I drugs for High-Grade Glioma does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Flucytosine ER + vocimagene amiretrorepvec LoA Report. 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.
Flucytosine ER + vocimagene amiretrorepvec overview
Toca 511 (vocimagene amiretrorepvec) and flucytosine (5-FC) combination regimen is under development for the treatment of brain metastasis from anaplastic oligodendroglioma, non-muscle invasive bladder cancer and newly diagnosed high grade glioma (HGG). Toca 511 is administered through a stereo tactic transcranial, intratumoral, intracranial, intravenous and 5-FC is administered orally. Flucytosine is deaminated to cytotoxic drug 5-fluorouracil (5-FU). Toca 511 is a prodrug activator that is based on controlled active gene transfer technology (CAGT) platform. The CAGT platform is a Retroviral Replicating Vector (RRV) that carries the complete complement of viral genes (gag, pol, env) which allow viral replication and subsequent delivery of a therapeutic gene throughout a tumor. The CAGT platform delivers high concentrations of anti-cancer drug, 5-fluorouracil selectively target the cancer cells while sparing healthy tissue and may produce the therapeutic effect.
The drug combination is under development for the treatment of high grade glioma, melanoma, pancreatic, lung and breast cancer. It was also under development for recurrent glioblastoma multiforme (GBM), recurrent anaplastic astrocytoma, triple negative breast cancer, non-small cell lung cancer, head and neck cancer, ovarian cancer, lymphoma, sarcoma, colorectal cancer and bladder cancer.
Denovo Biopharma overview
Denovo Biopharma is a clinical-stage biopharmaceutical company focused on the development of biomarker-driven precision medicines. Its pipeline products include DB104 for depression; DB103 targets schizophrenia; DB105 and DB109 which treats alzheimer’s disease; DB103 for glioblastoma multiforme (GBM); DB106 treats acute myelogenous leukemia (AML); DB108 for non-small cell lung cancer (NSCLC). The company’s therapeutic areas include oncology, neurology, metabolic, cardiology, and immunology. It has operations in the US and China. Denovo Biopharma is headquartered in San Diego, California, the US.
For a complete picture of Flucytosine ER + vocimagene amiretrorepvec’s drug-specific PTSR and LoA scores, buy the report here.
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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.
