ImmVira's MVR-C5252 Targeting Brain Tumor Obtained US FDA's Approval for Clinical Trial
SHENZHEN, China, Aug. 8, 2021 /PRNewswire/ -- ImmVira announces MVR-C5252 targeting Glioblastoma has received the U.S. FDA clearance to proceed with clinical trial on August 6, 2021.
Glioma is the most common type of CNS tumors. Glioblastoma ("GBM"), as the most aggressive type of Gliomas, displays the highest grade of malignancy and can occur in the brain or spinal cord with median survival of less than two years. The lack of availability in treatment therapies except surgery and radiation, especially the limited options of drugs, indicate an urgent need for development of a novel therapeutic strategy, particularly for recurrent GBM.
On June 11, 2021, Daiichi Sankyo Company, Limited announced that it has received conditional and time-limited approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for DELYTACT® (teserpaturev/G47∆), an oncolytic virus("OV"), for the treatment of patients with GBM, becoming the world's first OV therapy approved for brain tumors. The approval of DELYTACT in Japan is a validation of oHSV-1 modality. Moreover, FDA's approval on Breakthrough Therapy Status of two OV products targeting GBM in recent years symbolizes the favorable forward-looking for OV modalities over the same indication.
Leveraging ImmVira's OvPENS development platform, MVR-C5252 is designed specifically for the treatment of malignant glioma. This product has been further genetically engineered on the basis of MVR-T3011 (also known as T3011) by specific attenuation to achieve on-target malignant gliocyte killing while maintaining safety profile. MVR-C5252 also carries exogenous genes that express IL-12 and PD-1 mAb to promote the immune response of tumor microenvironment for further anti-tumor activity.
The IND clearance of MVR-C5252 in the United States highlights ImmVira's strong and sustainable research and development capability in designing and synthesizing viral vector with functional specificity, and marks another important step for ImmVira's pipeline expansion. ImmVira's OvPENS, the systematic next-generation cancer therapy development platform, is expected to drive more pipelines into clinical stage, expand pipelines to cover broader indications, and capture the large and evolving market of oncolytic virotherapy.
ImmVira is a biotechnology company focused on genetically modified oncolytic viruses as potential cancer therapeutics. The company has developed science, technology and know-how to support ongoing research, development and commercialization of oncolytic viruses on the OvPENS (OV+ Potent, Enabling, Novel & Safe) platform. The OvPENS platform comprises of research, patents, gene-recombinant know-how, manufacturing technology and commercialization analytics to develop next-generation oncolytic viruses that reach drug development targets and that are potent, enabling, novel and safe
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