The French biotechnology company Oncovita announced on Nov. 9, 2026 that the European Commission granted an orphan drug designation for its oncolytic virus, dubbed MVdeltaC, currently in development for the treatment of pleural mesothelioma.
The designation is a significant next step for the oncolytic virus, as it provides significant assistance and incentives for the treatment’s development and smooths some barriers for regulation and market entry once it is approved.
The European Commission orphan drug designation comes after a positive opinion from the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) in September, and comes just over a year after also receiving orphan drug status from the U.S. Food and Drug Administration (FDA).
“The European designation is an important milestone for MVdeltaC, particularly because the EU framework requires a substantiated rationale for potential significant benefit when treatments already exist,” said Oncovita CEO Stéphane Altaba.
“Together with the FDA designation obtained in 2025, it provides further encouragement for our development programme in mesothelioma. Our priority is now to advance our drug candidate into clinical development in late 2027.”
How Do Oncolytic Viruses Treat Mesothelioma?
An oncolytic virus therapy, also known as virotherapy, is a unique and innovative cancer treatment that focuses on the use of genetically modified viruses in order to directly target cancer cells.
Oncolytic viruses are FDA-approved for fighting other types of cancer, but are still being researched in the treatment of mesothelioma. Oncovita’s MVdeltaC is a version of a measles virus modified to target mesothelioma cells, then replicating and killing the cancer cells. Afterwards, the cells release proteins that activate the immune system, causing it to look for other cancer cells.
Next Steps for MVdeltaC and Mesothelioma
Oncovita first released preclinical data on MVdeltaC last year at the International Society for Vaccines Annual Congress, showing efficacy in 70% of tumor cell samples across eight types of cancer, including mesothelioma.
This was followed by additional preclinical data in June at the European Association for Cancer Research congress, which showed cell death and anti-tumor activity in mesothelioma models.
With their orphan drug designations in hand and with promising preclinical data, Oncovita’s next step is to bring MVdeltaC into clinical development. Oncovita announced that it plans to begin its first clinical trial by late 2027.
Sources & Author
- Oncovita Granted Orphan Drug Designation For MVdeltaC in Mesothelioma by the European Commission. Business Insider. Retrieved from https://markets.businessinsider.com/news/stocks/oncovita-granted-orphan-drug-designation-for-mvdeltac-in-mesothelioma-by-the-european-commission-1036737231. Accessed on 11/12/2026.
- MVdeltaC Receives FDA Orphan Drug Designation in Pleural Mesothelioma. OncLive. Retrieved from: https://www.onclive.com/view/mvdeltac-receives-fda-orphan-drug-designation-in-pleural-mesothelioma. Accessed: 11/12/2026.
