On March 29, 2023, ImmVira announced 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. Previously, MVR-C5252 was granted orphan drug qualification by the U.S. Food and Drug Administration in August 2022. OBiO Technology would like to express its heartfelt congratulations to its partners for their important progress.
Relevant Reading：【Customer Dynamics】Congratulation | The product MVR-C5252 from ImmVira, a new oncolytic virus product targeting glioma, has been granted "orphan drug" designation by the US FDA.
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, Labor 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.
Original link of News details：ImmVira's oncolytic product MVR-C5252 targeting malignant glioma obtained NMPA's approval for Clinical Trial in China
About ImmVira
ImmVira is a biotechnology company focused on developing and synthesizing biological vector delivery platform. The company has constructed a fully integrated OVPENS (Open Vector+ Potent, Enabling, Novel & Safe) platform with solid science, technology and CMC know-how, and three derivative subplatforms including Oncolytic Virus, Cancer Vaccine and Biosynthetic Exosome, to support ongoing R&D, clinical studies and commercialization of best-in-class mono and combo therapies driven by clinical benefits in oncology and non-oncology fields.
About OBiO Technology
OBiO Technology (Shanghai) Corp., Ltd. (OBiO, 688238.SH) is a gene and cell therapy-focused CRO and CDMO founded in 2013. In China for global customers, we offer holistic research, development, and manufacturing solutions for vectorology studies, functional genomics, process and analytical development, IND-enabling CMC, clinical and commercial manufacturing. With "enable gene therapy for better lives" as our mission, we are committed to providing high-quality service to global customers, advancing your product from bench to clinic, and bringing benefit to populations around the world. For more information about OBiO Technology, visit www.obio-tech.com.