China-based biotechnology company ImmVira has received approval from the National Medical Products Administration (NMPA) for its potentially groundbreaking oncolytic virus product, MVR-C5252, which is under development to treat gliomas. This first-in-class product marks a significant step forward in the treatment of brain tumors.
Global Context and Precedence
In June 2021, Japanese firm Daiichi Sankyo’s Delytact received conditional time-limited approval to treat gliomas in Japan, becoming the world’s first oncolytic virus therapy for brain tumors. Building on this, ImmVira’s MVR-C5252, developed on its proprietary OvPENS platform, is specifically designed to target glioma cells. The product is genetically engineered to selectively eliminate malignant glial cells, ensuring safety while promoting an immune response within the tumor microenvironment.
Partnership and Orphan Drug Designation
In July of the previous year, ImmVira entered into a partnership with China Resources Biopharmaceutical Co., Ltd to exclusively collaborate on the development of MVR-C5252. This partnership was followed by the product receiving orphan drug designation (ODD) status in the US one month later, underscoring its potential impact on patients with rare diseases.
Clinical Collaboration with Duke University
ImmVira is also working in conjunction with Duke University on the clinical exploration of MVR-C5252, with a focus on convection-enhanced delivery (CED) as the administration approach. This collaboration aims to advance the understanding and application of MVR-C5252 in treating gliomas, offering hope for improved treatment options for patients.-Fineline Info & Tech
