U.S. time, ImmVira’s brand new oncolytic herpes simplex virus (“oHSV”) product MVR-C5252 targeting Malignant Glioma has obtained Orphan Drug Designation (“ODD”) from U.S. Food and Drug Administration (“FDA”).
Malignant glioma has been a special challenge for patients and healthcare professionals for a long time, with limited treatment options including surgical resection, chemotherapy, and/or radiation therapy. The prognosis for the disease also remains poor, with median overall survival (“OS”) varying between 12 – 14 months, a 5-year survival ranging from 4% to 5% and a nearly 100% relapse rate, representing a huge unmet medical need.
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Developed on ImmVira’s OvPENS new drug development platform, MVR-C5252 is designed specifically for the treatment of glioma by specific attenuation to achieve on-target malignant gliocyte killing while maintaining safety profile. MVR-C5252 is also the only oncolytic virus product targeting brain tumors that carries specific exogenous genes to promote the immune response of tumor microenvironment and achieve optimal anti-tumor activity. MVR-C5252 has obtained IND clearance from the U.S. FDA and is currently under preparation for Phase I clinical study.
FDA enacted the Orphan Drug Act to encourage and provide special incentives to pharmaceutical companies that undertake the responsibility of developing orphan drugs that target diseases affecting fewer than 200,000 people in the United States. The ODD status will further accelerate the clinical development and registration of MVR-C5252 in the United States, and will also allow MVR-C5252 to enjoy exclusive marketing and development rights and other benefits, such as protocol assistance from FDA, potential decreased wait-time for drug approval, discounts on certain fees, and eligibility for seven years of market exclusivity in the United States, etc.
Dr. Grace Guoying Zhou, ImmVira‘s Chairwoman and CEO, said, “ODD status granted by FDA to MVR-C5252 means a lot for glioma patients, and also demonstrated FDA’s recognition for this product and company’s clinical development and registration capability as well. ImmVira will continue to advance the clinical development of MVR-C5252 in both U.S. and China, promote the early launch of the candidate product to save more patients’ lives.”