GRANITE-001 is under clinical development by Gritstone Bio and currently in Phase III for Metastatic Colorectal Cancer. According to GlobalData, Phase III drugs for Metastatic Colorectal Cancer have a 49% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how GRANITE-001’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.

GRANITE-001 overview

GRANITE-001 (Zvexneo) is under development for the treatment of pancreatic ductal adenocarcinoma, microsatellite stable colorectal cancer, metastatic non-small cell lung cancer, gastroesophageal adenocarcinoma, bladder cancer such as metastatic urothelial cancer. The drug candidate is a individualized, heterologous chimpanzee adenovirus (ChAd68) and self-amplifying mRNA (samRNA)-based neoantigen vaccine administered through intramuscular route. It is developed based on Edge neoantigen platform, lipid nanoparticle (LNP) technology, and ZVex platform.
It was also under development for colon cancer.

Gritstone Bio overview

Gritstone Bio carries out the discovery, development, manufacture and deliver of the cancer and infectious disease immunotherapy candidates. The company product candidate comprises GRT-R910 (samRNA), GRT-C907(ChAd)/-R908 (samRNA), GRT- C909 (ChAd)/- R910(samRNA), GRT-R914 (samRNA), GRT-R912 (samRNA) and GRT-R918 (samRNA). Its infectious diseases pipeline includes coral, a second-generation COVID-19 vaccine program and HIV therapeutic vaccine candidate. Gritstone Bio’s oncology programs comprise granite, an individualized neoantigen-based immunotherapy and slate, to treat non-small cell lung cancer. It also provides Gritstone edge an artificial intelligence and vaccine platforms to predict the tumor-specific neoantigens. The company also carries out the research and development activities and clinical trials. The company operate in Massachusetts and California, the US. Gritstone Bio is headquartered in Emeryville, California, the US.

For a complete picture of GRANITE-001’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 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.