Le Lézard
Classified in: Health, Science and technology
Subject: PDT

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

SHENZHEN, China, Aug. 7, 2022 /PRNewswire/ -- On August 1, 2022, 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.

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."

About ImmVira

ImmVira is a biotechnology company focused on development of new generation novel anti-cancer drug vectors. Our advanced engineering created vectors that are highly oncolytic competent and as ideal exogenous gene delivery mechanisms. Leveraging intrinsic mechanism of action and tumor microenvironment modification, our products include replication capable oncolytic herpes simplex virus, and non-replicating exosome and tumor vaccine. The company has developed science, technology and know-how to support ongoing research, development and commercialization of best-in-class mono and combo therapies on the OvPENS (Oncological vector+ Potent, Enabling, Novel & Safe) platform.

Our clinical stage and development stage pipelines target 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 including intratumoral, as well as first-in-class intravenous and intraperitoneal/pleural/vesical injections. The first three oncolytic virus products are currently undergoing five Phase I or Phase II clinical trials in both United States and China.


These press releases may also interest you

at 03:14
The Walt Disney Company today forced a channel blackout on DISH TV and SLING TV, affecting favorites such as ESPN, FX, Disney Channel, Freeform and National Geographic, as well as ABC locals in eight markets. The media conglomerate declined DISH's...

30 sep 2022
The "Humanoid Robot Market by Component and Geography - Forecast and Analysis 2022-2026" report has been added to Technavio's offerings. The humanoid robot market is estimated to grow by USD 9.74 billion from 2021 to 2026. In addition, the growth...

30 sep 2022
LAS VEGAS, Sept. 30, 2022 The Kanpai Pandas are excited to announce our newest sponsored athlete, Roy Jones Jr.! Roy has world titles at middleweight, super middleweight, light heavyweight, and heavyweight and has been the only boxer in history to...

30 sep 2022
The Military Robots Market report has been added to Technavio's offering. The military robots market value is anticipated to grow by USD 8.19 billion, at a CAGR of 8.15% during the forecast period....

30 sep 2022
The "Automotive Active Aerodynamics System Market by Application (Mid-sized vehicles and High performance vehicles) and Geography (North America, Europe, APAC, Middle East and Africa, and South America) - Forecast and Analysis 2022-2026" report has...

30 sep 2022
The Process Automation And Instrumentation Market report has been added to Technavio's offering. With ISO 9001:2015 certification, Technavio is proudly partnering with more than 100 Fortune 500 companies for over 16 years....

News published on 7 august 2022 at 20:30 and distributed by: