Oncovita Granted Orphan Drug Designation For MVdeltaC in Mesothelioma by the European Commission

Following FDA orphan drug designation in 2025, the European decision marks a further milestone as Oncovita prepares to initiate clinical development in late 2027

• The European Commission granted orphan designation on October 19, 2026, following a positive opinion from the EMA’s Committee for Orphan Medicinal Products,
• Oncovita plans to initiate its first clinical trial of MVdeltaC in late 2027.

Paris, France, November 9, 2026 – Oncovita, a French biotechnology company specialized in therapeutic and prophylactic vaccines, today announced that the European Commission has granted orphan medicinal product designation to its lead investigational candidate, MVdeltaC, for the treatment of mesothelioma.
The decision, dated October 19, 2026, follows a positive opinion adopted on September 10, 2026, by the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP). It complements the U.S. Food and Drug Administration (FDA) orphan drug designation for MVdeltaC in pleural mesothelioma, announced in June 2025.

A significant European regulatory milestone

European orphan designation involves an assessment of both the rare-disease criteria and the therapeutic context. Where satisfactory treatments are already authorised, sponsors must provide evidence supporting an assumption that their candidate could offer significant benefit to patients compared with existing methods.

“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 Stéphane Altaba, CEO of Oncovita. “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 ”.

A new immunotherapeutic approach for a challenging cancer

Mesothelioma is a rare and aggressive cancer. Its pleural form affects the membrane surrounding the lungs and is commonly associated with past asbestos exposure. Despite advances in treatment, substantial unmet needs remain, particularly for a majority of patients whose disease progresses with currently available therapies.
MVdeltaC is an investigational immuno-oncolytic therapy developed using Oncovita’s proprietary Measovir® platform. It is based on the attenuated Schwarz strain of the measles vaccine virus, genetically modified to inactivate the viral C virulence factor.
The candidate is designed to combine direct lysis of tumour cells with activation of an anti-tumour immune response. Preclinical studies presented at the European Association for Cancer Research congress in June 2026 reported immunogenic tumour cell death, anti-tumour activity and immune memory in several experimental models of cancer, including mesothelioma models.

“Patients with pleural mesothelioma urgently need additional treatment options, particularly when their disease progresses despite existing therapies,” said Professor Arnaud Scherpereel, a specialist in pneumology and thoracic oncology at Lille University Hospital. “MVdeltaC is a promising therapeutic approach, combining direct tumour cell killing with the potential to stimulate a broader anti-tumour immune response.The preclinical findings are encouraging and strengthen the rationale for bringing this innovative approach into clinical development. I believe MVdeltaC deserves to be investigated clinically for its potential to provide a meaningful new treatment option for patients with mesothelioma.”

Clinical development planned for late 2027

Oncovita is preparing the transition of MVdeltaC into clinical development, including GMP/clinical-grade manufacturing. The company plans to initiate its first clinical trial in late 2027, subject to the required regulatory and ethics approvals.
The European and U.S. orphan designations provide access to incentives intended to support the development of treatments for rare diseases. In the EU, these include protocol assistance, potential reductions in regulatory fees and eligibility for ten years of market exclusivity following marketing authorisation, provided the applicable conditions are met.

About Oncovita
Oncovita is a biotechnology company, spin-off from Institut Pasteur, specializing in the development of measles vaccine virus-based immunotherapies for cancer and prophylactic vaccines based on its proprietary technology Measovir®. This plug-and-play platform allows the construction of candidates with high immunogenic properties to develop safer, scalable and effective treatments, in particular for solid tumors. Our mission is to develop these candidates from the bench up to clinical proof-of-concept.
For more information: contact@oncovita.fr

Press contact
Florence Portejoie – FP2COM
fportejoie@fp2com.fr
+33 6 07 76 82 83

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