The FDA has granted orphan drug designation to MVdeltaC, a genetically modified measles virus developed by French biotech Oncovita, for the treatment of pleural mesothelioma. The designation recognizes the therapy’s potential to address a disease with fewer than 200,000 U.S. patients annually and limited treatment options.
How MVdeltaC Works
MVdeltaC is an oncolytic virus, a type of immunotherapy that uses modified viruses to selectively infect and destroy cancer cells while leaving healthy tissue intact.
The therapy is based on an attenuated Schwarz strain measles virus, genetically engineered with a key modification: deletion of the C protein that normally helps viruses evade immune detection. This deletion triggers a stronger immune response against tumors.
Key mechanisms:
- Targets tumor cells via the CD46 receptor (overexpressed on cancer cells)
- Induces immunogenic cell death, alerting the immune system to attack
- Reactivates “cold” tumors that evade standard immunotherapy
- Combines well with checkpoint inhibitors
Preclinical Results
Laboratory studies show promising results for mesothelioma:
| Metric | Result |
|---|---|
| Tumor mass reduction | 60-70% in mesothelioma models |
| Potency vs standard measles | 2-3x more effective at killing tumor cells |
| Activity rate | >70% of human tumor cell lines tested |
| Survival with combo therapy | 100% in mice (with anti-CTLA-4) |
The combination with anti-CTLA-4 antibody immunotherapy achieved complete survival in animal models, suggesting MVdeltaC may enhance the effectiveness of existing checkpoint inhibitors.
Orphan drug designation provides Oncovita with tax credits for clinical trials, waived FDA application fees, and up to seven years of market exclusivity if approved. It does not guarantee approval but signals FDA recognition of unmet medical need.
Path to Human Trials
Oncovita plans to begin first-in-human trials by 2026, initially focusing on solid tumors that have not responded to checkpoint inhibitors. Mesothelioma is a priority indication given the limited options for patients after first-line chemotherapy and immunotherapy.
The company, a spinoff from Institut Pasteur in Paris, has focused specifically on measles-based cancer therapies. MVdeltaC is their lead candidate.
What This Means for Patients
For mesothelioma patients, MVdeltaC represents a fundamentally different approach than current treatments:
- Novel mechanism: Unlike chemotherapy or standard immunotherapy, oncolytic viruses directly infect tumors
- Immune activation: May help patients whose tumors are “cold” and unresponsive to checkpoint inhibitors
- Combination potential: Early data suggests synergy with existing immunotherapies
Clinical trials are still at least a year away. Patients interested in novel therapies should discuss current clinical trial options with their oncology team.
What is MVdeltaC?▼
MVdeltaC is a genetically modified measles virus designed to selectively infect and kill cancer cells. Developed by French biotech Oncovita, it has received FDA orphan drug designation for pleural mesothelioma. The modification removes the C protein, triggering stronger immune responses against tumors.
What is orphan drug designation?▼
FDA orphan drug designation is granted for therapies targeting diseases affecting fewer than 200,000 Americans annually. It provides tax credits, fee waivers, and seven years market exclusivity if approved. It does not guarantee the drug will be approved.
When will clinical trials begin?▼
Oncovita plans to begin first-in-human trials by 2026 for solid tumors including mesothelioma. The therapy is currently at the pre-IND/CTA stage, meaning regulatory submissions are being prepared.
How effective was MVdeltaC in studies?▼
In preclinical models, MVdeltaC reduced tumor mass by 60-70% and was 2-3x more potent than standard measles virus. Combined with anti-CTLA-4 immunotherapy, it achieved 100% survival in mice with mesothelioma.