Targovax, a Norwegian immune-oncology company, said that its lead candidate ONCOS-102 has secured the fast track designation from the US Food and Drug Administration (FDA) for malignant pleural mesothelioma.
The FDA fast track status to ONCOS-102 was granted based on promising pre-clinical and clinical efficacy related to broad immune activation observed so far, said Targovax.
The designation from the FDA is given to therapies that can potentially address unmet medical requirements in serious medical conditions. It paves the way for more frequent interactions with the regulator to speed up clinical development and also the regulatory review processes.
Dr. Ingunn Munch Lindvig – VP Regulatory Affairs at Targovax said: “Securing this Fast-Track designation is a very important milestone for the ONCOS-102 program. Most importantly Fast-Track validates the strong potential of ONCOS-102 as a future treatment option for solid tumors with high unmet medical need.”
The FDA fast track status follows the orphan drug designation (ODD) for ONCOS-102 from the same regulator and also from the European Medical Agency (EMA) in the mesothelioma indication.