Oncovita Achieves Complete Remission in Preclinical Models for MVdeltaC Ahead of GMP Manufacturing

Oncovita's preclinical package for MVdeltaC, its genetically modified measles virus candidate, now includes complete remission data across four solid tumour models, placing the French biotech on a defined path toward GMP batch production and a clinical trial start targeted for end of 2027. The data will be presented at EACR 2026 in Budapest, 8–11 June, as poster P-402.

The pharmacology package covers mesothelioma, bladder cancer, triple-negative breast cancer, and neuroblastoma, using PDX models and syngeneic models in immunocompetent mice. In those immunocompetent models, MVdeltaC produced tumour regression through to total disappearance, meeting the threshold equivalent to RECIST complete remission. Animals that fully rejected tumours showed no regrowth on re-challenge, indicating durable antitumour immune memory rather than transient response.

The mechanism centres on RIG-I receptor activation by defective viral RNA molecules generated by the modified measles virus, driving both innate and adaptive immune responses. A parallel AI-assisted analysis conducted with Infinitusbio.AI found MVdeltaC outperformed the unmodified measles virus on 70 of 104 cancer biomarkers assessed. For regulatory and CMC teams, the biological MOA characterisation at this stage is directly relevant to the IND-enabling package and to the immunogenicity sections required under 21 CFR Part 211 and ICH Q10 quality system expectations for advanced therapy candidates.

MVdeltaC holds Orphan Drug Designation from both the US FDA and EMA for mesothelioma, a status that will shape the clinical development plan and the registration pathway. Executive Chairman Jean-François Le Bigot confirmed that GMP batch production is being prepared at an internationally recognised CDMO, with clinical trial initiation targeted by end of 2027. Discussions with venture capital and potential pharma-biotech partners are already under way, framed explicitly around the ODD benefit structure.

The transition from preclinical package to GMP manufacturing at a CDMO represents the next hard checkpoint: process characterisation, comparability studies, and sterility assurance protocols for a viral vector will need to satisfy both FDA and EMA expectations before first-in-human dosing can proceed.

Source: GlobeNewswire via Oncovita press release, 4 June 2026.