On March 29, 2023 ImmVira reported that its oncolytic virus product MVR-C5252 targeting malignant glioma obtained the approval from National Medical Products Administration ("NMPA") for Phase I clinical trial in China on March 29, 2023 (Press release, Immvira, MAR 29, 2023, View Source [SID1234629510]). Previously, MVR-C5252 also obtained Orphan Drug Designation from U.S. Food and Drug Administration in August 2022.
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In July 2022, the Company entered into a cooperative agreement with China Resource Biopharma ("CRBio") to jointly develop MVR-C5252 in the Greater China area, leveraging CRBio’s rich clinical resources to accelerate clinical progress. The Company is also planning to jointly carry out clinical research on MVR-C5252 with Duke University in the U.S., and for the first time to use Convection Enhanced Delivery ("CED") as the administration method. Diversified cooperation modes not only reflect the recognition of ImmVira’s oncolytic virus products by well-known domestic and foreign pharmaceutical companies and leading scientific research institutions, but also facilitate the Company’s clinical development in both China and the U.S., striving to provide new treatment options for tumor patients as soon as possible.
Malignant glioma has a poor prognosis with a high recurrence rate of nearly 100% and a median survival time of only 1.5 years, creating urgent needs for a more effective treatment option. Developed on ImmVira’s OVPENS (Open Vector + Potent, Enabling, Novel & Safe) platform, MVR-C5252 is designed specifically for the treatment of central nervous system tumors. This product has been further precisely attenuated to achieve on-target malignant gliocyte killing while maintaining safety profile; and the product also carries specific therapeutic exogenous genes to promote the immune response of tumor microenvironment for further anti-tumor activity. On June 11, 2021, Daiichi Sankyo Company, Limited’s oncolytic therapy Delytact received conditional and time-limited approval from the Ministry of Health, Labour and Welfare of Japan (MHLW), for the treatment of malignant glioma, becoming the world’s first OV therapy approved for brain tumors and another strong validation of HSV-1 modality.