Oncovita, a biotechnology company developing virus-based immunotherapies, announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to its lead investigational therapy MVdeltaC for treating pleural mesothelioma. The designation represents a significant regulatory milestone for the Paris-based company as it advances its novel oncolytic virus platform toward clinical development.
Novel Measles Virus Platform Targets Aggressive Cancer
MVdeltaC is based on a genetically modified attenuated Schwarz strain measles virus, engineered to selectively replicate in tumor cells while stimulating a potent anti-cancer immune response. This dual mechanism combines direct tumor cell lysis with immune system activation, offering a potentially transformative approach for patients with advanced solid tumors.
"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," said Stéphane Altaba, CEO of Oncovita.
The company's proprietary Measovir® platform leverages the measles virus to develop what it describes as safer, scalable, and effective treatments for solid tumors. MVdeltaC is currently at the pre-IND/CTA stage, with Oncovita preparing to enter clinical development by 2026.
Addressing Critical Unmet Medical Need
Pleural mesothelioma represents one of the most challenging cancers in oncology, developing in the pleura membrane surrounding the lungs and often linked to prolonged asbestos exposure. Approximately 3,000 new cases are diagnosed annually in the United States, with patients facing poor prognosis and severely limited treatment options, particularly in cases of relapse or resistance to existing therapies.
"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," added Dr. Stéphane Champiat, MD, PhD, Head of Medical Affairs at Oncovita.
Regulatory Benefits Support Development Path
The FDA's Office of Orphan Products Development grants Orphan Drug Designation to support therapies for rare diseases affecting fewer than 200,000 people annually in the United States. This designation provides substantial development advantages, including tax credits for eligible clinical trials, waiver of FDA application fees, and up to seven years of market exclusivity following product approval.
These regulatory incentives are particularly valuable for biotechnology companies developing treatments for rare cancers, where traditional market dynamics may not support the substantial investment required for clinical development and commercialization.
Institut Pasteur Spin-off Advances Oncolytic Virus Field
Oncovita emerged as a biotechnology spin-off from the Institut Pasteur, specializing in virus-based immunotherapies with particular focus on oncolytic measles virus platforms. The company's approach represents part of a broader renaissance in oncolytic virus therapies, which harness engineered viruses to selectively target cancer cells while avoiding healthy tissue.
The regulatory support strengthens Oncovita's strategy to advance innovative immunotherapies in the competitive oncology landscape, where companies are increasingly exploring novel mechanisms to overcome the limitations of conventional cancer treatments.
