Oncovita’s Lead Oncolytic Virus MVdeltaC Gets FDA Orphan Drug Designation For Pleural Mesothelioma

Oncovita, a biotechnology company focused on developing virus-based immunotherapies for cancer, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead investigational therapy, MVdeltaC, for the treatment of pleural mesothelioma. This rare and aggressive form of cancer affects the lining of the lungs and has very limited treatment options, making it an area of high unmet medical need.

MVdeltaC is an innovative immunotherapy that uses a genetically modified, weakened form of the Schwarz strain measles virus. The therapy is designed to selectively replicate within cancer cells while sparing healthy tissue. This selective replication triggers both direct destruction of tumor cells and a strong immune response against the cancer, offering a dual mechanism of action that could improve outcomes for patients with advanced solid tumors such as pleural mesothelioma.

Stéphane Altaba, CEO of Oncovita, stated, “Receiving Orphan Drug Designation from the FDA for MVdeltaC marks a major milestone for Oncovita and validates our approach of harnessing the potential of measles vaccine viruses to treat solid tumors, particularly rare and devastating cancers such as pleural mesothelioma. This regulatory support strengthens our strategy to advance innovative immunotherapies as we prepare to enter clinical development with MVdeltaC by 2026.”

Dr. Stéphane Champiat, MD, PhD, Head of Medical Affairs at Oncovita, mentioned, “With this designation, Oncovita is now well-positioned to enter the U.S. market with its modified attenuated measles virus for the treatment of pleural mesothelioma. This recognition highlights the promise of this novel approach against one of the most aggressive cancers in medicine.”

The Orphan Drug Designation, granted by the FDA’s Office of Orphan Products Development, is intended to encourage the development of treatments for rare diseases affecting fewer than 200,000 people annually in the United States. With this designation, MVdeltaC is now eligible for several development incentives, including tax credits for clinical trials, exemption from certain FDA application fees, and up to seven years of market exclusivity if the therapy receives regulatory approval. This recognition represents a significant step forward in Oncovita’s efforts to bring new therapeutic options to patients facing hard-to-treat cancers.