On June 22, 2021 Targovax ASA (OSE: TRVX), a clinical stage immune-oncology company developing immune activators to target hard-to-treat solid tumors, reported that its lead clinical candidate ONCOS-102 has received Fast Track designation in PD-1-refractory advanced melanoma from the US FDA (Press release, Targovax, JUN 22, 2021, View Source [SID1234584210]).

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The US FDA has granted Fast Track designation to ONCOS-102 based on the current pre-clinical and clinical data package, including mechanistic evidence showing an association between ONCOS-102-induced immune activation and tumor responses. Receiving this designation is an endorsement by the US FDA of the strength and importance of the ONCOS-102 data package in PD-1-refractory advanced melanoma. This Fast Track approval comes in addition to ONCOS-102´s existing Fast Track designation in malignant pleural mesothelioma.

The FDA Fast Track designation is awarded to therapies with potential to address unmet medical needs in serious medical conditions and allows for more frequent interactions with the FDA to expedite clinical development, as well as the regulatory review processes. Fast Track products have high likelihood of receiving Priority Review for a future Biologics License Application (BLA) and may be allowed to submit parts of the application for rolling review to shorten the approval timeline.

Dr. Ingunn Munch Lindvig, VP Regulatory Affairs of Targovax said: "Securing yet another Fast Track designation is a strong endorsement of the potential for ONCOS-102 to benefit a patient population with high unmet medical need. Fast Track simplifies and expedites the regulatory interactions and review process, and further supports the rationale for initiating a Phase 2 trial to target accelerated approval for ONCOS-102 in PD-1-refractory advanced melanoma".