ImmVira's Brand New oHSV Product MVR-C5252 Targeting Malignant Glioma Obtained FDA's Orphan Drug Designation

by Samuel Pordengerg Aug 8, 2022 News

ImmVira's brand new oncolytic herpes simplex virus will be available in the U.S. on August 1, 2022.


Malignant glioma has been a challenge for patients and healthcare professionals for a long time. The median overall survival for the disease is between 12 and 14 months, with a 5-year survival range from 4% to 5% and a nearly 100% relapse rate.

MVR-C5252 was developed on ImmVira's new drug development platform and is intended for the treatment of glioma. The only oncolytic viruses that target brain tumors have specific genes that promote the immune response of the tumor microenvironment. The Phase I clinical study for MVR-C5252 is currently being prepared.

The Orphan Drug Act was enacted by the FDA to encourage the development of drugs that target diseases that affect less than 200,000 people. The ODD status will allow MVR-C5252 to enjoy exclusive marketing and development rights, as well as potential decreased wait-time for drug approval, in the United States.

ImmVira's Chairwoman and CEO said, "ODD status granted by FDA to MVR-C5252 means a lot for glioma patients, and also demonstrates FDA's recognition for this product and company's clinical development." The early launch of the candidate product to save more patients' lives will be promoted by ImmVira.

It's about ImmVira.

ImmVira is a company that is focused on the development of novel anti- cancer drugs. Our engineering createdgene delivery mechanisms that are highly oncolytic. Our products have the ability to replicate oncolytic herpes simplex virus and non-replicating exosome. The company has developed science, technology and know how to support ongoing research, development and commercialization of best-in-class mono and combo therapies.

A wide range of solid tumors and hematologic malignancies, to be used as single agent or combination treatment solutions for cancer patients at different stages, unresponsive to immunotherapy or with rare tumors, by various administration methods. The first three oncolytic virus products are being tested in the United States and China.

Immviras brand new OHsv product istargetingmalignantglioma obtaineded-fdas-or

ImmVira is the source of the information.