Oncovita Receives U.S. FDA Orphan Drug Designation for MVdeltaC in Treating Pleural Mesothelioma
Thursday, June 05, 2025
Oncovita, a biotechnology company focused on virus-based immunotherapies, has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its lead candidate, MVdeltaC. The designation applies to the treatment of pleural mesothelioma, a rare and aggressive form of cancer that currently has limited treatment options.
MVdeltaC is an investigational therapy derived from a genetically modified, weakened version of the Schwarz strain of the measles virus. The virus has been altered to target and replicate specifically in cancer cells, helping to destroy them directly while also triggering an immune response against the tumour. This dual-action approach is designed to offer a new treatment option for patients with advanced solid tumours, including pleural mesothelioma.
The Orphan Drug Designation supports the development of treatments for rare diseases affecting fewer than 200,000 people annually in the United States. It offers developers a range of benefits, including tax credits for clinical trials, exemption from certain FDA fees, and seven years of market exclusivity after regulatory approval.
This regulatory milestone positions Oncovita to progress towards clinical development of MVdeltaC, with plans to begin trials by 2026. The recognition also reflects growing interest in the potential of modified viral therapies to address rare and difficult-to-treat cancers.
Source: globenewswire.com
