GEN-001 is under clinical development by Genome & Co and currently in Phase II for Extrahepatic Bile Duct Cancer. According to GlobalData, Phase II drugs for Extrahepatic Bile Duct Cancer 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 GEN-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.

GEN-001 overview

GEN-001 is under development for the treatment of solid tumors including non-small cell lung cancer, head and neck squamous cell carcinoma, gastric and gastroesophageal junction adenocarcinoma, urothelial carcinoma, metastatic advanced biliary tract adenocarcinoma of the gallbladder or biliary tree (either intrahepatic or extrahepatic cholangiocarcinoma) and unspecified cancers. It is being developed as an oral enteric capsule containing lyophilized bacteria. The drug candidate is a single strain microbiome.

It was under development for the treatment of non-small lung cancer, melanoma, locally advanced rectal cancer and bladder cancer.

Genome & Co overview

Genome & Co (G&C) is a research and development company that focusses on researching microbes and probiotics, and developing dietary supplements, cosmeceuticals and novel medicines. Its pipeline products include GEN-001, a single strain microbiome for treating NSCLC (Non-Small Cell Lung Cancer), melanoma, and bladder cancer; GENI-401 against infertility; GEND-EX02 for enhancing of innate and adaptive immune system; GENS-501 for treating atopic dermatitis; GENS-502 indicated for Acne; and immuno-oncology supplements. Its technology and capabilities enables to identify the cause of the disease, integrates the functional mechanism using a simulator of the human colon microbial ecosystem and multi-omics profiling through next generation sequencing techniques. The company seeks to work in partnership with hospitals, research institutes and government organizations for market driven product development and licensing opportunities. G&C is headquartered in Seongnam, Gyeonggi, South Korea.

For a complete picture of GEN-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.