NantCell receives FDA orphan drug status for Ganitumab Monoclonal Antibody Therapy in Ewing Sarcoma
Release Date: 18-Apr-2017
NantCell, Inc., part of the NantWorks ecosystem of companies, has been granted orphan drug designation from US Food and Drug Administration (FDA) for the company’s Ganitumab, Insulin Growth Factor-1R (IGF-1R) Monoclonal Antibody Therapy for the treatment of Ewing Sarcoma. Ganitumab is a fully human monoclonal antibody directed against IGF-1R that is being investigated in a Phase III human clinical trial.
Mechanism of action of the monoclonal antibody is described as IGF-1R plays a role in the development and progression of many cancers, possibly due to its anti-apoptotic properties, which allow cancerous cells to resist the cytotoxic properties of chemotherapeutic drugs or radiation therapy. Ganitumab inhibits cancer cell proliferation through disruption of the P13K/Akt and MAPK pathways. Signaling through IGF-1R plays an important role in the regulation of cell growth and survival, and has been shown to be a critical promoter of anchorage independent growth, a well-recognized mechanism for malignancy.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and andmdash; upon regulatory approval andmdash; 7 years of market exclusivity.
“Global Orphan Drug Clinical Pipeline Insight” reports by kuick research gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase.
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