Efineptakin alfa by Genexine for Recurrent Glioblastoma Multiforme (GBM): Likelihood of Approval

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.

Efineptakin alfa overview

Efineptakin alfa (GX-I7) is under development for the treatment of human papillomavirus infections, solid tumor including high grade glioma, recurrent glioblastoma and melanoma, triple negative breast cancer, high grade gliomas such as glioblastoma multiforme, gastrointestinal cancer, cervical intraepithelial neoplasia (CIN), triple-negative breast cancer, colorectal cancer, bile duct cancer, rectal, deuodenal cancer, small-cell lung cancer, ovarian cancer, pancreatic ductal adenocarcinoma, non-small cell lung cancer, squamous cell carcinoma, recurrent head and neck cancer squamous cell carcinoma including cytologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx, idiopathic CD4 lymphocytopenia, lymphocytopenia, sezary syndrome, unspecified B-Cell lymphomas, melanoma, merkel cell carcinoma, bladder cancer, colorectal cancer, breast cancer, acute radiation syndrome, acute lymphocytic leukemia, progressive multifocal leukoencephalopathy, gliosarcoma, and coronavirus (COVID-19). It is administered as mucosal delivery, through vaginal and as intramuscular routes as an injection. The drug candidate is an IL-7 and Fc fusion protein. It is developed based on hyFc or hybrid Fc platform. It was also under development for the treatment of relapsed/refractory gastric or gastro-esophageal junction or esophageal adenocarcinoma, head and neck cancer, anal cancer and non-small cell lung cancer as first line therapy.

Genexine overview

Genexine, formerly Genexine, is a clinical-stage biotechnology company that develops and commercializes immunotherapeutics and next-generation novel long-acting biologics. The company also develops therapeutic vaccines for incurable diseases and next-generation antibody fusion protein drugs. Its pipeline products include GX-H9, GX-G8, rhIL-7-hyFc, GX-G3, GX-G6, HPV DNA Vaccine and IL-7-hyFc. Genexine develops products for various therapeutic areas such as orphans, cancers and also immune disorders. The company uses hybrid Fc technology platform for the discovery of a wide range of differentiated agonistic protein therapeutics. It partners with other pharmaceutical companies for its research and development activities. The company has operations in the US and South Korea. Genexine is headquartered in Seongnam, South Korea

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

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.