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Gradalis, Inc. Announces FDA Designation for Vigil® (Gemogenovatucel-T) as a Personalized Immunotherapy for Advanced Ovarian Cancer

Feb 05, 2025
DallasBiotechnologyHealth CareTherapeutics

Product Description

Gradalis, Inc. has secured Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for its investigational personalized immunotherapy, Vigil® (Gemogenovatucel-T), based on positive results from the Phase 2b VITAL trial. This designation is aimed at facilitating the development of Vigil as a maintenance treatment for advanced ovarian cancer patients.

Company Information

Company

Gradalis

Location

Dallas, Texas, United States

About

Gradalis is a late-stage clinical biotechnology company developing immunotherapies for multiple cancer indications including an upcoming Phase 3 registration trial in patients with ovarian cancer. The company’s proprietary bi-shRNA therapy platform, which has been proven in its clinical studies, can be utilized to silence a broad range of genes and is applicable to multiple cancer types.

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