GRANITE-001 is under clinical development by Gritstone Bio and currently in Phase II for Pancreatic Ductal Adenocarcinoma. According to GlobalData, Phase II drugs for Pancreatic Ductal Adenocarcinoma does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the GRANITE-001 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.

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 personalized cancer 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 (Gritstone), formerly Gritstone Oncology, is a clinical-stage biotechnology company. The company discovers, develops, manufactures, and delivers vaccine-based immunotherapy candidates against cancer and infectious diseases. It develops personalized cancer vaccines designed to direct a robust immune response to neoantigens by leveraging its artificial intelligence Gritstone EDGE platform. Gritstone’s cancer vaccines product pipeline includes GRANITE and SLATE for solid tumors; and prophylactic samRNA (CORAL), HIV Therapeutic vaccine, and other flu, multi-respiratory, papillomavirus (HPV) eradication pathogens. The company designs immunotherapy containing the relevant neoantigens to be administered by intramuscular injection. It manufactures products through its biomanufacturing facilities in Massachusetts, and California, the US. Gritstone 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 10 June 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.